[Optimum anticoagulation control after bileaflet mechanical valve replacement: a prospective multi-institutional study].

This study was undertaken to assess optimum anticoagulation control after bileaflet mechanical valve replacement by using the international normalized ratio of prothrombin time (PT-INR). From January to December 1995, 261 patients (pts) underwent mechanical valve replacement in the aortic (n = 95), mitral (n = 126), aortomitral (n = 39) or isolated tricuspid (n = 1) valve position in 8 medical centers in Tokyo, Japan. The St. Jude Medical valves were implanted in 184 pts and the Carbomedics valves in 77. There were 17 valve-related events as follows: 11 thromboembolic events (3.62%/pt-yr) including 10 transient ischemic attacks. 5 non-fatal bleeding events (1.65%/pt-yr), 2 reoperations (0.66%/pt-yr). At 18 postoperative months, free rates from all deaths (actuarial survival) thromboembolism, reoperation and all valve-related events were 95.3%, 95.7%, 98.7% and 88.9%, respectively. Under anticoagulant therapy, thrombin-antithrombin III complex and D-dimmer remained in high levels at 1 month after operation, and both values decreased to the control level at 6 months. In patients with thromboembolic events, PT-INR tended to be less than 2.0. The patients with bleeding events showed some increase of PT-INP or received anti-platelet agents. The 5 to 95 percentile of PT-INR at 6 months was 1.2 to 3.0 in the patients without valve-related events. These results suggested that optimum range of PT-INR might be between 1.2 and 3.0 after bileaflet mechanical valve replacement in patients without high risk of thromboembolism and between 2.0 and 3.0 in patients with the high risk.