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Dabigatran dual therapy with ticagrelor or clopidogrel after percutaneous coronary intervention in atrial fibrillation patients with or without acute coronary syndrome: a subgroup analysis from the RE-DUAL PCI trial
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.ORCID iD: 0000-0002-9969-3921
Univ Paris Diderot, FACT, F CRIN Network, INSERM U 1148, F-75018 Paris, France;Hop Bichat Assistance Publ, F-75018 Paris, France;Royal Brompton Hosp, Imperial Coll, Sydney St, London SW3 6NP, England.
Goethe Univ Frankfurt, Dept Med, Div Cardiol, Theodor Stern Kai 7, DE-60590 Frankfurt, Germany.
Univ Birmingham, Inst Cardiovasc Sci, Birmingham B15 2TT, W Midlands, England;Univ Liverpool, Liverpool Ctr Cardiovasc Sci, Liverpool Heart & Chest Hosp, Liverpool L69 3BX, Merseyside, England;Dept Clin Med, Aalborg Thrombosis Res Unit, Sondre Skovvej 15, DK-9000 Aalborg, Denmark.
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2019 (English)In: European Heart Journal, ISSN 0195-668X, E-ISSN 1522-9645, Vol. 40, no 19, p. 1553-1562Article in journal (Refereed) Published
Abstract [en]

Aims

After percutaneous coronary intervention (PCI) in patients with atrial fibrillation, safety and efficacy with dabigatran dual therapy were evaluated in pre-specified subgroups of patients undergoing PCI due to acute coronary syndrome (ACS) or elective PCI, and those receiving ticagrelor or clopidogrel treatment.

Methods and results

In the RE-DUAL PCI trial, 2725 patients were randomized to dabigatran 110 mg or 150 mg with P2Y12 inhibitor, or warfarin with P2Y12 inhibitor and aspirin. Mean follow-up was 14 months, 50.5% had ACS, and 12% received ticagrelor. The risk of the primary endpoint, major or clinically relevant non-major bleeding event, was reduced with both dabigatran dual therapies vs. warfarin triple therapy in patients with ACS [hazard ratio (95% confidence interval), 0.47 (0.35-0.63) for 110 mg and 0.67 (0.50-0.90) for 150 mg]; elective PCI [0.57 (0.43-0.76) for 110 mg and 0.76 (0.56-1.03) for 150 mg]; receiving ticagrelor [0.46 (0.28-0.76) for 110 mg and 0.59 (0.34-1.04) for 150 mg]; or clopidogrel [0.51 (0.41-0.64) for 110 mg and 0.73 (0.58-0.91) for 150 mg], all interaction P-values >0.10. Overall, dabigatran dual therapy was comparable to warfarin triple therapy for the composite endpoint of death, myocardial infarction, stroke, systemic embolism, or unplanned revascularization, with minor variations across the subgroups, all interaction P-values >0.10.

Conclusion

The benefits of both dabigatran 110 mg and 150 mg dual therapy compared with warfarin triple therapy in reducing bleeding risks were consistent across subgroups of patients with or without ACS, and patients treated with ticagrelor or clopidogrel.

Place, publisher, year, edition, pages
2019. Vol. 40, no 19, p. 1553-1562
Keywords [en]
Atrial fibrillation, Acute coronary syndrome, Coronary artery disease, Percutaneous coronary intervention, Oral anticoagulants, P2Y12 inhibitors
National Category
Cardiac and Cardiovascular Systems
Identifiers
URN: urn:nbn:se:uu:diva-396559DOI: 10.1093/eurheartj/ehz059ISI: 000490018900017PubMedID: 30793734OAI: oai:DiVA.org:uu-396559DiVA, id: diva2:1368342
Available from: 2019-11-06 Created: 2019-11-06 Last updated: 2019-11-06Bibliographically approved

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