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

OBJECTIVES To assess if warfarin targeted to 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 enrolled at 23 centers in the UK, United States, 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.