Apixaban versus warfarin in patients with atrial fibrillation according to prior warfarin use: Results from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation trial - 07/09/13
, Lars Wallentin, MD, PhD b, Renato D. Lopes, MD, PhD c, Laine Thomas, PhD c, John H. Alexander, MD, MHS c, Elaine M. Hylek, MD, MPH d, Jack Ansell, MD e, Michael Hanna, MD f, Fernando Lanas, MD g, Greg Flaker, MD h, Patrick Commerford, MB, ChB i, Denis Xavier, MD j, Dragos Vinereanu, MD, PhD k, Hongqiu Yang, PhD c, Christopher B. Granger, MD cRésumé |
Background |
Patients with atrial fibrillation who are vitamin K antagonist (VKA)-naive may have a higher risk of thrombosis and/or bleeding than VKA-experienced patients.
Methods and results |
Using data from ARISTOTLE, we assessed baseline characteristics and the treatment effect of apixaban versus warfarin in the VKA-naive and VKA-experienced cohorts. We compared rates of study drug discontinuation and time-in-therapeutic range. Overall, 7,800 (43%) were VKA naive, and 10,401 were VKA experienced. At baseline, both groups were similar with respect to age and congestive heart failure, hypertension, age, diabetes, stroke score (CHADS2). Fewer VKA-naive patients had a history of prior stroke (18% vs 21%) or prior bleeding (10% vs 22%) and were more often female (39% vs 33%). The effect of apixaban on the primary efficacy and safety outcomes was similar in VKA-naive (stroke/systemic embolism: hazard ratio [HR] 0.86, 95% CI 0.67-1.11 and major bleeding: HR 0.73, 95% CI 0.59-0.91) and VKA-experienced populations (stroke/systemic embolism: HR 0.73, 95% CI 0.57-0.95, P value for interaction = 0.39 and major bleeding: HR 0.66, 95% CI 0.55-0.80, P value for interaction = 0.50). Permanent study drug discontinuation was numerically less likely in patients receiving apixaban whether they were VKA naive (HR for discontinuation: 0.87, 95% CI 0.79-0.95) or VKA experienced (HR for discontinuation: 0.93, 95% CI 0.85-1.02). Among patients receiving warfarin, the mean/median times in therapeutic range were lower in the VKA-naive group (VKA-naive: 57.5/61.4, VKA-experienced: 66.0/69.1, P < .001).
Conclusion |
The treatment effects of apixaban (vs warfarin) were not modified by VKA naivety. The rates of stroke/systemic embolism and major bleeding were numerically lower among the patients assigned to apixaban, irrespective of prior VKA use.
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| Presented at the 2012 American Heart Association Scientific Sessions, November 3 to 7, in Los Angeles, CA. |
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| Journal subject codes: [185] Other anticoagulants; [70] Anticoagulants; [5] Arrhythmias, clinical electrophysiology, drugs. |
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| Clinical Trial Registration: NCT00412984. |
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| William G. Stevenson, MD, served as guest editor for this article. |
Vol 166 - N° 3
P. 549-558 - septembre 2013 Retour au numéro
Article précédent
- High-sensitive cardiac troponin T and its relations to cardiovascular risk factors, morbidity, and mortality in elderly men
- Kai M. Eggers, Jinan Al-Shakarchi, Lars Berglund, Bertil Lindahl, Agneta Siegbahn, Lars Wallentin, Björn Zethelius
- Documentation of study medication dispensing in a prospective large randomized clinical trial: Experiences from the ARISTOTLE Trial
- John H. Alexander, Elliott Levy, Jack Lawrence, Michael Hanna, Anthony P. Waclawski, Junyuan Wang, Robert M. Califf, Lars Wallentin, Christopher B. Granger
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