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Presentation Outline ICHP Annual Meeting September 13-15

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VTE<br />

recurrence<br />

during<br />

study<br />

period<br />

VTE<br />

recurrence<br />

during<br />

study<br />

treatment<br />

WARFASA<br />

Primary Outcome: Recurrence of VTE within 2 years<br />

Aspirin (n=205) Placebo (n=197)<br />

28 43<br />

(6.6% per year) (11.2% per year)<br />

23<br />

(5.9% per year)<br />

N Engl J Med. 2012;366(21):1959-1967.<br />

39<br />

(11.0% per year)<br />

WARFASA<br />

HR with<br />

95% CI<br />

P‐value NNT<br />

HR, 0.58;<br />

95% CI CI,<br />

0.36 to 0.93<br />

PP=0.02 0 02 22<br />

HR, 0.55;<br />

95% CI,<br />

0.33 to 0.92<br />

P=0.02 20<br />

• Results –Post hoc<br />

– Patients with prior PE who had recurrence:<br />

• Aspirin: 6.7% per year<br />

• Placebo: <strong>13</strong>.5% per year<br />

• HR, 0.38; 95% CI, 0.17 to 0.88; P=0.02<br />

– Patients with prior DVT who had recurrence:<br />

• Aspirin: 6.5% per year<br />

• Placebo: 10.2% per year<br />

• HR, 0.65; 95% CI, 0.65 to 1.20; P=0.17<br />

N Engl J Med. 2012;366(21):1959-1967.<br />

WARFASA<br />

• Results – Secondary<br />

– Death (any cause)<br />

• Aspirin: 6 patients (1.4% per year)<br />

• Placebo: 5 patients (1.3% per year)<br />

– Arterial events<br />

• Aspirin: 8 patients (including 2 MIs, 2 strokes)<br />

• Placebo: 5 patients (including 2 MIs, 1 stroke)<br />

– Major bleeding<br />

• 1 event in each group<br />

N Engl J Med. 2012;366(21):1959-1967.<br />

8/30/2012<br />

5

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