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Atrial fibrillation

Bleeding versus thromboembolic protection in atrial fibrillation and coronary stent procedures.

18 Apr, 17 | by flee

Five to 8% of people undergoing percutaneous coronary intervention (PCI) also have atrial fibrillation (AF).  The optimal antiplatelet / anticoagulant regimen in these individuals remains unclear as stroke and stent thrombosis prevention need to be balanced against the risks of major bleeding.  The PIONEER AF-PCI trial (Open-Label, Randomized, Controlled, Multicenter Study Exploring Two Treatment Strategies of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects with Atrial Fibrillation who Undergo Percutaneous Coronary Intervention) randomized 2124 patients with AF who had undergone PCI to 1 of 3 arms: 15mg rivaroxaban + a P2Y12 inhibitor alone for 12 months, 2.5mg of twice daily rivaroxaban + a P2Y12 inhibitor and aspirin (DAPT) for 1, 6 or 12 months or warfarin + DAPT for 1, 6 or 12 months.  The predominant P2Y12 inhibitor was clopidogrel (approx. 90%). The primary endpoint was clinically significant bleeding while efficacy – both myocardial infarction and stroke were secondary end-points.  Both rivaroxaban arms demonstrated significant reductions in major bleeding relative to the warfarin arm (16.8% vs. 18.0% vs. 26.7%; P<0.001).  Furthermore, overall rates of stroke and myocardial infarction were similarly low across all sub-groups.

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