Rivaroxaban-based therapy was superior to warfarin plus dual antiplatelet therapy in lowering clinically significant bleeding regardless of INR stability (HR ranges 0.42-0.76; P<0.05).
RCT (n=2,124)
Open-label
Randomized
Yes
Do rivaroxaban-based strategies reduce clinically significant bleeding compared to warfarin plus dual antiplatelet therapy regardless of INR stability in atrial fibrillation patients undergoing percutaneous coronary intervention?
Rivaroxaban-based antithrombotic strategies reduce bleeding compared to warfarin plus DAPT in AF patients undergoing PCI, even when warfarin is well-managed with high time in therapeutic range.
Effect estimate: HR ranges 0.42-0.76
p-value: p=<0.05
BACKGROUND: Among atrial fibrillation patients undergoing percutaneous coronary intervention enrolled in PIONEER AF-PCI (An 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), it is unclear if the observed reduction in bleeding events with rivaroxaban regimens is consistent across a range of the international normalized ratio (INR) among subjects administrated Vitamin K antagonist (VKA)-triple therapy. This analysis compares the occurrence of clinically significant bleeding between rivaroxaban and VKA strategies, according to INR stability of subjects administrated VKA. METHODS AND RESULTS: inhibitor (group 1, n=709); rivaroxaban 2.5 mg bid plus dual antiplatelet therapy (group 2, n=709); and warfarin plus dual antiplatelet therapy (group 3, n=706). Subjects assigned to the VKA group were stratified according to time in therapeutic range and time spent with an INR >3. Kaplan-Meier estimates were calculated for clinically significant bleeding through 1 year and hazard ratios were derived using Cox Proportional Hazards models. Among group 3, 93.4% of the participants had a time in therapeutic range available (mean time in therapeutic range=65.0±24.8%). Both groups 1 and 2 were associated with a reduction in clinically significant bleeding compared with subjects in group 3, regardless of the time in therapeutic range (hazard ratio ranges=0.53-0.71 and 0.57-0.76; respectively, P3 (hazard ratio ranges=0.59-0.67 and 0.42-0.69; P<0.05 for all). CONCLUSIONS: Among atrial fibrillation patients undergoing percutaneous coronary intervention, rivaroxaban-based therapy was superior to warfarin plus dual antiplatelet therapy in lowering bleeding outcomes regardless of the INR stability. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01830543.
Kernéis et al. (2019) conducted an RCT in Atrial fibrillation undergoing percutaneous coronary intervention (n=2,124). Rivaroxaban vs. Warfarin plus dual antiplatelet therapy was evaluated on Clinically significant bleeding (HR ranges 0.42-0.76, p=<0.05). Rivaroxaban-based therapy was superior to warfarin plus dual antiplatelet therapy in lowering clinically significant bleeding regardless of INR stability (HR ranges 0.42-0.76; P<0.05).