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Outcomes Among AF Patients Undergoing PCI
Study Questions:
What is the interaction between procedural access choice and lesion characteristics with bleeding and ischemic events among atrial fibrillation (AF) patients anticoagulated with rivaroxaban or warfarin following a percutaneous coronary intervention (PCI)?
Methods:
This was a subgroup analysis of the PIONEER AF-PCI trial, in which 2,124 patients were randomized to three groups: 1) rivaroxaban 15 mg once daily plus a P2Y12 inhibitor, 2) rivaroxaban 2.5 mg twice a day plus dual antiplatelet therapy (DAPT), and 3) dose-adjusted warfarin plus DAPT. The rates of clinically significant bleeding and major adverse cardiovascular events were compared between treatments stratified by subgroups of procedure type and lesion characteristics.
Results:
A reduction in bleeding events was seen with use of either of the rivaroxaban regimens in subgroups of radial versus femoral arterial access and by vascular closure device use. Similarly, when various lesion characteristics were considered (e.g., urgency of revascularization, location of culprit artery, presence of bifurcation lesion, presence of thrombus, type, and length of stent, or number of stents), there was no difference in the treatment effect of rivaroxaban on major adverse cardiovascular events.
Conclusions:
Among patients with AF who underwent PCI, rivaroxaban-based therapy was superior to warfarin plus DAPT in reducing bleeding outcomes regardless of the complexity of coronary artery disease or arterial access during the index coronary revascularization.
Perspective:
The PIONEER AF-PCI and RE-DUAL trials have clarified an approach to continuing novel oral anticoagulation therapy after PCI in patients with AF. The comparator arm in this study was warfarin plus DAPT, and it remains unclear if there would be a similar magnitude of reduction in bleeding if a combination of clopidogrel + warfarin was used instead of continuing DAPT in the warfarin arm. Nevertheless, the consistent benefit seen in all of the subgroups clearly establishes the safety of using rivaroxaban in this population.
Keywords: Anticoagulants, Arrhythmias, Cardiac, Atrial Fibrillation, Coronary Artery Disease, Hemorrhage, Myocardial Ischemia, Myocardial Revascularization, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Stents, Thrombosis, Vascular Closure Devices, Warfarin
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