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  • 251. Ezekowitz, Michael D.
    et al.
    Kent, Anthony P.
    Pogue, Janice
    Reilly, Paul A.
    Brueckmann, Martina
    Clemens, Andreas
    Yusuf, Salim
    Wallentin, Lars
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Connolly, Stuart J.
    RE-LY and RELY-ABLE: Long-term Follow-up of Patients With Non-valvular Atrial Fibrillation Receiving Dabigatran Etexilate for Up to 6.7 Years2013In: Circulation, ISSN 0009-7322, E-ISSN 1524-4539, Vol. 128, no 22Article in journal (Other academic)
  • 252.
    Ezekowitz, Michael D.
    et al.
    Thomas Jefferson Univ, Sidney Kimmel Med Coll, Philadelphia, PA 19107 USA;Lankenau Heart Ctr, Wynnewood, PA 19096 USA;Bryn Mawr Hosp, Bryn Mawr, PA USA.
    Pollack, Charles V., Jr.
    Thomas Jefferson Univ, Philadelphia, PA 19107 USA.
    Halperin, Jonathan L.
    Icahn Sch Med, New York, NY USA.
    England, Richard D.
    Pfizer, Groton, CT USA.
    Nguyen, Sandra VanPelt
    Pfizer, Groton, CT USA.
    Spahr, Judith
    Thomas Jefferson Univ, Philadelphia, PA 19107 USA.
    Sudworth, Maria
    Pfizer, London, England.
    Cater, Nilo B.
    Pfizer, New York, NY USA.
    Breazna, Andrei
    Pfizer, New York, NY USA.
    Oldgren, Jonas
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Kirchhof, Paulus
    Univ Birmingham, Inst Cardiovasc Sci, SWBH Trust, Birmingham, W Midlands, England;UHB NHS Trust, Birmingham, W Midlands, England.
    Apixaban compared to heparin/vitamin K antagonist in patients with atrial fibrillation scheduled for cardioversion: the EMANATE trial2018In: European Heart Journal, ISSN 0195-668X, E-ISSN 1522-9645, Vol. 39, no 32, p. 2959-2971Article in journal (Refereed)
    Abstract [en]

    Aim The primary objective was to compare apixaban to heparin/ vitamin K antagonist (VKA) in patients with atrial fibrillation (AF) and <= 48 h anticoagulation prior to randomization undergoing cardioversion. Methods One thousand five hundred patients were randomized. The apixaban dose of 5mg b.i.d. was reduced to 2.5 mg b.i.d. in patients with two of the following: age >= 80 years, weight <= 60 kg, or serum creatinine >= 133 mu mol/L. To expedite cardioversion, at the discretion of the investigator, imaging and/or a loading dose of 10 mg (down-titrated to 5 mg) was allowed. The endpoints for efficacy were stroke, systemic embolism (SE), and death. The endpoints for safety were major bleeding and clinically relevant non-major (CRNM) bleeding. Results There were 1038 active and 300 spontaneous cardioversions; 162 patients were not cardioverted. Imaging was performed in 855 patients, and 342 received a loading dose of apixaban. Comparing apixaban to heparin/VKA in the full analysis set, there were 0/753 vs. 6/747 strokes [relative risk (RR) 0; 95% confidence interval (95% CI) 0-0.64; nominal P = 0.015], no SE, and 2 vs. 1 deaths (RR 1.98; 95% CI 0.19-54.00; nominal P > 0.999). In the safety population, there were 3/735 vs. 6/721 major (RR 0.49; 95% CI 0.10-2.07; nominal P = 0.338) and 11 vs. 13 CRNM bleeding events (RR 0.83; 95% CI 0.34-1.89; nominal P = 0.685). On imaging, 60/61 with thrombi continued randomized treatment; all (61) were without outcome events. Conclusions Rates of strokes, systemic emboli, deaths, and bleeds were low for both apixaban and heparin/VKA treated AF patients undergoing cardioversion.

  • 253.
    Ezekowitz, Michael D.
    et al.
    Thomas Jefferson Univ, Sidney Kimmel Med Coll, Philadelphia, PA 19107 USA.;Lankenau Med Ctr, Wynnewood, PA USA..
    Pollack, Charles V.
    Thomas Jefferson Univ, Philadelphia, PA 19107 USA..
    Sanders, Paul
    Pfizer, London, England..
    Halperin, Jonathan L.
    Icahn Sch Med Mt Sinai, New York, NY 10029 USA..
    Spahr, Judith
    Lankenau Inst Med Res, Wynnewood, PA USA..
    Cater, Nilo
    Pfizer, New York, NY USA..
    Petkun, William
    Bristol Myers Squibb Inc, Princeton, NJ USA..
    Breazna, Andrei
    Pfizer, New York, NY USA..
    Kirchhof, Paulus
    Univ Birmingham, SWBH UHB NHS Trusts, Inst Cardiovasc Sci, Birmingham, W Midlands, England.;Univ Hosp Munster, Dept Cardiol & Angiol, Munster, Germany..
    Oldgren, Jonas
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Apixaban compared with parenteral heparin and/or vitamin K antagonist in patients with nonvalvular atrial fibrillation undergoing cardioversion: Rationale and design of the EMANATE trial2016In: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 179, p. 59-68Article in journal (Refereed)
    Abstract [en]

    Background: Stroke prevention in anticoagulation-nafve patients with atrial fibrillation undergoing cardioversion has not been systematically studied.

    Objective: To determine outcomes in anticoagulation-naive patients (defined as those receiving an anticoagulant for <48 hours during the index episode of atrial fibrillation) scheduled for cardioversion.

    Methods: This is a randomized, prospective, open-label, real-world study comparing apixaban to heparin plus warfarin. Early image-guided cardioversion is encouraged. For apixaban, the usual dose is 5 mg BID with a dose reduction to 2.5 mg BID if 2 of the following are present: age >80 years, weight <60 kg, or serum creatinine >1.5 mg/dL. If cardioversion is immediate, a single starting dose of 10 mg (or 5 mg if the dose is down-titrated) of apixaban is administered. Cardioversion may be attempted up to 90 days after randomization. Patients are followed up for 30 days after cardioversion or 90 days postrandomization if cardioversion is not performed within that timeframe. Outcomes are stroke, systemic embolization, major bleeds, clinically relevant nonmajor bleeding, and death, all adjudication-blinded.

    Statistics: The warfarin-naive cohort from the ARISTOTLE study was considered the closest data set to the patients being recruited into this study. The predicted incidence of stroke, systemic embolism, and major bleeding within 30 days after randomization was approximately 0.75%. To adequately power for a noninferiority trial, approximately 48,000 participants would be needed, a number in excess of feasibility. The figure of 1,500 patients was considered clinically meaningful and achievable.

  • 254.
    Fanaroff, Alexander C.
    et al.
    Duke Univ, Sch Med, Div Cardiol, Durham, NC USA;Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA.
    Clare, Robert
    Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA.
    Pieper, Karen S.
    Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA.
    Mahaffey, Kenneth W.
    Stanford Univ, Sch Med, Stanford Ctr Clin Res, Stanford, CA 94305 USA.
    Melloni, Chiara
    Duke Univ, Sch Med, Div Cardiol, Durham, NC USA;Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA.
    Green, Jennifer B.
    Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA;Duke Univ, Div Endocrinol, Sch Med, Durham, NC USA.
    Alexander, John H.
    Duke Univ, Sch Med, Div Cardiol, Durham, NC USA;Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA.
    Jones, W. Schuyler
    Duke Univ, Sch Med, Div Cardiol, Durham, NC USA;Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA.
    Harrison, Robert W.
    Duke Univ, Sch Med, Div Cardiol, Durham, NC USA;Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA.
    Mehta, RaJendra H.
    Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA.
    Povsic, Thomas J.
    Duke Univ, Sch Med, Div Cardiol, Durham, NC USA;Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA.
    Moreira, Humberto G.
    Univ Sao Paulo, Heart Inst InCor, Med Sch, Sao Paulo, Brazil.
    Ai-Khatib, Sana M.
    Duke Univ, Sch Med, Div Cardiol, Durham, NC USA;Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA.
    Roe, Matthew T.
    Duke Univ, Sch Med, Div Cardiol, Durham, NC USA;Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA.
    Kong, David F.
    Duke Univ, Sch Med, Div Cardiol, Durham, NC USA;Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA.
    Mathews, Robin
    Duke Univ, Sch Med, Div Cardiol, Durham, NC USA;Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA.
    Tricoci, Pierluigi
    CSL Behring, King Of Prussia, PA USA.
    Holman, Rury R.
    Univ Oxford, Diabet Trials Unit, Oxford Ctr Diabet Endocrinol & Metab, Oxford, England.
    Wallentin, Lars
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Held, Claes
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Califf, Robert M.
    Duke Univ, Sch Med, Div Cardiol, Durham, NC USA;Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA;Verily Life Sci, San Francisco, CA USA.
    Alexander, Karen P.
    Duke Univ, Sch Med, Div Cardiol, Durham, NC USA;Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA.
    Lopes, Renato D.
    Duke Univ, Sch Med, Div Cardiol, Durham, NC USA;Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA.
    Frequency, Regional Variation, and Predictors of Undetermined Cause of Death in Cardiometabolic Clinical Trials: A Pooled Analysis of 9259 Deaths in 9 Trials2019In: Circulation, ISSN 0009-7322, E-ISSN 1524-4539, Vol. 139, no 7, p. 863-873Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Modern cardiometabolic clinical trials often include cardiovascular death as a component of a composite primary outcome, requiring central adjudication by a clinical events committee to classify cause of death. However, sometimes the cause of death cannot be determined from available data. The US Food and Drug Administration has indicated that this circumstance should occur only rarely, but its prevalence has not been formally assessed. METHODS: Data from 9 global clinical trials (2009-2017) with long-term follow-up and blinded, centrally adjudicated cause of death were used to calculate the proportion of deaths attributed to cardiovascular, noncardiovascular, or undetermined causes by therapeutic area (diabetes mellitus/pre-diabetes mellitus, stable atherosclerosis, atrial fibrillation, and acute coronary syndrome), region of patient enrollment, and year of trial manuscript publication. Patient-and trial-level variables associated with undetermined cause of death were identified using a logistic model. RESULTS: Across 127 049 enrolled participants from 9 trials, there were 9259 centrally adjudicated deaths: 5012 (54.1%) attributable to cardiovascular causes, 2800 (30.2%) attributable to noncardiovascular causes, and 1447 (15.6%) attributable to undetermined causes. There was variability in the proportion of deaths ascribed to undetermined causes by trial therapeutic area, region of enrollment, and year of trial manuscript publication. On multivariable analysis, acute coronary syndrome or atrial fibrillation trial (versus atherosclerotic vascular disease or diabetes mellitus/pre-diabetes mellitus), longer time from enrollment to death, more recent trial manuscript publication year, enrollment in North America (versus Western Europe), female sex, and older age were associated with greater likelihood of death of undetermined cause. CONCLUSIONS: In 9 cardiometabolic clinical trials with long-term followup, approximately 16% of deaths had undetermined causes. This provides a baseline for quality assessment of clinical trials and informs operational efforts to potentially reduce the frequency of undetermined deaths in future clinical research.

