Prasugrel versus Clopidogrel in Patients with Acute Coronary Syndromes

<p>
Dual-antiplatelet therapy with aspirin and a thienopyridine is a cornerstone of treatment ,
to prevent thrombotic complications of acute coronary syndromes and percutaneous
coronary intervention.
</p>
<p></p>
<p>To compare prasugrel, a new thienopyridine, with clopidogrel, we randomly assigned</p>
<p>13,608 patients with moderate-to-high-risk acute coronary syndromes with scheduled</p>
<p>percutaneous coronary intervention to receive prasugrel (a 60-mg loading dose</p>
<p>and a 10-mg daily maintenance dose) or clopidogrel (a 300-mg loading dose and a</p>
<p>75-mg daily maintenance dose), for 6 to 15 months. The primary efficacy end point</p>
<p>was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal</p>
<p>stroke. The key safety end point was major bleeding.</p>
<p></p>
<p>The primary efficacy end point occurred in 12.1% of patients receiving clopidogrel</p>
<p>and 9.9% of patients receiving prasugrel (hazard ratio for prasugrel vs. clopidogrel,</p>
<p>0.81; 95% confidence interval [CI], 0.73 to 0.90; P&lt;0.001). We also found significant</p>
<p>reductions in the prasugrel group in the rates of myocardial infarction (9.7% for</p>
<p>clopidogrel vs. 7.4% for prasugrel; P&lt;0.001),urgent target-vessel revascularization</p>
<p>(3.7% vs. 2.5%; P&lt;0.001), and stent thrombosis (2.4% vs. 1.1%; P&lt;0.001). Major bleeding</p>
<p>was observed in 2.4% of patients receiving prasugrel and in 1.8% of patients</p>
<p>receiving clopidogrel (hazard ratio, 1.32; 95% CI, 1.03 to 1.68; P = 0.03). Also greater</p>
<p>in the prasugrel group was the rate of life-threatening bleeding (1.4% vs. 0.9%;</p>
<p>P = 0.01), including nonfatal bleeding (1.1% vs. 0.9%; hazard ratio, 1.25; P = 0.23)</p>
<p>and fatal bleeding (0.4% vs. 0.1%; P = 0.002).</p>
<p></p>
<p>In patients with acute coronary syndromes with scheduled percutaneous coronary</p>
<p>intervention, prasugrel therapy was associated with significantly reduced rates of</p>
<p>ischemic events, including stent thrombosis, but with an increased risk of major</p>
<p>bleeding, including fatal bleeding. Overall mortality did not differ significantly</p>
<p>between treatment groups. (ClinicalTrials.gov number, NCT00097591.)</p>
<p></p>
<p>Source: N ENGL J Med 357;20 November 15, 2007</p>