Why the study?
What are the incidence rates of bleeding and thromboembolic events in patients with noncardiac cerebral ischemia treated with oral anticoagulants?
What are the incidence rates of bleeding and thromboembolic events in patients with noncardiac cerebral ischemia treated with oral anticoagulants?
Oral anticoagulation for noncardiac cerebral ischemia carries a high risk of hemorrhage, particularly in the first 6 months and in patients over 65, with an optimal INR target of 2.5 to 3.5.
High event rates on anticoagulation in noncardiac cerebral ischemia warrant individualized risk assessment; leaves open optimal intensity and duration in trials.
BACKGROUND: The use of oral anticoagulant therapy for the prevention of arterial thromboembolism in patients who have had ischemic stroke is controversial. Coumarins may increase the bleeding risk in patients with cerebral ischemia of arterial origin. OBJECTIVES: 1) To calculate incidence rates of bleeding and thromboembolic events in patients with noncardiac cerebral ischemia who were treated routinely in an anticoagulation clinic. 2) To assess which factors contribute to the occurrence of events. 3) To determine the optimal intensity of oral anticoagulant therapy in these patients. METHODS: The authors studied all patients treated for noncardiac cerebral ischemia at the Leiden anticoagulation clinic between 1993 and 1998. Outcome events were major hemorrhage, major arterial thromboembolism, and death. RESULTS: The authors observed 356 patients for 644 patient-years. The incidence of major hemorrhage was 3.9 per 100 patient-years (95% CI, 2.5 to 5.7) and that of thromboembolism was 3.0 per 100 patient-years (95% CI, 1.8 to 4.6). The incidence of hemorrhage varied with the duration of treatment (relative risk [RR] of the first versus the second half-year, 3.8; 95% CI, 1.9 to 7.6), age (RR for age >65 years, 3.7; 95% CI, 1.1 to 12.3), and the intensity of oral anticoagulation (RR, 1.8 for each 0.5 international normalized ratio [INR] unit increase; 95% CI, 1.5 to 2.3). The optimal intensity of oral anticoagulant therapy was 2.5 to 3.5 INR; the best target value was 3.0 INR. CONCLUSION: The risk of hemorrhage with anticoagulant therapy is high in patients with ischemic stroke of arterial origin but is mainly confined to early use and elderly patients.
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Torn et al. (2001) studied this question.
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