Objective: To study the efficacy of the low standard oral anticoagulation therapy following St Jude Medical (SJM) valve implantation for Chinese patients.
Methods: Totally 805 patients with a mean age of 42.70 +/- 11.09 years, enrolled into this study. Among them, 230 underwent aortic valve replacements (AVR), 381 mitral valve replacements (MVR), 189 double valve replacements (DVR) and 5 tricuspid valve replacements (TVR). All patients received postoperative oral anticoagulation therapy based on a low standard of international normalized ratio (INR, 2.0 - 2.5). Of the 805 patients, 710 were followed up for 0.25 - 13 years (a median, 4.15 years).
Results: Postoperatively, 17 adverse events occurred. Operative mortality was 2.11%. The most frequent cause of operative mortality was a low cardiac output. During follow-up, there were 47 anticoagulant-induced hemorrhages [1.59%/patient-year (pt-yr)], 10 cases of thromboembolism (0.34%/pt-yr), and 3 mechanical valve thromboses (0.19%/pt-yr). There were 44 late deaths and the linearized late mortality rates were 0.51%pt-yr. Estimates of actuarial survival for all patients at 5 and 10 years was 97.45% (0.70%) and 77.96% (17.44%), respectively.
Conclusions: A low target INR range of 2.0 - 2.5 is preferable for Chinese patients so as to reduce the severe bleeding complications in those with conventionally higher levels of INR. The long-term results were satisfactory in terms of the numbers of those who suffered thrombosis, embolism and bleeding.