Low-dose warfarin with a novel mechanical aortic valve: Interim registry results at 5-year follow-up.

Autor:	Gerdisch MW; Department of Cardiothoracic Surgery, Franciscan Health, Indianapolis, Ind. Electronic address: mgerdisch@openheart.net., Hagberg RC; Department of Cardiac Surgery, Hartford Hospital, Hartford, Conn., Perchinsky MJ; Department of Surgery, Royal Jubilee Hospital, Victoria, British Columbia, Canada., Joseph M; Department of Surgery, Virginia Tech Carilion School of Medicine, Roanoke, Va., Oo AY; Department of Cardiovascular Surgery, Bart's Health NHS Trust, London, United Kingdom., Loubani M; Department of Cardiothoracic Surgery, Hull University Teaching Hospitals NHS Trust, Hull, United Kingdom., Tsang GM; Department of Cardiac Surgery, Southampton General Hospital, Southampton, United Kingdom., Zacharias J; Department of Cardiothoracic Surgery, Blackpool Teaching Hospitals Foundation Trust, Blackpool, United Kingdom., Sathyamoorthy M; Department of Internal Medicine, Burnett School of Medicine at TCU, Fort Worth, Tex.
Jazyk:	angličtina
Zdroj:	The Journal of thoracic and cardiovascular surgery [J Thorac Cardiovasc Surg] 2024 Dec; Vol. 168 (6), pp. 1645-1655.e6. Date of Electronic Publication: 2024 Apr 28.
DOI:	10.1016/j.jtcvs.2024.04.017
Abstrakt:	Objectives: To evaluate whether warfarin targeted at an international normalized ratio of 1.8 (range, 1.5-2.0) after On-X mechanical aortic valve implant is safe for all patients. Methods: This prospective, observational clinical registry assessed adverse event rates in adult patients receiving low-dose warfarin (target international normalized ratio, 1.8; range, 1.5-2.0) plus daily aspirin (75-100 mg) during a 5-year period after On-X aortic valve implant. The primary end point is the combined rate of major bleeding, valve thrombosis, and thromboembolism overall and in 4 subgroups. The comparator is the Prospective Randomized On-X Anticoagulation Trial control group patients on standard-dose warfarin (international normalized ratio, 2.0-3.0) plus aspirin 81 milligrams daily. Results: A total of 510 patients were recruited at 23 centers in the United States, United Kingdom, and Canada between November 2015 and January 2022. This interim analysis includes 229 patients scheduled to complete 5-year follow-up by August 16, 2023. The linearized occurrence rate (in percent per patient-year) of the primary composite end point of major bleeding, valve thrombosis, and thromboembolism is 1.83% compared with 5.39% (95% confidence interval, 4.12%-6.93%) in the comparator group. Results are consistent in clinic-monitored and home-monitored patients and in those at high risk for thromboembolism. Major bleeding and total bleeding were reduced by 87% and 71%, respectively, versus the comparator group, without an increase in thromboembolic events. Conclusions: Interim results support the continued safety of the On-X aortic mechanical valve with a target international normalized ratio of 1.8 plus low-dose aspirin through 5 years after implant, with or without home monitoring. Competing Interests: Conflict of Interest Statement M.W.G., M.J.P., M.J., A.Y.O., M.L., G.M.T., J.Z., and M.S. hold a consulting agreement with Artivion. R.C.H. reported no conflicts of interest. The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling or reviewing manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest. (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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