  • 255.
    Fanaroff, Alexander C.
    et al.
    Duke Univ, Div Cardiol, Durham, NC USA.; Duke Clinical Research Institute, Duke University, Durham, NC, USA.
    Hasselblad, Vic
    Duke Clinical Research Institute, Duke University, Durham, NC, USA.
    Roe, Matthew T.
    Duke Univ, Div Cardiol, Durham, NC USA.;Duke Univ, Duke Clin Res Inst, Durham, NC USA..
    Bhatt, Deepak L.
    Brigham and Women's Hospital Heart & Vascular Center, Harvard Medical School, Boston, MA, USA.
    James, Stefan K
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Steg, Ph Gabriel
    FACT (French Alliance for Cardiovascular Clinical Trials), DHU FIRE, INSERM Unité 1148, Université Paris-Diderot, Hôpital Bichat, Assistance-Publique-Hôpitaux de Paris, France.; NHLI, Imperial College, Royal Brompton Hospital, London, UK .
    Gibson, C. Michael
    Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, MA, USA.
    Ohman, E. Magnus
    Division of Cardiology, Duke University, Durham, NC, USA.; Duke Clinical Research Institute, Duke University, Durham, NC, USA.
    Antithrombotic agents for secondary prevention after acute coronary syndromes: A systematic review and network meta-analysis2017In: International Journal of Cardiology, ISSN 0167-5273, E-ISSN 1874-1754, Vol. 241, p. 87-96Article in journal (Refereed)
    Abstract [en]

    Background: Nine oral antithrombotic medications currently available in the United States and Europe have been studied in clinical trials for secondary prevention of cardiac events following acute coronary syndrome (ACS). Few combinations of these medications have been directly compared, and studies have used multiple different comparator regimens.

    Methods: We performed a systematic review and network meta-analysis of randomized controlled trials evaluating one or more available oral antithrombotic therapies in patients with ACS or prior myocardial infarction (MI). Co-primary outcomes were all-cause and cardiovascular mortality compared with imputed placebo and aspirin monotherapy.

    Results: Forty-seven studies (196,057 subjects) met inclusion criteria and were included in the systematic review. Almost all studies tested either aspirin monotherapy compared with placebo or a combination of antithrombotic agents that included aspirin. Nearly all regimens reduced all-cause and cardiovascular mortality compared with imputed placebo. However, compared with imputed aspirin monotherapy, only combination therapy with aspirin plus ticagrelor was associated with lower cardiovascular mortality (OR 0.80, 95% CI 0.68-0.93), and triple therapy with aspirin, clopidogrel, and very low dose rivaroxaban was associated with lower all-cause mortality (OR 0.67, 95% CI 0.49-0.90). Major bleeding was increased 45-95% with dual antithrombotic therapy, and 2-6-fold with triple therapy.

    Conclusion: Few combinations of antithrombotic therapy were associated with a reduction inmortality compared with aspirin monotherapy, highlighting the difficulty in clinical interpretation of composite ischemic endpoints. Future studies may need to focus on limiting the number of antithrombotic therapies tested in combination to best balance ischemic event reduction and bleeding.

  • 256.
    Fanaroff, Alexander C.
    et al.
    Duke Univ, Med Ctr, Div Cardiol, Dept Med, Durham, NC 27710 USA.;Duke Univ, Med Ctr, Duke Clin Res Inst, 2400 Pratt St, Durham, NC 27705 USA..
    James, Stefan K.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Weisz, Giora
    Columbia Univ, Div Cardiol, New York, NY USA.;Cardiovasc Res Fdn, New York, NY USA.;Shaare Zedek Med Ctr, Dept Cardiol, Jerusalem, Israel..
    Prather, Kristi
    Duke Univ, Med Ctr, Duke Clin Res Inst, 2400 Pratt St, Durham, NC 27705 USA..
    Anstrom, Kevin J.
    Duke Univ, Med Ctr, Duke Clin Res Inst, 2400 Pratt St, Durham, NC 27705 USA..
    Mark, Daniel B.
    Duke Univ, Med Ctr, Div Cardiol, Dept Med, Durham, NC 27710 USA.;Duke Univ, Med Ctr, Duke Clin Res Inst, 2400 Pratt St, Durham, NC 27705 USA..
    Ben-Yehuda, Ori
    Cardiovasc Res Fdn, New York, NY USA..
    Alexander, Karen P.
    Duke Univ, Med Ctr, Div Cardiol, Dept Med, Durham, NC 27710 USA.;Duke Univ, Med Ctr, Duke Clin Res Inst, 2400 Pratt St, Durham, NC 27705 USA..
    Stone, Gregg W.
    Columbia Univ, Div Cardiol, New York, NY USA.;Cardiovasc Res Fdn, New York, NY USA..
    Ohman, E. Magnus
    Duke Univ, Med Ctr, Div Cardiol, Dept Med, Durham, NC 27710 USA.;Duke Univ, Med Ctr, Duke Clin Res Inst, 2400 Pratt St, Durham, NC 27705 USA..
    Ranolazine After Incomplete Percutaneous Coronary Revascularization in Patients With Versus Without Diabetes Mellitus: RIVER-PCI Trial2017In: Journal of the American College of Cardiology, ISSN 0735-1097, E-ISSN 1558-3597, Vol. 69, no 18, p. 2304-2313Article in journal (Refereed)
    Abstract [en]

    BACKGROUND Chronic angina is more common in patients with diabetes mellitus (DM) with poor glucose control. Ranolazine both treats chronic angina and improves glucose control.

    OBJECTIVES This study sought to examine ranolazine's antianginal effect in relation to glucose control.

    METHODS The authors performed a secondary analysis of the RIVER-PCI (Ranolazine in Patients with Incomplete Revascularization after Percutaneous Coronary Intervention) trial, a clinical trial in which 2,604 patients with chronic angina and incomplete revascularization following percutaneous coronary intervention were randomized to ranolazine versus placebo. Mixed-effects models were used to compare the effects of ranolazine versus placebo on glycosylated hemoglobin (HbA(1c)) at 6- and 12-month follow-up. Interaction between baseline HbA(1c) and ranolazine's effect on Seattle Angina Questionnaire angina frequency at 6 and 12 months was tested.

    RESULTS Overall, 961 patients (36.9%) had DM at baseline. Compared with placebo, ranolazine significantly decreased HbA(1c) by 0.42 +/- 0.08% (adjusted mean difference +/- SE) and 0.44 +/- 0.08% from baseline to 6 and 12 months, respectively, in DM patients, and by 0.19 +/- 0.02% and 0.20 +/- 0.02% at 6 and 12 months, respectively, in non-DM patients. Compared with placebo, ranolazine significantly reduced Seattle Angina Questionnaire angina frequency at 6 months among DM patients but not at 12 months. The reductions in angina frequency were numerically greater among patients with baseline HbA(1c) >= 7.5% than those with HbA(1c) <7.5% (interaction p = 0.07).

    CONCLUSIONS In patients with DM and chronic angina with incomplete revascularization after percutaneous coronary intervention, ranolazine's effect on glucose control and angina at 6 months was proportionate to baseline HbA(1c), but the effect on angina dissipated by 12 months.

  • 257.
    Fang, Fang
    et al.
    Karolinska Inst, Dept Med Epidemiol & Biostat, Box 281, S-17177 Stockholm, Sweden.
    Hållmarker, Ulf
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Mora Hosp, Dept Internal Med, Mora, Sweden.
    James, Stefan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Ingre, Caroline
    Karolinska Univ Hosp, Dept Neurol, Stockholm, Sweden.; Karolinska Inst, Dept Clin Neurosci, S-17177 Stockholm, Sweden.
    Michaëlsson, Karl
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Orthopaedics.
    Ahlbom, Anders
    Karolinska Inst, Inst Environm Med, S-17177 Stockholm, Sweden.
    Feychting, Maria
    Karolinska Inst, Inst Environm Med, S-17177 Stockholm, Sweden.
    Amyotrophic lateral sclerosis among cross-country skiers in Sweden.2016In: European Journal of Epidemiology, ISSN 0393-2990, E-ISSN 1573-7284, Vol. 31, no 3, p. 247-253Article in journal (Refereed)
    Abstract [en]

    A highly increased risk of amyotrophic lateral sclerosis (ALS) has been suggested among professional athletes. We aimed to examine whether long distance cross-country skiers have also a higher risk of ALS and whether the increased risk was modified by skiing performance. We followed 212,246 cross-country skiers in the Swedish Vasaloppet cohort and a random selection of 508,176 general Swedes not participating in the Vasaloppet during 1989-2010. The associations between cross-country skiing as well as skiing performance (i.e., type of race, finishing time and number of races) and the consequent risk of ALS were estimated through hazard ratios (HRs) derived from Cox model. During the study, 39 cases of ALS were ascertained among the skiers. The fastest skiers (100-150 % of winner time) had more than fourfold risk of ALS (HR 4.31, 95 % confidence interval [CI] 1.78-10.4), as compared to skiers that finished at >180 % of winner time. Skiers who participated >4 races during this period had also a higher risk (HR 3.13, 95 % CI 1.37-7.17) than those participated only one race. When compared to the non-skiers, the fastest skiers still had a higher risk (HR 2.08, 95 % CI 1.12-3.84), as skiers who had >4 races (HR 1.88, 95 % CI 1.05-3.35), but those finishing at >180 % of winner time had a lower risk (HR 0.46, 95 % CI 0.24-0.87). In conclusion, long distance cross-country skiing is associated with a higher risk of ALS, but only among the best skiers; recreational skiers appear to have a largely reduced risk.

  • 258.
    Farkhooy, Amir
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Flachskampf, Frank A
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    The most important publications of the past year in echocardiography2013In: Herz, ISSN 0340-9937, E-ISSN 1615-6692, Vol. 38, no 1, p. 10-17Article in journal (Refereed)
    Abstract [en]

    We review the published literature on clinical echocardiography of the past year. Key topics were valvular heart disease, in particular aortic stenosis, and the imaging requirements for transcatheter aortic valve implantation. Three-dimensional echocardiography and deformation imaging have yielded important new insights in valvular heart disease. Other key fields have been assessment of heart failure, in particular heart failure with preserved ejection fraction, and the relationship of this condition with diastolic dysfunction and left atrial function. Functional imaging of cardiomyopathies was also an important topic.

