Total bleeding with rivaroxaban versus warfarin in patients with atrial fibrillation receiving antiplatelet therapy after percutaneous coronary intervention

Gerald Chi, Megan K. Yee, Arzu Kalayci, Mathieu Kerneis, Fahad AlKhalfan, Roxana Mehran, Christoph Bode, Jonathan L. Halperin, Freek W.A. Verheugt, Peter Wildgoose, Martin van Eickels, Gregory Y.H. Lip, Marc Cohen, Eric D. Peterson, Keith A.A. Fox, C. Michael Gibson

Research output: Contribution to journalArticlepeer-review

Abstract

Among atrial fibrillation (AF) patients undergoing percutaneous coronary intervention (PCI), rivaroxaban with background antiplatelet therapy significantly reduced the first occurrence of bleeding compared to triple therapy with warfarin. This study hypothesized that total bleeding events, including those beyond the first event, would be reduced with rivaroxaban-based regimens. In the PIONEER AF-PCI trial, 2099 patients in the modified intention-to-treat population were randomized to three groups and followed for 12 months: (1) rivaroxaban 15 mg once daily plus a P2Y12 inhibitor (N = 696); (2) rivaroxaban 2.5 mg twice daily plus dual antiplatelet therapy (DAPT) (N = 706); and (3) dose-adjusted warfarin plus DAPT (N = 697). Descriptive statistics for the number of subjects who experienced one or more bleeding events were calculated. The total number of bleeding events was compared across treatment groups using the Wei, Lin, and Weissfeld method. A total of 514 and 439 events of clinically significant bleeding and bleeding requiring medical attention occurred throughout the study. Compared to triple therapy with warfarin, rivaroxaban-based regimen was associated with a reduction in total events of clinically significant bleeding (Group 1 vs. Group 3: HR 0.64 [95% CI 0.49–0.85], p < 0.001, NNT = 11; Group 2 vs. Group 3: HR 0.62 [95% CI 0.48–0.80], p < 0.001, NNT = 10). Similarly, rivaroxaban reduced the total bleeding events requiring medical attention (Group 1 vs. Group 3: HR 0.66 [95% CI 0.49–0.89], p < 0.001, NNT = 14; Group 2 vs. Group 3: HR 0.64 [95% CI 0.48–0.85], p = 0.002, NNT = 13). Rivaroxaban-based regimen reduced the total bleeding events compared with VKA-based triple therapy in stented AF patients. One clinically significant bleeding event could be prevented with rivaroxaban use for every 10–11 patients treated, and one bleeding requiring medical attention could be prevented with rivaroxaban for every 13–14 patients treated. These data provide evidence that total bleeding events, including those beyond the first event, are reduced with rivaroxaban-based antithrombotic regimens. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01830543 (PIONEER AF-PCI).

Original languageEnglish (US)
Pages (from-to)346-350
Number of pages5
JournalJournal of Thrombosis and Thrombolysis
Volume46
Issue number3
DOIs
StatePublished - Oct 1 2018
Externally publishedYes

Keywords

  • Anticoagulant
  • Atrial fibrillation
  • Bleeding
  • Percutaneous coronary intervention
  • Rivaroxaban

ASJC Scopus subject areas

  • Hematology
  • Cardiology and Cardiovascular Medicine

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