Oral anticoagulation in patients after cerebral ischemia of arterial origin and risk of intracranial hemorrhage

Background and Purpose-In the recently published Warfarin Aspirin Recurrent Stroke Study (WARSS), a low-intensity anticoagulation regimen was used because of safety concerns. Such concerns are corroborated by the results of the Stroke Prevention in Reversible Ischemia Trial (SPIRIT), which was stopped early because of a high incidence of intracranial hemorrhage with a target international normalized ratio (INR) of 3.0 to 4.5. In the ongoing European/Australasian Stroke Prevention in Reversible Ischaemia Trial (ESPRIT), an intermediate anticoagulation regimen (INR 2.0 to 3.0) is used. Methods-We performed an interim analysis of the incidence of intracranial hemorrhage in ESPRIT. Results-Thus far the overall rate of intracranial hemorrhage is 0.31% (95% CI, 0.18% to 0.52%) per year and 1.21% if all of these were in the anticoagulation group. Conclusions-We conclude that anticoagulation with achieved INR of 2.0 to 3.0 is reasonably safe in patients with cerebral ischemia of arterial origin.