Prasugrel versus clopidogrel in patients with acute coronary syndromes
- PMID: 17982182
- DOI: 10.1056/NEJMoa0706482
Prasugrel versus clopidogrel in patients with acute coronary syndromes
Abstract
Background: 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.
Methods: To compare prasugrel, a new thienopyridine, with clopidogrel, we randomly assigned 13,608 patients with moderate-to-high-risk acute coronary syndromes with scheduled percutaneous coronary intervention to receive prasugrel (a 60-mg loading dose and a 10-mg daily maintenance dose) or clopidogrel (a 300-mg loading dose and a 75-mg daily maintenance dose), for 6 to 15 months. The primary efficacy end point was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The key safety end point was major bleeding.
Results: The primary efficacy end point occurred in 12.1% of patients receiving clopidogrel and 9.9% of patients receiving prasugrel (hazard ratio for prasugrel vs. clopidogrel, 0.81; 95% confidence interval [CI], 0.73 to 0.90; P<0.001). We also found significant reductions in the prasugrel group in the rates of myocardial infarction (9.7% for clopidogrel vs. 7.4% for prasugrel; P<0.001), urgent target-vessel revascularization (3.7% vs. 2.5%; P<0.001), and stent thrombosis (2.4% vs. 1.1%; P<0.001). Major bleeding was observed in 2.4% of patients receiving prasugrel and in 1.8% of patients receiving clopidogrel (hazard ratio, 1.32; 95% CI, 1.03 to 1.68; P=0.03). Also greater in the prasugrel group was the rate of life-threatening bleeding (1.4% vs. 0.9%; P=0.01), including nonfatal bleeding (1.1% vs. 0.9%; hazard ratio, 1.25; P=0.23) and fatal bleeding (0.4% vs. 0.1%; P=0.002).
Conclusions: In patients with acute coronary syndromes with scheduled percutaneous coronary intervention, prasugrel therapy was associated with significantly reduced rates of ischemic events, including stent thrombosis, but with an increased risk of major bleeding, including fatal bleeding. Overall mortality did not differ significantly between treatment groups. (ClinicalTrials.gov number, NCT00097591 [ClinicalTrials.gov].)
Copyright 2007 Massachusetts Medical Society.
Comment in
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Intensifying platelet inhibition--navigating between Scylla and Charybdis.N Engl J Med. 2007 Nov 15;357(20):2078-81. doi: 10.1056/NEJMe0706859. Epub 2007 Nov 4. N Engl J Med. 2007. PMID: 17982183 No abstract available.
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Prasugrel versus clopidogrel.N Engl J Med. 2008 Mar 20;358(12):1298; author reply 1299-301. doi: 10.1056/NEJMc073398. N Engl J Med. 2008. PMID: 18354110 No abstract available.
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Prasugrel versus clopidogrel.N Engl J Med. 2008 Mar 20;358(12):1298-9; author reply 1299-301. N Engl J Med. 2008. PMID: 18357638 No abstract available.
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Prasugrel versus clopidogrel.N Engl J Med. 2008 Mar 20;358(12):1299; author reply 1299-301. N Engl J Med. 2008. PMID: 18357639 No abstract available.
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Should Prasugrel or Clopidogrel Be Used in Patients with ACS?Curr Cardiol Rep. 2008 Jul;10(4):301-2. doi: 10.1007/s11886-008-0048-7. Curr Cardiol Rep. 2008. PMID: 18611364 No abstract available.
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[Commentary to the article: Wiviott S D, Braunwald E, McCabe C H et al. Prasugrel versus clopidogrel in patients with acute coronary syndrome. N Engl J Med 2007; 357: 2001-15].Kardiol Pol. 2008 Feb;66(2):222-5; discussion 225-6. Kardiol Pol. 2008. PMID: 18634190 Polish. No abstract available.
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Commentary. Prasugrel versus clopidogrel in patients with acute coronary symptoms.Perspect Vasc Surg Endovasc Ther. 2008 Jun;20(2):223-4. doi: 10.1177/1531003508317596. Perspect Vasc Surg Endovasc Ther. 2008. PMID: 18644816 No abstract available.
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Reducing cardiac ischemic events in patients with ACS: prasugrel versus clopidogrel. Commentary.Postgrad Med. 2010 Jan;122(1):198-200. doi: 10.3810/pgm.2010.01.2115. Postgrad Med. 2010. PMID: 20107305 Clinical Trial.
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