  • 259. Farooq, V.
    et al.
    Serruys, P. W.
    Holmes, D. R.
    Kappetein, A. P.
    Mack, M.
    Feldman, T.
    Dawkins, K. D.
    Mohr, F. W.
    James, Stefan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Ståhle, Elisabeth
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Thoracic Surgery.
    The long term (4-year) prognostic significance of abnormal cardiac enzyme rises in patients treated with surgical or percutaneous revascularisation: a substudy from the SYNTAX trial2012In: European Heart Journal, ISSN 0195-668X, E-ISSN 1522-9645, Vol. 33, no Suppl 1, p. 500-500Article in journal (Other academic)
  • 260. Farooq, Vasim
    et al.
    Girasis, Chrysafios
    Magro, Michael
    Onuma, Yoshinobu
    Morel, Marie Angèle
    Heo, Jung Ho
    Garcia-Garcia, Hector
    Kappetein, Arie Pieter
    van den Brand, Marcel
    Holmes, David R
    Mack, Michael
    Feldman, Ted
    Colombo, Antonio
    Ståhle, Elisabeth
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Thoracic Surgery.
    James, Stefan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Carrié, Didier
    Fournial, Gerard
    van Es, Gerrit-Anne
    Dawkins, Keith D
    Mohr, Friedrich W
    Morice, Marie-Claude
    Serruys, Patrick W
    The CABG SYNTAX Score - an angiographic tool to grade the complexity of coronary disease following coronary artery bypass graft surgery: from the SYNTAX Left Main Angiographic (SYNTAX-LE MANS) substudy2013In: EuroIntervention, ISSN 1774-024X, E-ISSN 1969-6213, Vol. 8, no 11, p. 1277-1285Article in journal (Refereed)
    Abstract [en]

    AIMS: The SYNTAX Score (SXscore) has established itself as an important prognostic tool in patients undergoing percutaneous coronary intervention (PCI). A limitation of the SXscore is the inability to differentiate outcomes in patients who have undergone prior coronary artery bypass graft (CABG) surgery. The CABG SXscore was devised to address this limitation.

    METHODS AND RESULTS: In the SYNTAX-LE MANS substudy 115 patients with unprotected left main coronary artery disease (isolated or associated with one, two or three-vessel disease) treated with CABG were prospectively assigned to undergo a 15-month coronary angiogram. An independent core laboratory analysed the baseline SXscore prior to CABG. The 15-month CABG SXscore was calculated by a panel of three interventional cardiologists. The CABG SXscore was calculated by determining the standard SXscore in the "native" coronary vessels ("native SXscore") and deducting points based on the importance of the diseased coronary artery segment (Leaman score) that have a functioning bypass graft anastomosed distally. Points relating to intrinsic coronary disease, such as bifurcation disease or calcification, remain unaltered. The mean 15-month CABG SXscore was significantly lower compared to the mean baseline SXscore (baseline SXscore 31.6, SD 13.1; 15-month CABG SXscore 21.2, SD 11.1; p<0.001). Reproducibility analyses (kappa [k] statistics) indicated a substantial agreement between CABG SXscore measurements (k=0.70; 95% CI [0.50-0.90], p<0.001), with the points deducted to calculate the CABG SXscore the most reproducible measurement (k=0.74; 95% CI [0.53-0.95], p<0.001). Despite the limited power of the study, four-year outcome data (Kaplan-Meier curves) demonstrated a trend towards reduced all-cause death (9.1% vs. 1.8%, p=0.084) and death/CVA/MI (16.4% vs. 7.0%, p=0.126) in the low compared to the high CABG SXscore group.

    CONCLUSIONS: In this pilot study the calculation of the CABG SXscore appeared feasible, reproducible and may have a long-term prognostic role in patients with complex coronary disease undergoing surgical revascularisation. Validation of this new scoring methodology is required.

  • 261. Farooq, Vasim
    et al.
    Girasis, Chrysafios
    Magro, Michael
    Onuma, Yoshinobu
    Morel, Marie-Angele
    Heo, Jung Ho
    Garcia-Garcia, Hector M.
    Kappetein, Arie Pieter
    van den Brand, Marcel
    Holmes, David R.
    Mack, Michael
    Feldman, Ted
    Colombo, Antonio
    Ståhle, Elisabeth
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Thoracic Surgery.
    James, Stefan K.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Carrie, Didier
    Fournial, Gerard
    van Es, Gerrit Anne
    Dawkins, Keith D.
    Mohr, Friedrich W.
    Morice, Marie-Claude
    Serruys, Patrick W.
    The coronary artery bypass graft SYNTAX Score: final five-year outcomes from the SYNTAX-LE MANS left main angiographic substudy2013In: EuroIntervention, ISSN 1774-024X, E-ISSN 1969-6213, Vol. 9, no 8, p. 1009-1010Article in journal (Refereed)
  • 262. Farooq, Vasim
    et al.
    Serruys, Patrick W
    Garcia-Garcia, Hector M
    Zhang, Yaojun
    Bourantas, Christos V
    Holmes, David R
    Mack, Michael
    Feldman, Ted
    Morice, Marie-Claude
    Ståhle, Elisabeth
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Thoracic Surgery.
    James, Stefan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Colombo, Antonio
    Diletti, Roberto
    Papafaklis, Michail I
    de Vries, Ton
    Morel, Marie-Angèle
    van Es, Gerrit Anne
    Mohr, Friedrich W
    Dawkins, Keith D
    Kappetein, Arie-Pieter
    Sianos, Georgios
    University Hospital Uppsala, Uppsala, Sweden.
    Boersma, Eric
    The Negative Impact of Incomplete Angiographic Revascularization on Clinical Outcomes and Its Association With Total Occlusions: The SYNTAX (Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) Trial2013In: Journal of the American College of Cardiology, ISSN 0735-1097, E-ISSN 1558-3597, Vol. 61, no 3, p. 282-294Article in journal (Refereed)
    Abstract [en]

    OBJECTIVES:

    The study sought to evaluate the clinical impact of angiographic complete (CR) and incomplete (ICR) revascularization and its association with the presence of total occlusions (TO), after percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery in the "all-comers" SYNTAX (Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) trial.

    BACKGROUND:

    In patients with complex coronary artery disease undergoing PCI or CABG, the long-term prognostic implications of CR versus ICR is unsettled.

    METHODS:

    In this post hoc study, consisting of randomized (n = 1,800) and nested PCI (n = 198) and CABG (n = 649) registries, 4-year clinical outcomes were compared in groups, with and without angiographic CR, in the PCI and CABG arms. Clinical outcomes were analyzed with Kaplan-Meier estimates, log-rank comparisons, and Cox regression analyses. Multivariate predictors of ICR were determined. Similar analyses were undertaken in the TO and non-TO treated groups of both study arms.

    RESULTS:

    Angiographic CR was achieved in 52.8% of the PCI arm and 66.9% of the CABG arm. Within the PCI and CABG arms, ICR (compared with CR) seemed to be a surrogate marker of a greater burden of anatomical coronary complexity and clinical comorbidity and was associated with significantly higher frequencies of 4-year mortality, all-cause revascularization, stent thrombosis (PCI arm), and major adverse cardiac and cerebrovascular events. The presence of a TO was the strongest independent predictor of ICR after PCI (hazard ratio: 2.70, 95% confidence interval: 1.98 to 3.67, p < 0.001). Eight hundred and forty patients (PCI: 26.3%, CABG: 36.4%, p < 0.001) were identified to have 1,007 TOs, with 68.1% of TOs located in the proximal-mid coronary vasculature. The findings associating ICR (compared with CR) with higher frequencies of 4-year mortality and major adverse cardiac and cerebrovascular events remained consistent in the TO-treated groups in the PCI and CABG arms.

    CONCLUSIONS:

    Within the PCI and CABG arms of the all-comers SYNTAX trial, angiographically determined ICR has a detrimental impact on long-term clinical outcomes, including mortality. This effect remained consistent in patients with and without TOs.

  • 263. Farooq, Vasim
    et al.
    Serruys, Patrick W.
    Vranckx, Pascal
    Bourantas, Christos V.
    Girasis, Chrysafios
    Holmes, David R.
    Kappetein, Arie Pieter
    Mack, Michael
    Feldman, Ted
    Morice, Marie Claude
    Colombo, Antonio
    Morel, Marie-angele
    de Vries, Ton
    Dawkins, Keith D.
    Mohr, Friedrich W.
    James, Stefan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Ståhle, Elisabeth
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Thoracic Surgery.
    Incidence, correlates, and significance of abnormal cardiac enzyme rises in patients treated with surgical or percutaneous based revascularisation: A substudy from the Synergy between Percutaneous Coronary Interventions with Taxus and Cardiac Surgery (SYNTAX) Trial2013In: International Journal of Cardiology, ISSN 0167-5273, E-ISSN 1874-1754, Vol. 168, no 6, p. 5287-5292Article in journal (Refereed)
    Abstract [en]

    Aims: The aimof the present investigationwas to determine the long-termprognostic association of post-procedural cardiac enzyme elevation within the randomised Synergy between Percutaneous Coronary Intervention (PCI) with TAXUS and Cardiac Surgery (SYNTAX) Trial. Methods: 1800 patients with unprotected left main or de novo three-vessel coronary artery disease were randomised to undergo coronary artery bypass graft (CABG) surgery or PCI. Per protocol patients underwent post-procedural blood sampling with creatine kinase (CK), and the cardiac specific MB iso-enzyme (CK-MB) only if the preceding CK ratiowas = 2x the upper limit of normal (ULN). An independent chemistry laboratory evaluated all collected blood samples. Results: Post-procedural CK sampling was available in 1629 of 1800 patients (90.5%). As per protocol, CK-MB analyses were undertaken in 474 of 491 patients (96.5%) in the CABG arm, and 53 of 61 patients (86.9%) in the PCI arm. Within the CABG arm, despite the limitations of incomplete data, a post-procedural CK-MB ratio <3/>= 3 ULNseparated 4-year mortality into low-and high-risk groups (2.3% vs. 9.5%, p = 0.03). Additionally, in the CABG arm, a post-procedural CK-MB ratio = 3 ULN was associated with an increased frequency of a high SYNTAX Score (= 33) tertile (high [>= 33] SYNTAX Score: 39.5%, intermediate [23-32] SYNTAX Score 31.0%, low [>= 22] SYNTAX Score 29.5%, p = 0.02). Within the PCI arm, a post-procedural CK ratio of >2 or >= 2 ULN separated 4-year mortality into low-and high-risk groups (10.8% vs. 23.3%, p = 0.001). Notably, there was an early (within 6 months) and late (after 2 years) peak in mortality in patients with a post-PCI CK ratio of = 2 ULN. Lack of pre-procedural thienopyridine, carotid artery disease, type 1 diabetes, andpresenceof coronary bifurcationswere independent correlates of a CK ratio = 2 ULNpost-PCI. Conclusion: Cardiac enzyme elevations post-CABG or post-PCI are associatedwith an adverse long-termmortality; the causes of which are multifactorial.

