A randomized trial of prasugrel versus clopidogrel in patients with high platelet reactivity on clopidogrel after elective percutaneous coronary intervention with implantation of drug-eluting stents
JACC - Journal of the American College of Cardiology, 06/05/2012
Trenk D et al. – Switching from clopidogrel to prasugrel in patients with high on–treatment platelet reactivity (HTPR) afforded effective platelet inhibition. However, given the low rate of adverse ischemic events after percutaneous coronary intervention (PCI) with contemporary drug–eluting stent (DES) in stable coronary artery disease (CAD), the clinical utility of this strategy could not be demonstrated.Methods
- Stable coronary artery disease (CAD) patients with HTPR (>208 P2Y12 reaction units [PRU] by the VerifyNow test) after elective PCI with at least 1 drug–eluting stent (DES) were randomly assigned to either prasugrel 10 mg daily or clopidogrel 75 mg daily.
- Platelet reactivity of the patients on the study drug was reassessed at 3 and 6 months.
- The study was stopped prematurely for futility because of a lower than expected incidence of the primary endpoint.
- In 212 patients assigned to prasugrel, PRU decreased from 245 (225 to 273) (median [interquartile range]) at baseline to 80 (42 to 124) at 3 months, whereas in 211 patients assigned to clopidogrel, PRU decreased from 249 (225 to 277) to 241 (194 to 275) (p < 0.001 vs. prasugrel).
- The primary efficacy endpoint of cardiac death or myocardial infarction at 6 months occurred in no patient on prasugrel versus 1 on clopidogrel.
- The primary safety endpoint of non–coronary artery bypass graft Thrombolysis In Myocardial Infarction major bleeding at 6 months occurred in 3 patients (1.4%) on prasugrel versus 1 (0.5%) on clopidogrel.