Efficacy and safety of apixaban vs warfarin in patients with atrial fibrillation and prior bioprosthetic valve replacement or valve repair: Insights from the ARISTOTLE trial

Abstract

Background: The optimal anticoagulation strategy for patients with atrial fibrillation (AF) and bioprosthetic valve (BPV) replacement or native valve repair remains uncertain.

Hypothesis: We evaluated the safety and efficacy of apixaban vs warfarin in patients with AF and a history of BPV replacement or native valve repair.

Methods: Using data from Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) (n = 18 201), a randomized trial comparing apixaban with warfarin in patients with AF, we analyzed the subgroup of patients (n = 251) with prior valve surgery. We contacted sites by telephone to obtain additional data about prior valve surgery. Full data were available for 156 patients. The primary efficacy endpoint was stroke/systemic embolism. The primary safety endpoint was major bleeding. Treatment groups were compared using a Cox regression model.

Results: In ARISTOTLE, 104 (0.6%) patients had a history of BPV replacement (n = 73 [aortic], n = 26 [mitral], n = 5 [mitral and aortic]) and 52 (0.3%) had a history of valve repair (n = 50 [mitral], n = 2 [aortic]). Among patients with BPVs, 55 were randomized to apixaban and 49 to warfarin. Among those with a history of native valve repair, 32 were randomized to apixaban and 20 to warfarin. Overall clinical event rates were low, with no significant differences between apixaban and warfarin for any outcomes.

Conclusions: In patients with AF and a history of BPV replacement or repair, the safety and efficacy of apixaban compared with warfarin was consistent with results from ARISTOTLE. These data suggest that apixaban may be reasonable for patients with BPVs or prior valve repair, though future larger randomized trials are needed. CLINICALTRIALS.GOV: NCT00412984.

Keywords: apixaban; atrial fibrillation; bioprosthetic valves; valve repair.

Conflict of interest statement

Guimarães, Wojdyla, Giczewska, Carnicelli: None. Pokorney: Research grants: Food and Drug Administration, Bristol‐Myers Squibb, Pfizer, Janssen, Gilead, Boston Scientific; Consultant/advisory board: Boston Scientific and Medtronic. Lopes: Research grants: Bristol‐Myers Squibb, GlaxoSmithKline, Medtronic, Pfizer; Consultant: Bayer, Boehringer Ingelheim, Bristol‐Myers Squibb, Daiichi Sankyo, GlaxoSmithKline, Medtronic, Merck, Pfizer, Portola. Gersh: Consultant: Xenon Pharmaceuticals; Data safety monitoring board: Armetheon, Baxter, CardioVascular Research Foundation, Janssen, Medtronic, Mount Sinai St. Luke's, Teva Pharmaceuticals, Thrombosis Research Institute; Other: Boston Scientific, Cipla Limited, Janssen, St. Jude Medical. Lewis: Institutional research grants: Bristol‐Myers Squibb, Pfizer, Bayer Healthcare; Consultant: Bristol‐Myers Squibb, Pfizer.

Hanna: Employee of Bristol‐Myers Squibb at the time of study conduct. Wallentin: Research grants: AstraZeneca, Boehringer Ingelheim, Bristol‐Myers Squibb/Pfizer, GlaxoSmithKline, Merck/Schering‐Plow, Roche Diagnostics; Consultant: Abbott, AstraZeneca, Boehringer Ingelheim, Bristol‐Myers Squibb/Pfizer, GlaxoSmithKline. Vinereanu: Research grants: Bristol‐Myers Squibb/Pfizer, Boehringer Ingelheim, Janssen/Bayer, Daiichi Sankyo, Novartis, Servier; Consultant: Bristol‐Myers Squibb/Pfizer, Boehringer Ingelheim, Janssen/Bayer, Novartis, and Servier. Alexander: Research grants: AstraZeneca, Bristol‐Myers Squibb, Boehringer Ingelheim, CryoLife, CSL Behring, US Food and Drug Administration, National Institutes of Health, Sanofi, Tenax Therapeutics; Consultant: Cempra, CryoLife, CSL Behring, Merck, Novo Nordisk, Pfizer, Portola, VA Cooperative Studies, VasoPrep Surgical, Zafgen. Granger: Research grants: Armetheon, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol‐Myers Squibb, Daiichi Sankyo, GlaxoSmithKline, US Food and Drug Administration, Janssen, Medtronic Foundation, Novartis, Pfizer; Consultant: Abbvie, Armetheon, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol‐Myers Squibb, Daiichi Sankyo, Gilead Sciences, Janssen, Medscape, Medtronic, Merck, National Institutes of Health, Novartis, Pfizer, Sirtex, Verseon.

© 2019 The Authors. Clinical Cardiology published by Wiley Periodicals, Inc.