  • 264.
    Faxen, J.
    et al.
    Karolinska Inst, Dept Cardiol, Karolinska Univ Hosp, Stockholm, Sweden..
    Jernberg, T.
    Karolinska Inst, Dept Cardiol, Karolinska Univ Hosp, Stockholm, Sweden..
    Sundström, Johan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Lindahl, Bengt
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Szummer, K.
    Karolinska Inst, Dept Cardiol, Karolinska Univ Hosp, Stockholm, Sweden..
    A risk score for predicting cardiac arrest requiring defibrillation or cardiopulmonary resuscitation for patients admitted with suspected non-ST-elevation acute coronary syndromes2015In: European Heart Journal, ISSN 0195-668X, E-ISSN 1522-9645, Vol. 36, no Suppl. 1, p. 406-406Article in journal (Other academic)
  • 265. Faxen, J.
    et al.
    Sundström, Johan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Lindhagen, Lars
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Lindahl, Bertil
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Jernberg, T.
    Szummer, K.
    Predictors of in-hospital ventricular arrhythmias in patients admitted with suspected non-ST-elevation acute coronary syndrome: data from the SWEDEHEART registry2014In: European Heart Journal, ISSN 0195-668X, E-ISSN 1522-9645, Vol. 35, p. 824-825Article in journal (Refereed)
  • 266. Faxén, Jonas
    et al.
    Hall, Marlous
    Gale, Chris P
    Sundström, Johan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Lindahl, Bertil
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Jernberg, Tomas
    Szummer, Karolina
    A user-friendly risk-score for predicting in-hospital cardiac arrest among patients admitted with suspected non ST-elevation acute coronary syndrome - The SAFER-score2017In: Resuscitation, ISSN 0300-9572, E-ISSN 1873-1570, Vol. 121, p. 41-48Article in journal (Refereed)
    Abstract [en]

    AIM: To develop a simple risk-score model for predicting in-hospital cardiac arrest (CA) among patients hospitalized with suspected non-ST elevation acute coronary syndrome (NSTE-ACS).

    METHODS: Using the Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART), we identified patients (n=242 303) admitted with suspected NSTE-ACS between 2008 and 2014. Logistic regression was used to assess the association between 26 candidate variables and in-hospital CA. A risk-score model was developed and validated using a temporal cohort (n=126 073) comprising patients from SWEDEHEART between 2005 and 2007 and an external cohort (n=276 109) comprising patients from the Myocardial Ischaemia National Audit Project (MINAP) between 2008 and 2013.

    RESULTS: The incidence of in-hospital CA for NSTE-ACS and non-ACS was lower in the SWEDEHEART-derivation cohort than in MINAP (1.3% and 0.5% vs. 2.3% and 2.3%). A seven point, five variable risk score (age ≥60 years (1 point), ST-T abnormalities (2 points), Killip Class >1 (1 point), heart rate <50 or ≥100bpm (1 point), and systolic blood pressure <100mmHg (2 points) was developed. Model discrimination was good in the derivation cohort (c-statistic 0.72) and temporal validation cohort (c-statistic 0.74), and calibration was reasonable with a tendency towards overestimation of risk with a higher sum of score points. External validation showed moderate discrimination (c-statistic 0.65) and calibration showed a general underestimation of predicted risk.

    CONCLUSIONS: A simple points score containing five variables readily available on admission predicts in-hospital CA for patients with suspected NSTE-ACS.

  • 267. Ferreira, Jorge
    et al.
    Ezekowitz, Michael D.
    Connolly, Stuart J.
    Brueckmann, Martina
    Fraessdorf, Mandy
    Reilly, Paul A.
    Yusuf, Salim
    Wallentin, Lars
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Dabigatran compared with warfarin in patients with atrial fibrillation and symptomatic heart failure: a subgroup analysis of the RE-LY trial2013In: European Journal of Heart Failure, ISSN 1388-9842, E-ISSN 1879-0844, Vol. 15, no 9, p. 1053-1061Article in journal (Refereed)
    Abstract [en]

    We evaluated the effects of dabigatran compared with warfarin in the subgroup of patients with previous symptomatic heart failure (HF) in the RE-LY trial. RE-LY compared two fixed and blinded doses of dabigatran (110 and 150 mg twice daily) with open-label warfarin in 18 113 patients with AF at increased risk for stroke. Among 4904 patients with HF, annual rates of stroke or systemic embolism (SE) were 1.92 for patients on warfarin compared with 1.90 for dabigatran 110 mg [hazard ratio (HR) 0.99, 95 confidence interval (CI) 0.691.42] and 1.44 for dabigatran 150 mg (HR 0.75, 95 CI 0.511.10). Annual rates of major bleeding were 3.90 for the group on warfarin, compared with 3.26 for dabigatran 110 mg (HR 0.83, 95 CI 0.641.09) and 3.10 for dabigatran 150 mg (HR 0.79, 95 CI 0.601.03). Rates of intracranial bleeding were significantly lower for both dabigatran dosages compared with warfarin in patients with HF (dabigatran 110 mg vs. warfarin, HR 0.34, 95 CI 0.140.80; dabigatran 150 mg vs. warfarin, HR 0.39, 95 CI 0.170.89). The relative effects of dabigatran vs. warfarin on the occurrence of stroke or SE and major bleeding were consistent among those with and without HF and those with low (40) or preserved (40) LVEF (P interaction not significant). The overall benefits of dabigatran for stroke/SE prevention, and major and intracranial bleeding, relative to warfarin in the RE-LY trial were consistent in patients with and without HF.

  • 268.
    Flachskampf, Frank
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Clinical Physiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Aortic Stenosis in Cancer Survivors After Chest Radiation2018In: JACC Cardiovascular Imaging, ISSN 1936-878X, E-ISSN 1876-7591, Vol. 11, no 8, p. 1081-1083Article in journal (Other academic)
  • 269.
    Flachskampf, Frank A.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    How Exactly Do You Measure That Aorta?: Lessons From Multimodality Imaging2016In: JACC Cardiovascular Imaging, ISSN 1936-878X, E-ISSN 1876-7591, Vol. 9, no 3, p. 227-229Article in journal (Other academic)
  • 270.
    Flachskampf, Frank A.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Is 3-Dimensional Echocardiographic Area Strain Diagnostically Superior to Longitudinal and Circumferential Strain?2014In: Journal of the American College of Cardiology, ISSN 0735-1097, E-ISSN 1558-3597, Vol. 64, no 25, p. 2806-2807Article in journal (Other academic)
  • 271.
    Flachskampf, Frank A.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Stenotic Aortic Valve Area Should it Be Calculated From CT Instead of Echocardiographic Data?2015In: JACC Cardiovascular Imaging, ISSN 1936-878X, E-ISSN 1876-7591, Vol. 8, no 3, p. 258-260Article in journal (Other academic)
  • 272.
    Flachskampf, Frank A.
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Biering-Sorensen, Tor
    Solomon, Scott D.
    Duvernoy, Olov
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Radiology.
    Bjerner, Tomas
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Radiology.
    Smiseth, Otto A.
    Heart Rate Is an Important Consideration for Cardiac Imaging of Diastolic Function Reply2016In: JACC Cardiovascular Imaging, ISSN 1936-878X, E-ISSN 1876-7591, Vol. 9, no 6, p. 758-759Article in journal (Refereed)
  • 273.
    Flachskampf, Frank A.
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Biering-Sörensen, Tor
    Harvard Univ, Brigham & Womens Hosp, Sch Med, Cardiovasc Div, Boston, MA 02115 USA.
    Solomon, Scott D.
    Harvard Univ, Brigham & Womens Hosp, Sch Med, Cardiovasc Div, Boston, MA 02115 USA.
    Duvernoy, Olov
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Radiology.
    Bjerner, Tomas
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Radiology.
    Smiseth, Otto A,
    Univ Oslo, Rikshosp, Oslo Univ Hosp,Dept Cardiol, Ctr Cardiol Innovat,KG Jebsen Cardiac Res Ctr,Ctr, N-0027 Oslo, Norway; Univ Oslo, Rikshosp, Oslo Univ Hosp,Inst Surg Res, Ctr Cardiol Innovat,KG Jebsen Cardiac Res Ctr,Ctr, N-0027 Oslo, Norway.
    Cardiac Imaging to Evaluate Left Ventricular Diastolic Function2015In: JACC Cardiovascular Imaging, ISSN 1936-878X, E-ISSN 1876-7591, Vol. 8, no 9, p. 1071-1093Article in journal (Refereed)
    Abstract [en]

    Left ventricular diastolic dysfunction in clinical practice is generally diagnosed by imaging. Recognition of heart failure with preserved ejection fraction has increased interest in the detection and evaluation of this condition and prompted an improved understanding of the strengths and weaknesses of different imaging modalities for evaluating diastolic dysfunction. This review briefly provides the pathophysiological background for current clinical and experimental imaging parameters of diastolic dysfunction, discusses the merits of echocardiography relative to other imaging modalities in diagnosing and grading diastolic dysfunction, summarizes Lessons from clinical trials that used parameters of diastolic function as an inclusion criterion or endpoint, and indicates current areas of research.

  • 274.
    Flachskampf, Frank A.
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Dilsizian, Vasken
    Leaning Heavily on PET Myocardial Perfusion for Prognosis2014In: JACC Cardiovascular Imaging, ISSN 1936-878X, E-ISSN 1876-7591, Vol. 7, no 3, p. 288-291Article in journal (Other academic)
  • 275.
    Flachskampf, Frank A.
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Klinghammer, Lutz
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences.
    Diagnosis of "Paradoxical" Low-Gradient Aortic Stenosis Patients Reply2013In: Journal of the American College of Cardiology, ISSN 0735-1097, E-ISSN 1558-3597, Vol. 62, no 24, p. 2346-2347Article in journal (Refereed)
  • 276.
    Flachskampf, Frank A.
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Klinghammer, Lutz
    Reply: Invasive Hemodynamic Assessment of "Paradoxical" Low-Flow Severe Aortic Stenosis2013In: Journal of the American College of Cardiology, ISSN 0735-1097, E-ISSN 1558-3597, Vol. 62, no 16, p. 1493-1494Article in journal (Refereed)
  • 277.
    Flachskampf, Frank A.
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Martensson, Mattias
    How should tissue Doppler tracings be measured?2014In: European Heart Journal Cardiovascular Imaging, ISSN 2047-2404, E-ISSN 2047-2412, Vol. 15, no 7, p. 828-829Article in journal (Other academic)
  • 278.
    Flachskampf, Frank A
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Clinical Physiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    von Erffa, Johannes
    Seligmann, Christian
    Reimbursement and the practice of cardiology2012In: Journal of the American College of Cardiology, ISSN 0735-1097, E-ISSN 1558-3597, Vol. 59, no 17, p. 1561-1565Article in journal (Refereed)
  • 279.
    Flachskampf, Frank A
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Wouters, Patrick F
    Edvardsen, Thor
    Evangelista, Artur
    Habib, Gilbert
    Hoffman, Piotr
    Hoffmann, Rainer
    Lancellotti, Patrizio
    Pepi, Mauro
    Recommendations for transoesophageal echocardiography: EACVI update 20142014In: European Heart Journal Cardiovascular Imaging, ISSN 2047-2404, E-ISSN 2047-2412, Vol. 15, no 4, p. 353-365Article in journal (Refereed)
    Abstract [en]

    With this document, we update the recommendations for transoesophageal echocardiography (TOE) of the European Association of Cardiovascular Imaging. The document focusses on the areas of interventional TOE, in particular transcatheter aortic, mitral, and left atrial appendage interventions, as well as on the role of TOE in infective endocarditis, adult congenital heart disease, and aortic disease.

