Warfarin vs. Asprin in Reduced Ejection Fraction
Warfarin vs. Asprin in Reduced Ejection Fraction
Warfarin vs. Asprin in Reduced Ejection Fraction
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Statistical Design<br />
• Primary null hypothesis<br />
No overall difference between warfar<strong>in</strong> (target<br />
INR 2.75) and aspir<strong>in</strong> (325 mg/day) <strong>in</strong> time to first<br />
to occur of ischemic stroke, <strong>in</strong>tracerebral<br />
hemorrhage, or death.<br />
• = 0.05 two-sided for superiority<br />
• Power 80% for 17.8% HR reduction.<br />
(achieved 67% after recruitment curtailed)<br />
• Given long follow-up (6 yrs maximum),<br />
prespecified analysis provides for a time-vary<strong>in</strong>g<br />
treatment effect (treatment by time <strong>in</strong>teraction) if<br />
hazards are nonproportional
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