Q&A

Ximelagatran effective in preventing stroke in a nonvalvular atrial fibrillation

J Fam Pract. 2004 April;53(4):261-268
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  • CLINICAL QUESTION: Is ximelagatran as effective as warfarin in preventing stroke for patients with nonvalvular atrial fibrillation?
  • STUDY DESIGN:Randomized controlled trial (nonblinded)
  • SETTING: Other
  • SYNOPSIS: Patients with atrial fibrillation were recruited from hospitals, doctor’s offices, and health-care clinics to participate in this manufacturer-sponsored open-label study comparing fixed doses of ximelagatran (n=1704) with warfarin dosed to maintain an international normalized ratio (INR) between 2.0 and 3.0 (n=1703). Patients also needed to have at least 1 additional stroke risk factor to be included: hypertension, age older than 75 years, previous thromboembolic phenomena, left ventricular ejection fraction less than 40%, symptomatic congestive heart failure, or age older than 65 years with coronary artery disease or diabetes mellitus.
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BOTTOM LINE

In this manufacturer-sponsored, open-label study, patients with atrial fibrillation and at increased risk for stroke treated with either ximelagatran or warfarin have comparable outcomes. If these results are confirmed independently, ximelagatran may become the preferred treatment, since it doesn’t require monitoring and may cause fewer bleeding complications. (LOE=2b).

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