  • 280.
    Flachskampf, Frank
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Clinical Physiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Chandrashekhar, Y.
    Univ Minnesota, Div Cardiol, Minneapolis, MN USA;Vet Affairs Med Ctr, Minneapolis, MN USA.
    Diastolic Function Gets Personal2019In: JACC Cardiovascular Imaging, ISSN 1936-878X, E-ISSN 1876-7591, Vol. 12, no 5, p. 950-952Article in journal (Other academic)
  • 281. Flaker, Greg
    et al.
    Ezekowitz, Michael
    Yusuf, Salim
    Wallentin, Lars
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Noack, Herbert
    Brueckmann, Martina
    Reilly, Paul
    Hohnloser, Stefan H
    Connolly, Stuart
    Efficacy and safety of dabigatran compared to warfarin in patients with paroxysmal, persistent, and permanent atrial fibrillation: results from the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) study2012In: Journal of the American College of Cardiology, ISSN 0735-1097, E-ISSN 1558-3597, Vol. 59, no 9, p. 854-855Article in journal (Refereed)
  • 282. Flaker, Greg
    et al.
    Lopes, Renato D.
    Hylek, Elaine
    Wojdyla, Daniel M.
    Thomas, Laine
    Al-Khatib, Sana M.
    Sullivan, Renee M.
    Hohnloser, Stefan H.
    Garcia, David
    Hanna, Michael
    Amerena, John
    Harjola, Veli-Pekka
    Dorian, Paul
    Avezum, Alvaro
    Keltai, Matyas
    Wallentin, Lars
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Granger, Christopher B.
    Amiodarone, Anticoagulation, and Clinical Events in Patients With Atrial Fibrillation Insights From the ARISTOTLE Trial2014In: Journal of the American College of Cardiology, ISSN 0735-1097, E-ISSN 1558-3597, Vol. 64, no 15, p. 1541-1550Article in journal (Refereed)
    Abstract [en]

    BACKGROUND Amiodarone is an effective medication in preventing atrial fibrillation (AF), but it interferes with the metabolism of warfarin. OBJECTIVES This study sought to examine the association of major thrombotic clinical events and bleeding with the use of amiodarone in the ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) trial. METHODS Baseline characteristics of patients who received amiodarone at randomization were compared with those who did not receive amiodarone. The interaction between randomized treatment and amiodarone was tested using a Cox model, with main effects for randomized treatment and amiodarone and their interaction. Matching on the basis of a propensity score was used to compare patients who received and who did not receive amiodarone at the time of randomization. RESULTS In ARISTOTLE, 2,051 (11.4%) patients received amiodarone at randomization. Patients on warfarin and amiodarone had time in the therapeutic range that was lower than patients not on amiodarone (56.5% vs. 63.0%; p < 0.0001). More amiodarone-treated patients had a stroke or a systemic embolism (1.58%/year vs. 1.19%/year; adjusted hazard ratio [HR]: 1.47, 95% confidence interval [CI]: 1.03 to 2.10; p = 0.0322). Overall mortality and major bleeding rates were elevated, but were not significantly different in amiodarone-treated patients and patients not on amiodarone. When comparing apixaban with warfarin, patients who received amiodarone had a stroke or a systemic embolism rate of 1.24%/year versus 1.85%/year (HR: 0.68, 95% CI: 0.40 to 1.15), death of 4.15%/year versus 5.65%/year (HR: 0.74, 95% CI: 0.55 to 0.98), and major bleeding of 1.86%/year versus 3.06%/year (HR: 0.61, 95% CI: 0.39 to 0.96). In patients who did not receive amiodarone, the stroke or systemic embolism rate was 1.29%/year versus 1.57%/year (HR: 0.82, 95% CI: 0.68 to 1.00), death was 3.43%/year versus 3.68%/year (HR: 0.93, 95% CI: 0.83 to 1.05), and major bleeding was 2.18%/year versus 3.03%/year (HR: 0.72, 95% CI: 0.62 to 0.84). The interaction p values for amiodarone use by apixaban treatment effects were not significant. CONCLUSIONS Amiodarone use was associated with significantly increased stroke and systemic embolism risk and a lower time in the therapeutic range when used with warfarin. Apixaban consistently reduced the rate of stroke and systemic embolism, death, and major bleeding compared with warfarin in amiodarone-treated patients and patients who were not on amiodarone.

  • 283.
    Focks, Jeroen Jaspers
    et al.
    Radboud Univ Nijmegen, Med Ctr, Dept Cardiol, POB 9101, NL-6500 HB Nijmegen, Netherlands..
    Brouwer, Marc A.
    Radboud Univ Nijmegen, Med Ctr, Dept Cardiol, POB 9101, NL-6500 HB Nijmegen, Netherlands..
    Wojdyla, Daniel M.
    Duke Clin Res Inst, Durham, NC USA..
    Thomas, Laine
    Duke Clin Res Inst, Durham, NC USA..
    Lopes, Renato D.
    Duke Clin Res Inst, Durham, NC USA..
    Washam, Jeffrey B.
    Duke Univ, Med Ctr, Duke Heart Ctr, Durham, NC USA..
    Lanas, Fernando
    Univ La Frontera, Dept Cardiol, Temuco, Chile..
    Xavier, Denis
    St Johns Med Coll & Res Inst, Dept Pharmacol & Clin Res, Bangalore, Karnataka, India..
    Husted, Steen
    Hosp Unit West, Dept Med, Herning, Denmark..
    Wallentin, Lars
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Alexander, John H.
    Duke Clin Res Inst, Durham, NC USA..
    Granger, Christopher B.
    Duke Clin Res Inst, Durham, NC USA..
    Verheugt, Freek W. A.
    Radboud Univ Nijmegen, Med Ctr, Dept Cardiol, POB 9101, NL-6500 HB Nijmegen, Netherlands..
    Polypharmacy and effects of apixaban versus warfarin in patients with atrial fibrillation: post hoc analysis of the ARISTOTLE trial2016In: BMJ-BRITISH MEDICAL JOURNAL, ISSN 1756-1833, Vol. 353, article id i2868Article in journal (Refereed)
    Abstract [en]

    OBJECTIVE To determine whether the treatment effect of apixaban versus warfarin differs with increasing numbers of concomitant drugs used by patients with atrial fibrillation. DESIGN Post hoc analysis performed in 2015 of results from ARISTOTLE (apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation)-a multicentre, double blind, double dummy trial that started in 2006 and ended in 2011. PARTICIPANTS 18 201 ARISTOTLE trial participants. INTERVENTIONS In the ARISTOTLE trial, patients were randomised to either 5 mg apixaban twice daily (n=9120) or warfarin (target international normalised ratio range 2.0-3.0; n=9081). In the post hoc analysis, patients were divided into groups according to the number of concomitant drug treatments used at baseline (0-5, 6-8, >= 9 drugs) with a median follow-up of 1.8 years. MAIN OUTCOME MEASURES Clinical outcomes and treatment effects of apixaban versus warfarin (adjusted for age, sex, and country). RESULTS Each patient used a median of six drugs (interquartile range 5-9); polypharmacy (>= 5 drugs) was seen in 13 932 (76.5%) patients. Greater numbers of concomitant drugs were used in older patients, women, and patients in the United States. The number of comorbidities increased across groups of increasing numbers of drugs (0-5, 6-8, >= 9 drugs), as did the proportions of patients treated with drugs that interact with warfarin or apixaban. Mortality also rose significantly with the number of drug treatments (P<0.001), as did rates of stroke or systemic embolism (1.29, 1.48, and 1.57 per 100 patient years, for 0-5, 6-8, and >= 9 drugs, respectively) and major bleeding (1.91, 2.46, and 3.88 per 100 patient years, respectively). Relative risk reductions in stroke or systemic embolism for apixaban versus warfarin were consistent, regardless of the number of concomitant drugs (P-interaction=0.82). A smaller reduction in major bleeding was seen with apixaban versus warfarin with increasing numbers of concomitant drugs (P-interaction=0.017). Patients with interacting (potentiating) drugs for warfarin or apixaban had similar outcomes and consistent treatment effects of apixaban versus warfarin. CONCLUSIONS In the ARISTOTLE trial, three quarters of patients had polypharmacy; this subgroup had an increased comorbidity, more interacting drugs, increased mortality, and higher rates of thromboembolic and bleeding complications. In terms of a potential differential response to anticoagulation therapy in patients with atrial fibrillation and polypharmacy, apixaban was more effective than warfarin, and is at least just as safe.

  • 284.
    Fokkema, Marieke L.
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Univ Groningen, Univ Med Ctr Groningen, Dept Cardiol, Groningen, Netherlands.
    James, Stefan K.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Albertsson, Per
    Sahlgrens Univ Hosp, Dept Cardiol, Gothenburg, Sweden.
    Aasa, Mikael
    Soder Sjukhuset, Dept Cardiol, Stockholm, Sweden.
    Åkerblom, Axel
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Calais, Fredrik
    Univ Orebro, Fac Hlth, Dept Cardiol, Orebro, Sweden.
    Eriksson, Peter
    Umea Univ Hosp, Dept Cardiol, Umea, Sweden.
    Jensen, Jens
    Sundsvall Harnosand Cty Hosp, Karolinska Inst, Dept Med, Stockholm, Sweden.
    Schersten, Fredrik
    Lund Univ, Skane Univ Hosp, Dept Cardiol, Lund, Sweden.
    de Smet, Bart J
    Univ Groningen, Univ Med Ctr Groningen, Dept Cardiol, Groningen, Netherlands; Meander Med Ctr, Dept Cardiol, Amersfoort, Netherlands.
    Sjögren, Iwar
    Falun Lasarett, Dept Cardiol, Falun, Sweden.
    Tornvall, Per
    arolinska Univ Hosp, Dept Cardiol, Stockholm, Sweden.
    Lagerqvist, Bo
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Outcome after percutaneous coronary intervention for different indications: long-term results from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR)2016In: EuroIntervention, ISSN 1774-024X, E-ISSN 1969-6213, Vol. 12, no 3, p. 303-311Article in journal (Refereed)
    Abstract [en]

    Aims: The aim of this study was to evaluate clinical outcome for different indications for PCI in an unselected, nationwide PCI population at short- and long-term follow-up. Methods and results: We evaluated clinical outcome up to six years after PCI in all patients undergoing a PCI procedure for different indications in Sweden between 2006 and 2010. A total of 70,479 patients were treated for stable coronary artery disease (CAD) (21.0%), unstable angina (11.0%), non-ST-elevation myocardial infarction (NSTEMI) (36.6%) and ST-elevation myocardial infarction (STEMI) (31.4%). Mortality was higher in STEMI patients at one year after PCI (9.6%) compared to NSTEMI (4.7%), unstable angina (2.2%) and stable CAD (2.0%). At one year after PCI until the end of follow-up, the adjusted mortality risk (one to six years after PCI) and the risk of myocardial infarction were comparable between NSTEMI and STEMI patients and lower in patients with unstable angina and stable CAD. The adjusted risk of stent thrombosis and heart failure was highest in STEMI patients. Conclusions: The risk of short-term mortality, heart failure and stent thrombosis is highest for STEMI patients after PCI. Therapies to reduce stent thrombosis and heart failure appear to be most important in decreasing mortality in patients with STEMI or NSTEMI undergoing PCI.

