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)
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Abbreviations
- AF:
-
Atrial fibrillation
- DAPT:
-
Dual antiplatelet therapy
- PCI:
-
Percutaneous coronary intervention
- PIONEER AF-PCI:
-
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
- TIMI:
-
Thrombolysis in myocardial infarction
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Funding
The study was funded by Janssen Scientific Affairs and Bayer.
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All authors have received research grant support from Janssen Scientific Affairs, LLC, and Bayer, the sponsors of the study. Dr. Wildgoose is an employee of Janssen, a Johnson & Johnson affiliate. Dr. van Eickels is an employee of Bayer AG. Drs. Halperin and Lip have received consulting fees from Janssen. Dr Cohen is part of the Janssen speakers bureau and has received research grant support and advisory board honoraria. Dr. Gibson has received consulting fees from Janssen Scientific Affairs, LLC, and Bayer.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
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Informed consent was obtained from all individual participants included in the study.
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Chi, G., Yee, M.K., Kalayci, A. et al. Total bleeding with rivaroxaban versus warfarin in patients with atrial fibrillation receiving antiplatelet therapy after percutaneous coronary intervention. J Thromb Thrombolysis 46, 346–350 (2018). https://doi.org/10.1007/s11239-018-1703-5
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DOI: https://doi.org/10.1007/s11239-018-1703-5