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.

Practice-derived data on non-vitamin K antagonist oral anticoagulant therapy to complement observations from randomized trials

“… 59 That indicates that NOACs, mainly edoxaban and apixaban are safe and effective also in patients with AF and prior BPV replacement or valve repair. 60 , 61 …”

Intracardiac thrombus in a patient with mitral bioprosthesis and atrial fibrillation treated with direct oral anticoaugulant

“…It showed not significant differences between the 2 anticoagulants both in terms of efficacy and safety. [ 14 ]…”

“A Tale of Two Cities”: Anticoagulation Management in Patients with Atrial Fibrillation and Prosthetic Valves in the Era of Direct Oral Anticoagulants

“…Guimaraes at al. [27] have recently explored the efficacy and safety of apixaban versus warfarin in patients with AF and prior BPV replacement or valve repair, analyzing the data obtained from patients enrolled in the apixaban pivotal trial (ARISTOTLE). Of more than 18,000 patients enrolled, only 0.6% (104 patients, n = 76 aortic, n = 23 mitral and n = 5 aortic and mitral) had a history of BPV replacement: 55 were randomized to apixaban and 49 to warfarin.…”