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Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation.
Baim Institute for Clinical Research, USA; Brigham and Women’s Hospital, Heart and Vascular Center, USA; Harvard Medical School, USA.
Brigham and Women’s Hospital, Heart and Vascular Center, USA; Harvard Medical School, USA.
Uppsala Clinical Research Center and Department of Medical Sciences, Uppsala University, Uppsala, Sweden.
Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, UK.
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2017 (English)In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 377, no 16, p. 1513-1524Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: Triple antithrombotic therapy with warfarin plus two antiplatelet agents is the standard of care after percutaneous coronary intervention (PCI) for patients with atrial fibrillation, but this therapy is associated with a high risk of bleeding.

METHODS: inhibitor (clopidogrel or ticagrelor) and no aspirin (110-mg and 150-mg dual-therapy groups). Outside the United States, elderly patients (≥80 years of age; ≥70 years of age in Japan) were randomly assigned to the 110-mg dual-therapy group or the triple-therapy group. The primary end point was a major or clinically relevant nonmajor bleeding event during follow-up (mean follow-up, 14 months). The trial also tested for the noninferiority of dual therapy with dabigatran (both doses combined) to triple therapy with warfarin with respect to the incidence of a composite efficacy end point of thromboembolic events (myocardial infarction, stroke, or systemic embolism), death, or unplanned revascularization.

RESULTS: The incidence of the primary end point was 15.4% in the 110-mg dual-therapy group as compared with 26.9% in the triple-therapy group (hazard ratio, 0.52; 95% confidence interval [CI], 0.42 to 0.63; P<0.001 for noninferiority; P<0.001 for superiority) and 20.2% in the 150-mg dual-therapy group as compared with 25.7% in the corresponding triple-therapy group, which did not include elderly patients outside the United States (hazard ratio, 0.72; 95% CI, 0.58 to 0.88; P<0.001 for noninferiority). The incidence of the composite efficacy end point was 13.7% in the two dual-therapy groups combined as compared with 13.4% in the triple-therapy group (hazard ratio, 1.04; 95% CI, 0.84 to 1.29; P=0.005 for noninferiority). The rate of serious adverse events did not differ significantly among the groups.

CONCLUSIONS: inhibitor, and aspirin. Dual therapy was noninferior to triple therapy with respect to the risk of thromboembolic events. (Funded by Boehringer Ingelheim; RE-DUAL PCI ClinicalTrials.gov number, NCT02164864)

Place, publisher, year, edition, pages
Massachusetts Medical Society , 2017. Vol. 377, no 16, p. 1513-1524
National Category
Cardiac and Cardiovascular Systems
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URN: urn:nbn:se:liu:diva-145511DOI: 10.1056/NEJMoa1708454ISI: 000413243900005PubMedID: 28844193OAI: oai:DiVA.org:liu-145511DiVA, id: diva2:1187388
Available from: 2018-03-04 Created: 2018-03-04 Last updated: 2018-07-03

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Division of Cardiovascular MedicineFaculty of Medicine and Health SciencesDepartment of Cardiology in Linköping
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