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J Thorac Cardiovasc Surg 1997;113:910-916
© 1997 Mosby, Inc.
SURGERY FOR ACQUIRED HEART DISEASE |
Presented in abstracted form in the XIVth Congress of the International Society of Thrombosis and Haemostasis, New York, N.Y., July 1993.
Received for publication August 6, 1996; revisions requested Oct. 21, 1996; revisions received Nov. 19, 1996; accepted for publication Nov. 21, 1996. Address for reprints: Susana S. Meschengieser, Departamento de Hemostasia y Trombosis, Instituto de Investigaciones Hematologicas "Mariano R. Castex," Academia Nacional de Medicina, Pacheco de Melo 3081, Buenos Aires, Argentina 1425.
Abstract
Background: Mechanical heart valve replacement requires lifelong anticoagulant treatment. Aspirin has proved useful in further reducing thromboembolic events when added to oral anticoagulants. However, increased (gastrointestinal) bleeding was observed at the doses previously tested for this combination in heart valve prostheses. Methods: We performed a prospective randomized trial to compare the combination of low-intensity oral anticoagulants (international normalized ratio 2.5 to 3.5) plus aspirin (100 mg/day)(arm A) versus high-intensity oral anticoagulants alone (arm B) (international normalized ratio 3.5 to 4.5). Arm A included 258 patients and arm B 245 patients. The two groups were comparable for all baseline characteristics. Results: The outcomes of the study were embolism, valve thrombosis, and major hemorrhage. The median follow-up was 23 months. The two treatments offered similar antithrombotic protection. The incidence of embolic episodes was 1.32 per 100 patient-years (95% confidence interval 0.53 to 2.7) for arm A and 1.48 per 100 patient-years (95% confidence interval 0.59 to 3.03) for arm B. Major hemorrhage occurred in 1.13 per 100 patient-years (95% confidence interval 0.41 to 2.45) for arm A and 2.33 per 100 patient-years (95% confidence interval 1.17 to 4.14) for arm B. Gastrointestinal bleeding was not increased by this combined reduced dose of aspirin and coumarin.
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