  • 285.
    Fokkema, Marieke L
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    James, Stefan K
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Albertsson, Per
    Akerblom, Axel
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Calais, Fredrik
    Eriksson, Peter
    Jensen, Jens
    Nilsson, Tage
    de Smet, Bart J
    Sjögren, Iwar
    Thorvinger, Björn
    Lagerqvist, Bo
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Population Trends in Percutaneous Coronary Intervention: 20 Year Results from the SCAAR (Swedish Coronary Angiography and Angioplasty Registry)2013In: Journal of the American College of Cardiology, ISSN 0735-1097, E-ISSN 1558-3597, Vol. 61, no 12, p. 1222-1230Article in journal (Refereed)
    Abstract [en]

    OBJECTIVES:

    The aim of this study was to describe the characteristics and outcome of all consecutive patients treated with PCI in an unselected nation-wide cohort over the last 2 decades.

    BACKGROUND:

    Over the last 20 years, treatment with percutaneous coronary intervention (PCI) has evolved dramatically but the change in patient characteristics has not been well described.

    METHODS:

    We included all patients undergoing a PCI procedure for the first time between January 1990 and December 2010 from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). Patients were divided in different cohorts based on the year of the first PCI procedure.

    RESULTS:

    A total of 144,039 patients were included. The mean age increased from 60.1 (SD±9.9) years in 1990-1995 to 67.1 (±11.2) years in 2009-2010. The proportion of patients presenting with unstable coronary artery disease and STEMI increased from 27.4% and 6.2% to 47.7% and 32.5% respectively. Diabetes and multivessel disease were more often present in the later year cohorts. The 1-year mortality increased from 2.2% in 1990-1995 to 5.9% in 2009-2010, but after adjustment for age and indication a modest decrease was shown, mainly in STEMI patients.

    CONCLUSIONS:

    Characteristics of PCI patients have changed substantially over time reflecting the establishment of new evidence. The increasing age and proportion of patients undergoing PCI for acute coronary syndromes greatly influence outcome. The understanding of the changing patient characteristics is important for the translation of evidence to real-world clinical practice.

  • 286.
    Forbes, C. A.
    et al.
    Kleijnen Systemat Reviews Ltd, York, N Yorkshire, England..
    Deshpande, S.
    Kleijnen Systemat Reviews Ltd, York, N Yorkshire, England..
    Sorio-Vilela, F.
    Amgen Europe, Zug, Switzerland.;EEMEA, Zug, Switzerland..
    Kutikova, L.
    Amgen Europe GmbH, Zug, Switzerland..
    Duffy, S.
    Kleijnen Systemat Reviews Ltd, York, N Yorkshire, England..
    Gouni-Berthold, I
    Univ Cologne, Cologne, Germany..
    Hagström, Emil
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Comparison Of Methods To Measure Patient Adherence And Persistence With Pharmacological Therapy: A Systematic Review2017In: Value in Health, ISSN 1098-3015, E-ISSN 1524-4733, Vol. 20, no 9, p. A620-A620Article in journal (Other academic)
  • 287.
    Forbes, Carol A.
    et al.
    Kleijnen Systemat Reviews Ltd, York, N Yorkshire, England.
    Deshpande, Sohan
    Kleijnen Systemat Reviews Ltd, York, N Yorkshire, England.
    Sorio-Vilela, Francesc
    Amgen Europe GmbH, Global Hlth Econ, Zug, Switzerland.
    Kutikova, Lucie
    Amgen Europe GmbH, Global Hlth Econ, Zug, Switzerland.
    Duffy, Steven
    Kleijnen Systemat Reviews Ltd, York, N Yorkshire, England.
    Gouni-Berthold, Ioanna
    Univ Cologne, Polyclin Endocrinol Diabet & Prevent Med, Cologne, Germany.
    Hagström, Emil
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala Univ, Dept Med Sci, Uppsala Clin Res Ctr UCR, Uppsala, Sweden.
    A systematic literature review comparing methods for the measurement of patient persistence and adherence2018In: Current Medical Research and Opinion, ISSN 0300-7995, E-ISSN 1473-4877, Vol. 34, no 9, p. 1613-1625Article, review/survey (Refereed)
    Abstract [en]

    Objectives: A systematic literature review was conducted comparing different approaches estimating persistence and adherence in chronic diseases with polypharmacy of oral and subcutaneous treatments. Methods: This work followed published guidance on performing systematic reviews. Twelve electronic databases and grey literature sources were used to identify studies and guidelines for persistence and adherence of oral and subcutaneous therapies in hypercholesterolemia, type 2 diabetes, hypertension, osteoporosis and rheumatoid arthritis. Outcomes of interest of each persistence and adherence data collection and calculation method included pros: accurate, easy to use, inexpensive; and cons: inaccurate, difficult to use, expensive. Results: A total of 4158 records were retrieved up to March 2017. We included 16 observational studies, 5 systematic reviews and 7 guidelines, in patients with hypercholesterolemia (n=8), type 2 diabetes (n=4), hypertension (n=2), rheumatoid arthritis (n=1) and mixed patient populations (n=13). Pharmacy and medical records offer an accurate, easy and inexpensive data collection method. Pill count, medication event monitoring systems (MEMs), self-report questionnaires and observer report are easy to use. MEMS and biochemical monitoring tests can be expensive. Proportion of days covered (PDC) was recommended as a gold standard calculation method for long-term treatments. PDC avoids use of days' supply in calculation, hence is more accurate compared to medication possession ratio (MPR) to assess adherence to treatments in chronic diseases. Conclusions: Decisions on what method to use should be based on considerations of the route of medication administration, the resources available, setting and aim of the assessment. Combining different methods may provide wider insights into adherence and persistence, including patient behavior.

  • 288.
    Franchi, F.
    et al.
    Univ Florida, Coll Med Jacksonville, Jacksonville, FL USA..
    Angiolillo, D. J.
    Univ Florida, Coll Med Jacksonville, Jacksonville, FL USA..
    Ghukasyan, Tatevik
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Budaj, A.
    Grochowski Hosp, Postgrad Med Sch, Warsaw, Poland..
    Cornel, J. H.
    Med Ctr Alkmaar, Dept Cardiol, Alkmaar, Netherlands..
    Husted, S.
    Hosp Unit West, Dept Med, Herning, Denmark..
    Katus, H. A.
    Univ Klinikum Heidelberg, Med Klin, Heidelberg, Germany..
    Keltai, M.
    Semmelweis Univ, Hungarian Inst Cardiol, Budapest, Hungary..
    Kontny, F.
    Stavanger Univ Hosp, Dept Cardiol, Stavanger, Norway..
    Lewis, B. S.
    Lady Davis Carmel Med Ctr, Haifa, Israel..
    Storey, R. F.
    Univ Sheffield, Dept Cardiovasc Sci, Sheffield, S Yorkshire, England..
    Himmelmann, A.
    AstraZeneca Res & Dev, Gothenburg, Sweden..
    Wallentin, Lars
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    James, Stefan K.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Impact of diabetes mellitus and chronic kidney disease on cardiovascular outcomes and platelet P2Y12 receptor antagonist effects in patients with acute coronary syndromes: insights from the PLATO trial2016Conference paper (Refereed)
  • 289.
    Friberg, Leif
    et al.
    Department of Clinical Sciences at Danderyd Hospital, Karolinska Institute, Stockholm, Sweden.
    Oldgren, Jonas
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Efficacy and safety of non-vitamin K antagonist oral anticoagulants compared with warfarin in patients with atrial fibrillation2017In: Open heart, E-ISSN 2053-3624, Vol. 4, no 2, article id e000682Article in journal (Refereed)
    Abstract [en]

    AIMS: Non-vitamin K antagonist oral anticoagulants (NOACs) were in pivotal randomised controlled trials at least non-inferior to warfarin for stroke prevention in atrial fibrillation, but time in therapeutic range (TTR) for warfarin was lower (mean 55%-65%) than in Swedish general care where TTR is >70%. We compared efficacy and safety of NOACs and warfarin treatment for stroke prevention in Sweden.

    METHODS: Retrospective cohort study of all non-selected oral anticoagulation naïve atrial fibrillation patients with first prescription for NOACs or warfarin between December 2011 and December 2014, excluding patients with mitral stenosis or mechanical valvular prosthesis. Data were obtained from cross-linked national registers, propensity scores were used as continuous covariates, and associations between treatment and outcomes were evaluated by multivariable Cox regressions.

    RESULTS: -VASc points (mean) 3.38 vs 3.24, p<0.001, in NOAC and warfarin groups, respectively. HRs (95% CI) for NOACs versus warfarin were 1.04 (0.91-1.19) for all-cause stroke or systemic embolism, 1.16 (1.00-1.35) for ischaemic stroke, 0.85 (0.76-0.96) for major bleeding, 1.22 (1.01-1.46) for gastrointestinal bleeding, 0.60 (0.47-0.76) for intracranial haemorrhage and 0.89 (0.81-0.96) for all-cause mortality.

    CONCLUSION: In this large non-selected anticoagulation naïve Swedish atrial fibrillation cohort, the risks for all-cause stroke or systemic embolism were similar with NOACs and warfarin, but NOACs were associated with significantly lower risks of all-cause mortality, major bleeding and intracranial haemorrhage but higher risk of gastrointestinal bleeding. Better safety suggests NOACs as preferred treatment for patients with atrial fibrillation starting oral anticoagulation.

