SPORTIF V

Stroke Prevention using an ORal Thrombin Inhibitor in atrial Fibrillation V (2005)

Condition

Prevention of VTE in non-valvular AF

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Objective

To compare the efficacy of ximelagatran with warfarin for the prevention of stroke and systemic embolism

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Trial design

Randomized, double-blind phase III study, non-inferiority design
Active treatment: ximelagatran 36 mg twice daily (n=1960)
Control treatment: warfarin (INR 2.0–3.0) (n=1962)

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Endpoints

Primary endpoint: all strokes (ischemic or hemorrhagic) and systemic embolic events
Secondary endpoints: composite of stroke, systemic embolic events, death, myocardial infarction; composite of ischemic stroke, TIA, systemic embolic events; major bleeding; major and minor bleeding; adverse events

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Trial participants

3922 patients with non-valvular AF and additional stroke risk factors

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Results

Efficacy outcome: In the intent-to-treat population, primary events occurred in 51 of 1960 patients (1.6%) in the ximelagatran group and in 37 of 1962 patients (1.2%) in the warfarin group (absolute difference 0.45%; p<0.001 for the predefined non-inferiority hypothesis).The primary event or death occurred in 153 patients given ximelagatran (4.8%) and 151 patients given warfarin (4.7%)
Safety outcome: In the on-treatment population, major and minor bleeding occurred in 737 patients (37%) with ximelagatran compared to 903 patients (47%) with warfarin (relative risk reduction 21%). Almost all events were minor bleedings. There was no significant difference in major bleedings. Elevations of serum ALT levels above 3x ULN were observed in 6% of the patients treated with ximelagatran compared to 0.8% of the patients receiving warfarin

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Summary

Efficacy: In high-risk patients with atrial fibrillation, fixed-dose oral ximelagatran was non-inferior to warfarin

  • in the prevention of stroke and SEE
  • in the prevention of stroke, SEE and death

Safety: Compared to warfarin ximelagatran was associated with a

  • lower total bleeding rate
  • lower minor bleeding rate
  • comparable rate of major bleeding
  • higher incidence of liver enzyme elevations requiring further consideration

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Reference

Albers GW, Diener HC, Frison L, Grind M, Nevinson M, Partridge S, Halperin JL, Horrow J, Olsson SB, Petersen P, Vahanian A for the SPORTIV V investigators. Ximelagatran vs warfarin for stroke prevention in patients with nonvalvular atrial fibrillation: a randomized trial. J Am Med Ass 2005;293:690-698

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Corresponding author

Jonathan L. Halperin, MD, The Zena and Michael A. Wiener Cardiovascular Institute and The Marie-Josée and Henry R. Kravis Center for Cardiovascular Health, Mount Sinai Medical Center, One Gustave L. Levy Place, New York, NY 10024
e-mail: Jonathan.Halperin@msnyuhealth.org

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