Stroke Prevention Using the Oral Direct Thrombin Inhibitor Ximelagatran in Patients With Nonvalvular

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Stroke Prevention Using the Oral Direct Thrombin
Inhibitor Ximelagatran in Patients With
Nonvalvular Atrial Fibrillation
SPORTIF V Trial
Presented at American Heart Association Scientific
Sessions 2003 Presented By Jonathan L Halperin,
M.D.
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SPORTIF V Trial
3,922 patients with nonvalvular AF and risk
factors for stroke (previous stroke,
hypertension, or CHF)
Randomized Double-blind to

• Ximelagatran (36 mg bid)
• A novel, oral direct thrombin inhibitor
  ximelagatran
• (n 1,960)

• Warfarin
• Target INR 2.0-3.0
• (n 1,962)

• Endpoints (mean follow-up 20 months)
• Primary All strokes (ischemic or hemorrhagic)
  and systemic embolic events, based on an
  intention-to-treat analysis for non-inferiority
• Secondary Composite of death, stroke, systemic
  embolism, and MI and safety variables,
  specifically bleeding and liver enzyme elevations

AHA 2003 Late Breaking Trials
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SPORTIF V Trial Strokes (ischemic or
hemorrhagic) and Systemic Embolic Events
Intent-to-Treat Absolute 0.45 annual ? in
ximelagatran arm (95 CI -0.13-1.03, p0.13) Met
non-inferiority hypothesis

• In As-Treated Analysis
• Absolute 0.55 annual ?
• in ximelagatran arm
• 95 CI -0.06-1.16
• p0.089

Event Rate ( per year)
Warfarin
Ximelagatran
AHA 2003 Late Breaking Trials
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SPORTIF V Trial Bleeding Events
pNS
pNS
Event Rate ( per year)
ICH
Major Bleed
AHA 2003 Late Breaking Trials
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SPORTIF V Trial Liver Enzyme Elevation
ALT gt3x ULN plt0.001
Warfarin
Ximelagatran
AHA 2003 Late Breaking Trials
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SPORTIF V Trial Combined Major Adverse
EventsOn-Treatment Analysis
Primary Events Major Bleeding Death p0.527
Event Rate ( per year)
Warfarin
Ximelagatran
AHA 2003 Late Breaking Trials