Background -Elderly patients are at elevated risk of both ischemic and bleeding complications after an acute coronary syndrome (ACS), and display higher on-clopidogrel platelet reactivity as compared to younger patients. Prasugrel 5 mg provides more predictable platelet inhibition, as compared to clopidogrel, in the elderly, suggesting the possibility of reducing ischemic events without increasing bleeding. Methods -In a multicenter, randomized, open-label, blinded-endpoint trial, we compared a once daily maintenance dose of prasugrel 5 mg with the standard clopidogrel 75 mg in patients >74 years with ACS undergoing percutaneous coronary intervention (PCI). The primary endpoint was the composite of mortality, myocardial infarction, disabling stroke and re-hospitalization for cardiovascular causes or bleeding within one year. The study was designed to demonstrate superiority of prasugrel 5 mg over clopidogrel 75 mg. Results -Enrolment was interrupted, according to pre-specified criteria, after a planned interim analysis, when 1443 patients (40% women, mean age 80 years) had been enrolled, with a median follow-up of 12 months, due to futility for efficacy. The primary endpoint occurred in 121 patients (17%) with prasugrel and 121 (16.6%) with clopidogrel (HR 1.007, 95% CI, 0.78-1.30;P=0.955). Definite/probable stent thrombosis rates were 0.7% with prasugrel vs 1.9% with clopidogrel (OR 0.36, C.I. 0.13-1.00, p=0.06). Bleeding Academic Research Consortium types ≥2 were 4.1% with prasugrel vs 2.7% with clopidogrel (OR 1.52, C.I. 0.85-3.16, P= 0.18). Conclusions -The present study in elderly ACS patients showed no difference in the primary endpoint between reduced-dose prasugrel and standard-dose clopidogrel. However, the study should be interpreted in the light of premature termination of the trial. Clinical Trial Registration -URL: https://clinicaltrials.gov/ Unique Identifier: NCT01777503.

Comparison of Reduced-Dose Prasugrel and Standard-Dose Clopidogrel in Elderly Patients with Acute Coronary Syndromes Undergoing Early Percutaneous Revascularization

De Luca, Giuseppe;
2018-01-01

Abstract

Background -Elderly patients are at elevated risk of both ischemic and bleeding complications after an acute coronary syndrome (ACS), and display higher on-clopidogrel platelet reactivity as compared to younger patients. Prasugrel 5 mg provides more predictable platelet inhibition, as compared to clopidogrel, in the elderly, suggesting the possibility of reducing ischemic events without increasing bleeding. Methods -In a multicenter, randomized, open-label, blinded-endpoint trial, we compared a once daily maintenance dose of prasugrel 5 mg with the standard clopidogrel 75 mg in patients >74 years with ACS undergoing percutaneous coronary intervention (PCI). The primary endpoint was the composite of mortality, myocardial infarction, disabling stroke and re-hospitalization for cardiovascular causes or bleeding within one year. The study was designed to demonstrate superiority of prasugrel 5 mg over clopidogrel 75 mg. Results -Enrolment was interrupted, according to pre-specified criteria, after a planned interim analysis, when 1443 patients (40% women, mean age 80 years) had been enrolled, with a median follow-up of 12 months, due to futility for efficacy. The primary endpoint occurred in 121 patients (17%) with prasugrel and 121 (16.6%) with clopidogrel (HR 1.007, 95% CI, 0.78-1.30;P=0.955). Definite/probable stent thrombosis rates were 0.7% with prasugrel vs 1.9% with clopidogrel (OR 0.36, C.I. 0.13-1.00, p=0.06). Bleeding Academic Research Consortium types ≥2 were 4.1% with prasugrel vs 2.7% with clopidogrel (OR 1.52, C.I. 0.85-3.16, P= 0.18). Conclusions -The present study in elderly ACS patients showed no difference in the primary endpoint between reduced-dose prasugrel and standard-dose clopidogrel. However, the study should be interpreted in the light of premature termination of the trial. Clinical Trial Registration -URL: https://clinicaltrials.gov/ Unique Identifier: NCT01777503.
2018
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11570/3256224
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