  • 290.
    Frigoli, Enrico
    et al.
    Univ Bern, Clin Trials Unit, Bern, Switzerland.
    Smits, Pieter
    Maasstad Hosp, Dept Cardiol, Rotterdam, Netherlands.
    Vranckx, Pascal
    Jessa Ziekenhuis, Hartcentrum Hasselt, Dept Cardiol & Crit Care Med, Hasselt, Belgium;Hasselt Univ, Fac Med & Life Sci, Hasselt, Belgium.
    Ozaki, Yokio
    Fujita Hlth Univ, Sch Med, Dept Cardiol, Toyoake, Aichi, Japan.
    Tijssen, Jan
    Univ Amsterdam, Acad Med Ctr, AMC Heartctr, Amsterdam, Netherlands.
    Juni, Peter
    Univ Toronto, St Michaels Hosp, Li Ka Shing Knowledge Inst, Appl Hlth Res Ctr, Toronto, ON, Canada.
    Morice, Marie-Claude
    CERC, Massy, France.
    Onuma, Yoshinobu
    Erasmus MC, Thorax Ctr, Rotterdam, Netherlands.
    Windecker, Stephan
    Bern Univ Hosp, Dept Cardiol, Bern, Switzerland.
    Frenk, Andre
    Bern Univ Hosp, Dept Cardiol, Bern, Switzerland.
    Spaulding, Christian
    Paris Descartes Univ, Hop Europeen Georges Pompidou, AP HP, INSERM,U 970,Sudden Death Expert Ctr,Cardiol Dept, Paris, France.
    Chevalier, Bernard
    Ramsay Gen Sante, Intervent Cardiol Dept, Inst Cardiovasc Paris Sud, Massy, France.
    Barbato, Emanuele
    Cardiovasc Res Ctr Aalst, Aalst, Belgium;Univ Federico II Naples, Dept Adv Biomed Sci, Div Cardiol, Naples, Italy.
    Tonino, Pim
    Catharina Hosp, Dept Cardiol, Eindhoven, Netherlands.
    Hildick-Smith, David
    Brighton & Sussex Univ Hosp NHSTrust, Brighton, E Sussex, England.
    Roffi, Marco
    Geneva Univ Hosp, Div Cardiol, Geneva, Switzerland.
    Kornowski, Ran
    Tel Aviv Univ, Sackler Sch Med, Rabin Med Ctr, Tel Aviv, Israel.
    Schultz, Carl
    Univ Western Australia, Royal Perth Hosp Campus, Dept Cardiol, Perth, WA, Australia.
    Lesiak, Maciej
    Univ Med Sci, Dept Cardiol 1, Poznan, Poland.
    Iniguez, Andres
    Hosp Alvaro Cunqueiro, Vigo, Spain.
    Colombo, Antonio
    IRCCS San Raffaele Sci Inst, Unit Cardiovasc Intervent, Milan, Italy.
    Alasnag, Mirvat
    King Fahad Armed Forces Hosp, Dept Cardiol, Jeddah, Saudi Arabia.
    Mullasari, Ajit
    Madras Med Mission, Chennai, Tamil Nadu, India.
    James, Stefan K
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Stankovic, Goran
    Univ Belgrade, Clin Ctr Serbia, Dept Cardiol, Belgrade, Serbia;Univ Belgrade, Fac Med, Belgrade, Serbia.
    Ong, Paul J. L.
    Tan Tock Seng Hosp, Singapore, Singapore.
    Rodriguez, Alfredo E.
    Otamendi Hosp, Buenos Aires Sch Med, Cardiac Unit, Cardiovasc Res Ctr CECI, Buenos Aires, DF, Argentina.
    Mahfoud, Felix
    Saarland Univ Hosp, Homburg, Germany.
    Bartunek, Jozef
    Bern Univ Hosp, Dept Cardiol, Bern, Switzerland.
    Moschovitis, Aris
    Bern Univ Hosp, Dept Cardiol, Bern, Switzerland.
    Laanmets, Peep
    North Estonia Med Ctr Fdn, Tallinn, Estonia.
    Leonardi, Sergio
    Fdn IRCCS Policlin San Matteo, Pavia, Italy.
    Heg, Dik
    Univ Bern, Clin Trials Unit, Bern, Switzerland.
    Sunnaker, Mikael
    Univ Bern, Clin Trials Unit, Bern, Switzerland.
    Valgimigli, Marco
    Bern Univ Hosp, Dept Cardiol, Bern, Switzerland.
    Design and rationale of the Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Standard DAPT Regimen (MASTER DAPT) Study2019In: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 209, p. 97-105Article in journal (Refereed)
    Abstract [en]

    Background The optimal duration of antiplatelet therapy in high-bleeding risk (HBR) patients with coronary artery disease treated with newer-generation drug-eluting bioresorbable polymer-coated stents remains unclear. Design MASTER DAPT (clinicaltrial.gov NCT03023020) is an investigator-initiated, open-label, multicenter, randomized controlled trial comparing an abbreviated versus a standard duration of antiplatelet therapy after bioresorbable polymer-coated Ultimaster (TANSEI) sirolimus-eluting stent implantation in approximately 4,300 HBR patients recruited from >= 100 interventional cardiology centers globally. After a mandatory 30-day dual-antiplatelet therapy (DAPT) run-in phase, patients are randomized to (a) a single antiplatelet regimen until study completion or up to 5 months in patients with clinically indicated oral anticoagulation (experimental 1-month DAPT group) or (b) continue DAPT for at least 5 months in patients without or 2 in patients with concomitant indication to oral anticoagulation, followed by a single antiplatelet regimen (standard antipkitelet regimen). With a final sample size of 4,300 patients, this study is powered to assess the noninferiority of the abbreviated antiplatelet regimen with respect to the net adverse clinical and major adverse cardiac and cerebral events composite end points and if satisfied for the superiority of abbreviated as compared to standard antiplatelet therapy duration in terms of major or clinically relevant nonmajor bleeding. Study end points will be adjudicated by a blinded Clinical Events Committee. Conclusions The MASTER DAPT study is the first randomized controlled trial aiming at ascertaining the optimal duration of antiplatelet therapy in HBR patients treated with sirolimus-eluting bioresorbable polymer-coated stent implantation.

  • 291. Frobert, Ole
    et al.
    Calais, Fredrik
    James, Stefan K.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Lagerqvist, Bo
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    ST-Elevation Myocardial Infarction, Thrombus Aspiration, and Different Invasive Strategies. A TASTE Trial Substudy2015In: Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease, ISSN 2047-9980, E-ISSN 2047-9980, Vol. 4, no 6, article id e001755Article in journal (Refereed)
    Abstract [en]

    Background-The clinical effect of thrombus aspiration in ST-elevation myocardial infarction may depend on the type of aspiration catheter and stenting technique. Methods and Results-The multicenter, prospective, randomized, open-label trial Thrombus Aspiration in ST-Elevation myocardial infarction in Scandinavia (TASTE) did not demonstrate a clinical benefit of thrombus aspiration compared to percutaneous coronary intervention alone. We assessed the effect of type of aspiration device, stent type, direct stenting, and postdilatation on outcomes at 1 year. There was no difference in all-cause mortality, between the 3 most frequently used aspiration catheters (Eliminate [Terumo] 5.4%, Export [Medtronic] 5.0%, Pronto [Vascular Solutions] 4.5%) in patients randomized to thrombus aspiration. There was no difference in mortality between directly stented patients randomized to thrombus aspiration compared to patients randomized to percutaneous coronary intervention only (risk ratio 1.08, 95% CI 0.70 to 1.67, P=0.73). Similarly, there was no difference in mortality between the 2 randomized groups for patients receiving drug-eluting stents (risk ratio 0.89, 95% CI 0.63 to 1.26, P=0.50) or for those treated with postdilation (risk ratio 0.72, 95% CI 0.49 to 1.07, P=0.11). Furthermore, there was no difference in rehospitalization for myocardial infarction or stent thrombosis between the randomized arms in any of the subgroups. Conclusions-In patients with ST-elevation myocardial infarction randomized to thrombus aspiration, the type of aspiration catheter did not affect outcome. Stent type, direct stenting, or postdilation did not affect outcome irrespective of treatment with thrombus aspiration and percutaneous coronary intervention or percutaneous coronary intervention alone.

  • 292.
    Frobert, Ole
    et al.
    Univ Orebro, Fac Hlth, Dept Cardiol, S-70185 Orebro, Sweden..
    James, Stefan K.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Coronary thrombus aspiration: a lesson for clinical medicine2016In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 387, no 10014, p. 97-98Article in journal (Other academic)
  • 293. Frobert, Ole
    et al.
    Lagerqvist, Bo
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Olivecrona, Goran K.
    Omerovic, Elmir
    Gudnason, Thorarinn
    Maeng, Michael
    Aasa, Mikael
    Angeras, Oskar
    Calais, Fredrik
    Danielewicz, Mikael
    Erlinge, David
    Hellsten, Lars
    Jensen, Ulf
    Johansson, Agneta C.
    Karegren, Amra
    Nilsson, Johan
    Robertson, Lotta
    Sandhall, Lennart
    Sjogren, Iwar
    Östlund, Ollie
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Harnek, Jan
    James, Stefan K.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Thrombus Aspiration during ST-Segment Elevation Myocardial Infarction2013In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 369, no 17, p. 1587-1597Article in journal (Refereed)
    Abstract [en]

    BackgroundThe clinical effect of routine intracoronary thrombus aspiration before primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI) is uncertain. We aimed to evaluate whether thrombus aspiration reduces mortality. MethodsWe conducted a multicenter, prospective, randomized, controlled, open-label clinical trial, with enrollment of patients from the national comprehensive Swedish Coronary Angiography and Angioplasty Registry (SCAAR) and end points evaluated through national registries. A total of 7244 patients with STEMI undergoing PCI were randomly assigned to manual thrombus aspiration followed by PCI or to PCI only. The primary end point was all-cause mortality at 30 days. ResultsNo patients were lost to follow-up. Death from any cause occurred in 2.8% of the patients in the thrombus-aspiration group (103 of 3621), as compared with 3.0% in the PCI-only group (110 of 3623) (hazard ratio, 0.94; 95% confidence interval [CI], 0.72 to 1.22; P=0.63). The rates of hospitalization for recurrent myocardial infarction at 30 days were 0.5% and 0.9% in the two groups, respectively (hazard ratio, 0.61; 95% CI, 0.34 to 1.07; P=0.09), and the rates of stent thrombosis were 0.2% and 0.5%, respectively (hazard ratio, 0.47; 95% CI, 0.20 to 1.02; P=0.06). There were no significant differences between the groups with respect to the rate of stroke or neurologic complications at the time of discharge (P=0.87). The results were consistent across all major prespecified subgroups, including subgroups defined according to thrombus burden and coronary flow before PCI. ConclusionsRoutine thrombus aspiration before PCI as compared with PCI alone did not reduce 30-day mortality among patients with STEMI. (Funded by the Swedish Research Council and others; ClinicalTrials.gov number, NCT01093404.)

