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Ximelagatran Appears As Effective As Warfarin for Prevention of Stroke and Systemic Embolism in Select Atrial Fibrillation Patients
Lancet
11/21/2003
By Joene Hendry
Ximelagatran is as effective against thromboembolism as is warfarin in high-risk patients with non-valvular atrial fibrillation, according to the findings of a randomised controlled trial conducted in 23 countries in Europe, Asia, and Australasia.
"Furthermore, although anticoagulation intensity was not monitored or regulated in patients assigned to ximelagatran, these patients had less bleeding than those assigned to warfarin and carefully adjusted according to contemporary treatment standards," writes Professor S. Bertil Olsson, University Hospital, Lund, Sweden, and colleagues on the Executive Steering Committee of the Stroke Prevention Using an Oral Thrombin Inhibitor in Atrial Fibrillation (SPORTIF III) Investigators.
The researchers analysed the occurrence of stroke or systemic embolism during 4941 patient-years of exposure in patients with atrial fibrillation and 1 or more stroke risk factors. Patients were divided into 2 groups: 1704 were assigned to receive 36 mg ximelagatran twice daily (68% male, mean age 70.3 years) and 1703 patients were given warfarin adjusted to international normalised ratio (INR) between 2.0 and 3.0 (70% male, mean age 70.1 years).
Per patient year, primary events occurred in 1.6% of the ximelagatran group and in 2.3% of the warfarin group, including ischaemic stroke in 1.3% and 1.9%, haemorrhagic stroke in 0.2% and 0.4%, and systemic embolism in 0.2% and 0.1%, respectively. Per patient year mortality rates were 3.2% in both groups.
The per patient year composite of major and minor haemorrhages shows 25.8% in the ximelagatran group compared with 29.8% in the warfarin group. Among those patients concurrently taking 100 mg/day or more of aspirin, the overall composite per patient year bleeding rates were 35.5% in the ximelagatran and 52.1% in the warfarin groups.
Overall adverse events occurred in 87% and in 85% of the ximelagatran and warfarin groups, respectively with raised serum alanine aminotransferase more commonly occurring in the ximelagatran treated patients.
The investigators calculated the combined rates of deaths, primary events, and major bleeding during treatment and report that 104 such events occurred with ximelagatran (4.6% per year) and 143 events occurred with warfarin (6.1% per year).
"These findings set ximelagatran apart as a new oral anticoagulant drug," the authors conclude, "representing a distinct innovation in long-term anticoagulant treatment."
Lancet 2003;362:1691-98.
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