Apixaban for Stroke Prevention in Subclinical Atrial Fibrillation

作者：Jeff S. Healey, Renato D. Lópes, Christopher Bull Granger, Marco Alings, Léna Rivard, William F. McIntyre, Dan Atar, David H. Birnie, Giuseppe Boriani, A. John Camm, David Conen, Julia W. Erath, Michael Robert Gold, Stefan Hans Hohnloser, John H. Ip, Josef Kautzner, Valentina Kutyifa, Cecilia M. Linde, Philippe Mabo, Georges H. Mairesse, Juan Benezet Mazuecos, Jens Cosedis Nielsen, François Philippon, Marco Proietti, Christian Sticherling, Jorge A. Wong, David Jay Wright, Ignatius Gerardo E. Zarraga, Shelagh B. Coutts, Andrew J. Kaplan, Marta Pombo, Félix Ayala-Paredes, Lizhen Xu, Kim D. Simek, Sandra Nevills, Rajibul Islam Mian, Stuart J. Connolly · 发表于：New England Journal of Medicine · 年份：2023 · DOI：10.1056/nejmoa2310234 · 被引用次数：445 · 研究领域：Atrial Fibrillation Management and Outcomes、Intracerebral and Subarachnoid Hemorrhage Research、Acute Ischemic Stroke Management

BACKGROUND: Subclinical atrial fibrillation is short-lasting and asymptomatic and can usually be detected only by long-term continuous monitoring with pacemakers or defibrillators. Subclinical atrial fibrillation is associated with an increased risk of stroke by a factor of 2.5; however, treatment with oral anticoagulation is of uncertain benefit. METHODS: We conducted a trial involving patients with subclinical atrial fibrillation lasting 6 minutes to 24 hours. Patients were randomly assigned in a double-blind, double-dummy design to receive apixaban at a dose of 5 mg twice daily (2.5 mg twice daily when indicated) or aspirin at a dose of 81 mg daily. The trial medication was discontinued and anticoagulation started if subclinical atrial fibrillation lasting more than 24 hours or clinical atrial fibrillation developed. The primary efficacy outcome, stroke or systemic embolism, was assessed in the intention-to-treat population (all the patients who had undergone randomization); the primary safety outcome, major bleeding, was assessed in the on-treatment population (all the patients who had undergone randomization and received at least one dose of the assigned trial drug, with follow-up censored 5 days after permanent discontinuation of trial medication for any reason). RESULTS: -VASc score of 3.9±1.1 (scores range from 0 to 9, with higher scores indicating a higher risk of stroke); 36.1% of the patients were women. After a mean follow-up of 3.5±1.8 years, stroke or systemic e...