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ABSTRACT

Background The optimal intensity of oral anticoagulant therapy for patients with mechanical heart valves (i.e., the level at which thromboembolic complications are effectively prevented without excessive bleeding) is not known. We attempted to determine the optimal intensity by calculating the incidence of both complications at different levels of anticoagulation.

Methods Data were collected on all patients with mechanical heart valves who have been seen at four regional Dutch anticoagulation clinics since 1985. The primary outcome events were episodes of thromboembolism or major bleeding. The intensity-specific incidence of each type of event was calculated as the number of events that occurred at a certain intensity of anticoagulation (expressed in terms of the international normalized ratio [INR]) divided by the number of patient-years during which the INR was at this level in the total patient population.

Results A total of 1608 patients were followed during 6475 patient-years. Cerebral embolism occurred in 43 patients (0.68 per 100 patient-years) and peripheral embolism in 2 (0.03 per 100 patient-years). Intracranial and spinal bleeding occurred in 36 patients (0.57 per 100 patient-years) and major extracranial bleeding in 128 (2.1 per 100 patient-years). The optimal intensity of anticoagulation, at which the incidence of both complications was lowest, was achieved when the INR was between 2.5 and 4.9.

Conclusions The intensity of anticoagulant therapy for patients with prosthetic heart valves is optimal when the INR is between 2.5 and 4.9. To achieve this level of anticoagulation, a target INR of 3.0 to 4.0 is recommended.

Source Information

From the Hemostasis and Thrombosis Research Center, Department of Hematology (S.C.C., F.R.R., F.J.M.M., E.B.), the Department of Clinical Epidemiology (F.R.R., J.P.V.), and the Department of Neurology (A.R.W.), University Hospital Leiden; and the Leiden Anticoagulation Clinic (F.J.M.M.) -- both in Leiden, the Netherlands. The institutions, investigators, and general practitioners participating in the Leiden Artificial Valve and Anticoagulation Study are listed in the Appendix.

Address reprint requests to Dr. Cannegieter at the Hemostasis and Thrombosis Research Center, Department of Hematology, Bldg. 1, C2-R, University Hospital Leiden, P.O. Box 9600, 2300 RC Leiden, the Netherlands.

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Optimal Oral Anticoagulation for Patients with Mechanical Heart Valves
von Schacky C., Cannegieter S.C., Rosendaal F.R.
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N Engl J Med 1995; 333:1504-1505, Nov 30, 1995. Correspondence

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