Author + information
- Received December 12, 2011
- Revision received February 10, 2012
- Accepted February 12, 2012
- Published online June 12, 2012.
- Dietmar Trenk, PhD⁎,⁎ (, )
- Gregg W. Stone, MD†,
- Meinrad Gawaz, MD‡,
- Adnan Kastrati, MD§,
- Dominick J. Angiolillo, MD, PhD∥,
- Ulrike Müller, MD¶,
- Gert Richardt, MD#,
- Joseph A. Jakubowski, PhD⁎⁎ and
- Franz-Josef Neumann, MD⁎
- ↵⁎Reprint requests and correspondence:
Dr. Dietmar Trenk, Universitaets-Herzzentrum Freiburg-Bad Krozingen, Klinik fuer Kardiologie und Angiologie, D-79189 Bad Krozingen, Germany
Objectives This study sought to investigate the efficacy, safety, and antiplatelet effect of prasugrel as compared with clopidogrel in patients with high on-treatment platelet reactivity (HTPR) after elective percutaneous coronary intervention (PCI).
Background The extent to which prasugrel can correct HTPR and improve clinical outcomes in patients undergoing elective PCI is unknown.
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.
Results 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.
Conclusions Switching from clopidogrel to prasugrel in patients with HTPR afforded effective platelet inhibition. However, given the low rate of adverse ischemic events after PCI with contemporary DES in stable CAD, the clinical utility of this strategy could not be demonstrated. (Testing platelet Reactivity In patients underGoing elective stent placement on clopidogrel to Guide alternative thErapy with pRasugrel [TRIGGER-PCI]; NCT00910299)
The study was funded by Lilly Research Laboratories. Dr. Trenk has received consulting fees or paid advisory board fees and lecture fees from Eli Lilly Co., Daiichi Sankyo, and AstraZeneca; and lecture fees from sanofi-aventis. Dr. Stone has received consulting fees from Abbott Vascular, Boston Scientific, Medtronic, Eli Lilly Co., Daiichi Sankyo, AstraZeneca, Merck, and The Medicines Company. Dr. Gawaz has received lecture fees from Eli Lilly Co., Bristol-Myers Squibb, and Bayer-Schering; and consulting fees from Bayer-Schering. Dr. Kastrati has received lecture fees and honoraria from Abbott Vascular, AstraZeneca, Bristol-Myers Squibb, Cordis, Daichii Sankyo, Eli Lilly Co., and Medtronic. Dr. Angiolillo has received honoraria for lectures from Bristol-Myers Squibb, Sanofi-Aventis, Eli Lilly Co., Daiichi Sankyo, Abbott Vascular, and AstraZeneca; consulting fees from Bristol-Myers Squibb, sanofi-aventis, Eli Lilly Co., Daiichi Sankyo, The Medicines Company, Portola, Novartis, Medicure, Accumetrics, Arena Pharmaceuticals, Abbott Vascular, AstraZeneca, Merck, and Evolva; and research grants from Bristol-Myers Squibb, Sanofi-Aventis, GlaxoSmithKline, Otsuka, Eli Lilly Co., Daiichi Sankyo, The Medicines Company, Portola, Accumetrics, Schering-Plough, AstraZeneca, and Eisai. Dr. Richardt has received consulting fees from Boston Scientific, Cordis Johnson & Johnson, Abbott Vascular, Medtronic, Eli Lilly Co., and Daiichi Sankyo; and a research grant from Boston Scientific. Dr. Jakubowski is an employee of Eli Lilly Co. Dr. Neumann reports no personal conflicts, whereas his institution received research grants, consulting fees, or paid advisory board fees and lecture fees from Eli Lilly Co. and Daiichi Sankyo; and lecture fees from AstraZeneca and Sanofi-Aventis. Dr. Müller has reported that she has no relationships relevant to the contents of this paper to disclose.
- Received December 12, 2011.
- Revision received February 10, 2012.
- Accepted February 12, 2012.
- American College of Cardiology Foundation