Abstract | BACKGROUND: OBJECTIVES: METHODS: All patients on the blinded study drug at the trial's conclusion were included in this analysis. In pre-specified analyses, stroke, bleeding, and death that occurred through 30 days after the end-of-trial visit were stratified by randomized treatment allocation and open-label anticoagulant selected post-trial. RESULTS: Of the 13,642 patients taking the blinded study drug at the end of the trial, 9,304 (68.2%) were transitioned to open-label VKA and 4,258 patients (31.2%) to an NOAC. There were 21 strokes evenly distributed across the 3 randomized treatment arms: warfarin 7 (1.90%/year), edoxaban high dose 7 (1.89%/year), edoxaban low dose 7 (1.85%/year). Major bleeding was also similar across the 3 treatment arms: warfarin 11 (2.98%/year), edoxaban high dose 10 (2.69%/year), edoxaban low dose 18 (4.76%/year). In patients transitioned to VKA, 85% of patients had at least 1 INR ≥ 2 by day 14 after the transition and 99% by day 30. CONCLUSIONS: The ENGAGE AF-TIMI 48 transition plan protected patients from an excess of thrombotic and bleeding events and should be helpful in clinical practice when patients are transitioned between oral anticoagulants. (Global Study to Assess the Safety and Effectiveness of Edoxaban [DU-176b] vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation [EngageAFTIMI48]; NCT00781391).
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Authors | Christian T Ruff, Robert P Giugliano, Eugene Braunwald, Michele Mercuri, Valentin Curt, Joshua Betcher, Laura Grip, Abby L Cange, Andrea E Crompton, Sabina A Murphy, Naveen Deenadayalu, Elliott M Antman |
Journal | Journal of the American College of Cardiology
(J Am Coll Cardiol)
Vol. 64
Issue 6
Pg. 576-84
(Aug 12 2014)
ISSN: 1558-3597 [Electronic] United States |
PMID | 25104527
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Anticoagulants
- Pyridines
- Thiazoles
- Warfarin
- Factor Xa
- edoxaban
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Topics |
- Administration, Oral
- Aged
- Anticoagulants
(administration & dosage)
- Atrial Fibrillation
(diagnosis, drug therapy, epidemiology)
- Double-Blind Method
- Drug Substitution
(methods)
- Factor Xa
(administration & dosage)
- Female
- Humans
- Male
- Middle Aged
- Myocardial Infarction
(diagnosis, drug therapy, epidemiology)
- Pyridines
(administration & dosage)
- Thiazoles
(administration & dosage)
- Treatment Outcome
- Warfarin
(administration & dosage)
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