P6112Effect of procedure and lesion characteristics on bleeding and ischemic outcomes among atrial fibrillation patients undergoing percutaneous coronary intervention: results from the PIONEER AF-PCI trial

Abstract

Background: Among atrial fibrillation (AF) patients undergoing percutaneous coronary intervention (PCI), it remains unclear whether procedure or lesion characteristics would affect the safety or efficacy outcomes associated with antithrombotic therapy. Purpose: The study aimed to assess the interaction of procedure and lesion characteristics with bleeding and ischemic events among AF patients anticoagulated with rivaroxaban or warfarin. Methods: In the PIONEER AF‐PCI trial, 2,124 patients were randomized to three groups and followed for 12 months: 1) rivaroxaban (15 mg od) plus a single P2Y12 inhibitor (N=709); 2) rivaroxaban (2.5 mg bid) plus dual antiplatelet therapy (DAPT) (N=709); and 3) dose‐adjusted warfarin plus DAPT (N=706). Kaplan‐ Meier rates of clinically significant bleeding (a composite of TIMI major bleeding, minor bleeding, or bleeding requiring medical attention) and major adverse cardiovascular event (MACE) were compared between treatment stratified by subgroups of procedure and lesion characteristics. All events were adjudicated by an independent committee blinded to treatment assignment. Results: Compared to warfarin, both rivaroxaban doses consistently reduced clinically significant bleeding across subgroups of radial vs femoral arterial access and vascular closure device use. Treatment effect of both rivaroxaban doses on MACE did not vary significantly when stratified by ischemia‐driven revascularization, urgency of revascularization, location of culprit artery, presence of angiographic stenosis, presence of bifurcation lesion, presence of thrombus, type of stent, length of stent, or number of stents (Interaction P>0.05 for all subgroups). Conclusions: Among AF patients undergoing stent placement anticoagulated with rivaroxaban or warfarin, there was no significant effect modification by procedure or lesion characteristics on clinically significant bleeding or major adverse cardiovascular event.