Transition of patients from blinded study drug to open-label anticoagulation: the ENGAGE AF-TIMI 48 trial.

作者: Christian T. Ruff , Robert P. Giugliano , Eugene Braunwald , Michele Mercuri , Valentin Curt

DOI: 10.1016/J.JACC.2014.05.028

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摘要: Abstract Background At the end of 2 previous trials, an excess stroke and bleeding was observed in patients with AF randomized to a new oral anticoagulant (NOAC) who transitioned vitamin K antagonist (VKA). Objectives The ENGAGE AF–TIMI 48 (Effective Anticoagulation Factor Xa Next Generation Atrial Fibrillation—Thrombolysis Myocardial Infarction 48) trial compared once-daily edoxaban warfarin for prevention AF. An end-of-trial transition plan developed minimize risks due inadequate anticoagulation from excessive during this critical period. Methods All on blinded study drug at trial’s conclusion were included analysis. In pre-specified analyses, stroke, bleeding, death that occurred through 30 days after visit stratified by treatment allocation open-label selected post-trial. Results Of 13,642 taking trial, 9,304 (68.2%) VKA 4,258 (31.2%) NOAC. There 21 strokes evenly distributed across 3 arms: 7 (1.90%/year), high dose (1.89%/year), low (1.85%/year). Major also similar 11 (2.98%/year), 10 (2.69%/year), 18 (4.76%/year). VKA, 85% had least 1 INR ≥2 by day 14 99% day 30. Conclusions protected thrombotic bleeding events should be helpful clinical practice when are between anticoagulants. (Global Study Assess Safety Effectiveness Edoxaban [DU-176b] vs Standard Practice Dosing With Warfarin Patients Fibrillation [EngageAFTIMI48];  NCT00781391 )

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