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

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...

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Published in:Clinical cardiology (Mahwah, N.J.) Vol. 42; no. 5; pp. 568 - 571
Main Authors: Guimarães, Patricia O., Pokorney, Sean D., Lopes, Renato D., Wojdyla, Daniel M., Gersh, Bernard J., Giczewska, Anna, Carnicelli, Anthony, Lewis, Basil S., Hanna, Michael, Wallentin, Lars, Vinereanu, Dragos, Alexander, John H., Granger, Christopher B.
Format: Journal Article
Language:English
Published: New York Wiley Periodicals, Inc 01.05.2019
John Wiley & Sons, Inc
Subjects:
Aged
Anticoagulants
Anticoagulants - adverse effects
Anticoagulants - therapeutic use
apixaban
atrial fibrillation
Atrial Fibrillation - complications
Atrial Fibrillation - diagnosis
Atrial Fibrillation - drug therapy
Bioprosthesis
bioprosthetic valves
Cardiac arrhythmia
Catheters
Clinical Investigations
Factor Xa Inhibitors - adverse effects
Factor Xa Inhibitors - therapeutic use
Female
Heart Valve Prosthesis
Heart Valve Prosthesis Implantation - adverse effects
Heart Valve Prosthesis Implantation - instrumentation
Heart Valves - surgery
Hemorrhage - chemically induced
Humans
Male
Middle Aged
Pyrazoles - adverse effects
Pyrazoles - therapeutic use
Pyridones - adverse effects
Pyridones - therapeutic use
Risk Factors
Stroke - diagnosis
Stroke - etiology
Stroke - prevention & control
Time Factors
Treatment Outcome
valve repair
Warfarin - adverse effects
Warfarin - therapeutic use
bioprosthetic valves
atrial fibrillation
apixaban
valve repair
ISSN:0160-9289, 1932-8737, 1932-8737
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Summary: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.
Bibliography:Funding information
Bristol‐Myers Squibb; Pfizer
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These authors take responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.
Michael Hanna is the Employee of Bristol‐Myers Squibb at the time of study conduct.
Funding information Bristol‐Myers Squibb; Pfizer
ISSN:0160-9289
1932-8737
1932-8737
DOI:10.1002/clc.23178