  • 294. Froebert, Ole
    et al.
    James, Stefan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Sarno, Giovanna
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Saleh, Nawzad
    Lagerqvist, Bo
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Effect of stent inflation pressure and post-dilatation on the outcome of coronary artery intervention: a report of more than 90 000 stent implantations2012In: Journal of the American College of Cardiology, ISSN 0735-1097, E-ISSN 1558-3597, Vol. 60, no 17, p. B177-B177Article in journal (Other academic)
  • 295.
    Frostfeldt, Gunnar
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Sörensen, Jens
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Clinical Physiology.
    Lindahl, Bertil
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Valind, Sven
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Clinical Physiology.
    Wallentin, Lars
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Development of myocardial microcirculation and metabolism in acute ST-elevation myocardial infarction evaluated with positron emission tomography2005In: Journal of Nuclear Cardiology, ISSN 1071-3581, E-ISSN 1532-6551, Vol. 12, no 1, p. 43-54Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Early reperfusion is an established therapeutic objective in acute myocardial infarction (MI). The relationship of regional myocardial microcirculation and metabolism toward outcome in acute human MI is not well known.

    METHODS AND RESULTS: In 8 patients, positron emission tomography (PET) was performed with oxygen 15-labeled water at 3 hours, 24 hours, and 3 weeks after the start of fibrinolytic treatment, with carbon 11 acetate at 3 hours and with fluorine 18 fluorodeoxyglucose at 24 hours and 3 weeks. Absolute quantification of perfusion and water-perfusable tissue fraction (PTF), metabolic activity, and substrate extraction in 4 regions of interest was performed. Coronary angiography was performed at 24 hours. Short-term outcome at 3 weeks was evaluated by contractile reserve with dobutamine stress echocardiography and lung water measurements with PET. Early regional perfusion, PTF, and extraction and utilization of oxygen and glucose decreased closer to the infarct region ( P < .001 for all). Infarct-related oxygen utilization and extraction of oxygen and glucose were closely related to outcome ( P < .01 for all). PTF improved significantly in the infarct-related regions over time in proportion to early oxygen extraction and utilization.

    CONCLUSIONS: This pilot study indicates that PET might be useful in the evaluation of treatment efficacy and that restoration of oxidative metabolism is more closely related to myocardial damage recovery than perfusion in the early phase after MI.

  • 296.
    Fröbert, Ole
    et al.
    Univ Orebro, Fac Hlth, Dept Cardiol, Sodra Grev Rosengatan, S-70185 Orebro, Sweden..
    Arevstrom, Lilith
    Univ Orebro, Fac Hlth, Dept Cardiol, Sodra Grev Rosengatan, S-70185 Orebro, Sweden..
    Calais, Fredrik
    Univ Orebro, Fac Hlth, Dept Cardiol, Sodra Grev Rosengatan, S-70185 Orebro, Sweden..
    James, Stefan K.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Lagerqvist, Bo
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Height and prognosis following percutaneous coronary intervention2016In: International Journal of Cardiology, ISSN 0167-5273, E-ISSN 1874-1754, Vol. 224, p. 188-190Article in journal (Refereed)
  • 297.
    Fröbert, Ole
    et al.
    Orebro Univ, Fac Hlth, Dept Cardiol, S-70185 Orebro, Sweden..
    Götberg, Matthias
    Univ Hosp Lund, Dept Cardiol, Lund, Sweden..
    Angerås, Oskar
    Sahlgrens Univ Hosp, Dept Cardiol, Gothenburg, Sweden..
    Jonasson, Lena
    Univ Hosp Linkoping, Dept Cardiol, Linkoping, Sweden..
    Erlinge, David
    Univ Hosp Lund, Dept Cardiol, Lund, Sweden..
    Engstrom, Thomas
    Univ Copenhagen, Dept Cardiol, Rigshosp, Copenhagen, Denmark..
    Persson, Jonas
    Karolinska Inst, Danderyd Univ Hosp, Dept Clin Sci, Stockholm, Sweden..
    Jensen, Svend E.
    Aalborg Univ Hosp, Dept Cardiol, Aalborg, Denmark..
    Omerovic, Elmir
    Sahlgrens Univ Hosp, Dept Cardiol, Gothenburg, Sweden..
    James, Stefan K
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Lagerqvist, Bo
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Nilsson, Johan
    Umea Univ, Dept Publ Hlth & Clin Med, Heart Ctr, Cardiol, Umea, Sweden..
    Kåregren, Amra
    Vesteras Cty Hosp, Dept Cardiol, Vasteras, Sweden..
    Moer, Rasmus
    Feiring Clin, Feiring, Norway..
    Yang, Cao
    Orebro Univ, Sch Med Sci, Clin Epidemiol & Biostat, Orebro, Sweden.;Karolinska Inst, Inst Evironmentol Med, Unit Biostat, Stockholm, Sweden..
    Agus, David B.
    Univ Southern Calif, Lawrence J Ellison Inst Transformat Med, Los Angeles, CA 90089 USA..
    Erglis, Andrejs
    Pauls Stradins Clin Univ Hosp, Latvian Ctr Cardiol, Riga, Latvia..
    Jensen, Lisette O.
    Odense Univ Hosp, Dept Cardiol, Odense, Denmark..
    Jakobsen, Lars
    Aarhus Univ Hosp, Dept Cardiol, Aarhus, Denmark..
    Christiansen, Evald H.
    Aarhus Univ Hosp, Dept Cardiol, Aarhus, Denmark..
    Pernow, John
    Karolinska Inst, Karolinska Univ Hosp, Dept Med, Cardiol Unit, Stockholm, Sweden..
    Design and rationale for the Influenza vaccination After Myocardial Infarction (IAMI) trial. A registry-based randomized clinical trial2017In: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 189, p. 94-102Article in journal (Refereed)
    Abstract [en]

    Background: Registry studies and case-control studies have demonstrated that the risk of acute myocardial infarction (AMI) is increased following influenza infection. Small randomized trials, underpowered for clinical end points, indicate that future cardiovascular events can be reduced following influenza vaccination in patients with established cardiovascular disease. Influenza vaccination is recommended by international guidelines for patients with cardiovascular disease, but uptake is varying and vaccination is rarely prioritized during hospitalization for AMI.

    Methods/design: The Influenza vaccination After Myocardial Infarction (IAMI) trial is a double-blind, multicenter, prospective, registry-based, randomized, placebo-controlled, clinical trial. A total of 4,400 patients with ST-segment elevation myocardial infarction (STEMI) or non-STEMI undergoing coronary angiography will randomly be assigned either to in-hospital influenza vaccination or to placebo. Baseline information is collected from national heart disease registries, and follow-up will be performed using both registries and a structured telephone interview. The primary end point is a composite of time to all cause death, a new AMI, or stent thrombosis at 1 year.

    Implications: The IAMI trial is the largest randomized trial to date to evaluate the effect of in-hospital influenza vaccination on death and cardiovascular outcomes in patients with STEMI or non-STEMI. The trial is expected to provide highly relevant clinical data on the efficacy of influenza vaccine as secondary prevention after AMI.

  • 298. Fröbert, Ole
    et al.
    James, Stefan K.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Thrombus Aspiration during Myocardial Infarction REPLY2014In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 370, no 7, p. 675-676Article in journal (Refereed)
  • 299. Fröbert, Ole
    et al.
    Sarno, Giovanna
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences.
    James, Stefan K
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Saleh, Nawsad
    Lagerqvist, Bo
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Effect of stent inflation pressure and post-dilatation on the outcome of coronary artery intervention: A report of more than 90 000 stent implantations2013In: PLoS ONE, ISSN 1932-6203, E-ISSN 1932-6203, Vol. 8, no 2, p. e56348-Article in journal (Refereed)
    Abstract [en]

    BACKGROUND:

    Percutaneous coronary intervention (PCI) stent inflation pressure correlates to angiographic lumen improvement and stent expansion but the relation to outcome is not clarified. Using comprehensive registry data our aim was to evaluate how stent inflation pressure influences restenosis, stent thrombosis and death following PCI.

    METHODS:

    We evaluated all consecutive coronary stent implantations in Sweden during 46 months from 2008 using data from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). We used logistic regression and Cox proportional hazard modeling to estimate risk of outcomes with different balloon pressures.

    RESULTS:

    In total, 93 697 stents were eligible for analysis and divided into five different pressure interval groups: ≤15 atm, 16-17 atm, 18-19 atm, 20-21 atm and ≥22 atm. The risks of stent thrombosis and restenosis were significantly higher in the ≤15 atm, 18-19 atm and ≥22 atm groups (but not in the 16-17 atm group) compared to the 20-21 atm group. There were no differences in mortality. Post-dilatation was associated with a higher restenosis risk ratio (RR) of 1.22 (95% confidence interval (CI) 1.14-1.32, P<0.001) but stent thrombosis did not differ statistically between procedures with or without post-dilatation. The risk of death was lower following post-dilatation (RR 0.81 (CI 0.71-0.93) P = 0.003) and the difference compared to no post-dilatation was seen immediately after PCI.

    CONCLUSION:

    Our retrospective study of stent inflation pressure identified a possible biological pattern--the risks of stent thrombosis and of restenosis appeared to be higher with low and very high pressures. Post-dilatation might increase restenosis risk.

  • 300. Fröbert, Ole
    et al.
    Scherstén, Fredrik
    James, Stefan K
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Carlsson, Jörg
    Lagerqvist, Bo
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Long-term safety and efficacy of drug-eluting and bare metal stents in saphenous vein grafts2012In: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 164, no 1, p. 87-93Article in journal (Refereed)
    Abstract [en]

    BACKGROUND:

    Long-term safety and efficacy data of drug-eluting stents (DESs) in saphenous vein grafts (SVGs) are lacking. This study sought to compare the clinical outcomes of DES versus bare metal stents (BMS) in SVGs.

    METHODS:

    We studied all stent implantations in SVGs in Sweden during 74 months between 2005 and 2011 registered in the Swedish Coronary Angiography and Angioplasty Registry. We evaluated outcome in patients who received DES compared with those who received BMS after adjustments for differences in clinical, vessel, and lesion characteristics.

    RESULTS:

    Mean follow-up time was 3 years and 4 months. A total of 4,576 stents, implanted at 3,063 procedures, were included in the analysis of which 2,499 stents (54.6 %) were BMS and 2,077 (45.4%) were DES. The outcome analysis was based on 190 stent thromboses, 898 restenoses, and 523 deaths. The incidence of stent thrombosis did not differ between groups. When adjusted for baseline characteristics, including a propensity score for receiving DES, the incidence of restenosis was significantly lower with DES as compared with BMS (risk ratio 0.83, 95% CI 0.70-0.97, P = .019). There was a difference in mortality in the crude analysis between DES and BMS, and after multivariable adjustment, this difference remained statistically significant (risk ratio 0.80, CI 0.65-0.99, P = .038).

    CONCLUSIONS:

    The use of DES compared with BMS in SVGs was associated with a significantly lower adjusted incidence of restenosis and death in this large, national, all-encompassing propensity adjusted observational study.

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