Association of international normalized ratio stability and bleeding outcomes among atrial fibrillation patients undergoing percutaneous coronary intervention: Insights from the PIONEER AF-PCI trial

Mathieu Kerneis, Megan K. Yee, Roxana Mehran, Tarek Nafee, Christoph Bode, Jonathan L. Halperin, Eric D. Peterson, Freek W.A. Verheugt, Peter Wildgoose, Martin Van Eickels, Gregory Y.H. Lip, Marc Cohen, Keith A.A. Fox, C. Michael Gibson

Research output: Contribution to journalArticlepeer-review

Abstract

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: A total of 2124 atrial fibrillation patients undergoing percutaneous coronary intervention were randomized to 3 groups: Rivaroxaban 15 mg od plus a P2Y12 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, P<0.05 for all). Rivaroxaban strategies were associated with a reduction in clinically significant bleeding compared with VKA regardless of the proportion of time spent with an INR >3 (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.

Original languageEnglish (US)
Article numbere007124
JournalCirculation: Cardiovascular Interventions
Volume12
Issue number2
DOIs
StatePublished - Feb 1 2019
Externally publishedYes

Keywords

  • atrial fibrillation
  • international normalized ratio
  • percutaneous coronary intervention
  • rivaroxaban
  • warfarin

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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