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
Open accessAbstract
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 P2Y(12) 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.
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Several large randomized trials found no clinical benefit from adjusting antithrombotic regimens according to platelet function testing.
“Despite initial enthusiasm, multiple large, randomized studies have failed to show any clinical benefit when antithrombotic regimens are adjusted on the basis of platelet function testing.60–62”
From Clinical management of stable coronary artery disease in patients with type 2 diabetes mellitus: a scientific statement from the American Heart Association (2020) · cites this paper as [61]
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- Authors
- Trenk, D., Stone, G. W., Gawaz, M., Kastrati, A., Angiolillo, D. J., Müller, U., Richardt, G., Jakubowski, J. A., & Neumann, F.-J.
- Affiliations
- Universitäts-Herzzentrum Freiburg-Bad Krozingen (DE)
- Columbia University Irving Medical Center (US)
- Universitätsklinikum Tübingen (DE)
- Deutsches Herzzentrum München (DE)
- University of Florida (US)
- Segeberger Kliniken (DE)
- Eli Lilly (United States) (US)
- Corresponding author
- Trenk, Dietmar
- ORCID
- Venue
- Journal of the American College of Cardiology
- Publisher
- Elsevier BV
- Published
- 2012-06
- Volume
- 59
- Issue
- 24
- Pages
- 2159-2164
- ISSN
- 0735-1097 (ISSN-L)
- OpenAlex
- W144700851
- Cited by
- 626
- References
- 15
- Citations by year
- 2026: 8 · 2025: 13 · 2024: 20 · 2023: 21 · 2022: 24 · 2021: 27 · 2020: 27 · 2019: 31 · 2018: 50 · 2017: 49 · 2016: 47 · 2015: 85 · 2014: 75 · 2013: 100 · 2012: 46
- FWCI
- 62.99
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Journal of the American College of Cardiology (publishedVersion)
- PubMed (publishedVersion)
- mediaTUM – the media and publications repository of the Technical University Munich (Technical University Munich) (submittedVersion)
- Funders
- Bristol-Myers Squibb
- Sanofi-Aventis
- GlaxoSmithKline
- Otsuka
- Eli Lilly Co.
- Daiichi Sankyo
- The Medicines Company
- Portola
- Accumetrics
- Schering-Plough
- AstraZeneca
- Eisai
- Boston Scientific
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Antiplatelet Therapy and Cardiovascular Diseases
- Health Sciences › Medicine › Surgery › Coronary Interventions and Diagnostics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Acute Myocardial Infarction Research
- Keywords
- prasugrel, clopidogrel, high on-treatment platelet reactivity, percutaneous coronary intervention, drug-eluting stents, stable coronary artery disease, antiplatelet therapy, P2Y12 inhibition, VerifyNow assay, major bleeding, cardiovascular mortality, myocardial infarction, futility
- MeSH terms
- Prasugrel Hydrochloride, Clopidogrel, Aged, Blood Platelets, Coronary Artery Disease, Female, Humans, Male, Middle Aged, Piperazines, Platelet Aggregation Inhibitors, Thiophenes, Ticlopidine, Angioplasty, Balloon, Coronary, Purinergic P2Y Receptor Antagonists
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