On-X aortic valve replacement patients treated with low-dose warfarin and low-dose aspirin.

Autor: Oo AY; Department of Cardiovascular Surgery, Bart's Health NHS Trust, London, UK., Loubani M; Department of Cardiothoracic Surgery, Hull University Teaching Hospitals NHS Trust, Hull, UK., Gerdisch MW; Department of Cardiothoracic Surgery, Franciscan Health, Indianapolis, IN, USA., Zacharias J; Department of Cardiothoracic Surgery, Blackpool Teaching Hospitals Foundation Trust, Blackpool, UK., Tsang GM; Department of Cardiac Surgery, Southampton General Hospital, Southampton, UK., Perchinsky MJ; Department of Surgery, Royal Jubilee Hospital, Victoria, BC, Canada., Hagberg RC; Department of Cardiac Surgery, Hartford Hospital, Hartford, CT, USA., Joseph M; Department of Surgery, Virginia Tech Carilion School of Medicine, Roanoke, VA, USA., Sathyamoorthy M; Department of Internal Medicine, Burnett School of Medicine at TCU, Fort Worth, TX, USA.
Jazyk: angličtina
Zdroj: European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery [Eur J Cardiothorac Surg] 2024 May 03; Vol. 65 (5).
DOI: 10.1093/ejcts/ezae117
Abstrakt: Objectives: To assess if warfarin targeted to international normalized ratio (INR) 1.8 (range 1.5-2.0) is safe for all patients with an On-X aortic mechanical valve.
Methods: This prospective, observational registry follows patients receiving warfarin targeted at an INR of 1.8 (range 1.5-2.0) plus daily aspirin (75-100 mg) after On-X aortic valve replacement. The primary end point is a composite of thromboembolism, valve thrombosis and major bleeding. Secondary end points include the individual rates of thromboembolism, valve thrombosis and major bleeding, as well as the composite in subgroups of home or clinic-monitored INR and risk categorization for thromboembolism. The control was the patient group randomized to standard-dose warfarin (INR 2.0-3.0) plus daily aspirin 81 mg from the PROACT trial.
Results: A total of 510 patients were enroled at 23 centres in the UK, USA and Canada. Currently, the median follow-up duration is 3.4 years, and median achieved INR is 1.9. The primary composite end point rate in the low INR patients is 2.31% vs 5.39% (95% confidence interval 4.12-6.93%) per patient-year in the PROACT control group, constituting a 57% reduction. Results are consistent in subgroups of home or clinic-monitored, and high-risk patients, with reductions of 56%, 57% and 57%, respectively. Major and total bleeding are decreased by 85% and 73%, respectively, with similar rates of thromboembolic events. No valve thrombosis occurred.
Conclusions: Interim results suggest that warfarin targeted at an INR of 1.8 (range 1.5-2.0) plus aspirin is safe and effective in patients with an On-X aortic mechanical valve with or without home INR monitoring.
(© The Author(s) 2024. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)
Databáze: MEDLINE