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Randomized comparison of 6- versus 24-month clopidogrel therapy after balancing anti-intimal hyperplasia stent potency in all-comer patients undergoing percutaneous coronary intervention
- Source :
- American Heart Journal. 160:804-811
- Publication Year :
- 2010
- Publisher :
- Elsevier BV, 2010.
-
Abstract
- Background The optimal duration of clopidogrel therapy after coronary stenting is debated because of the scarcity of randomized controlled trials and inconsistencies arising from registry data. Although prolonged clopidogrel therapy after bare metal stenting is regarded as an effective secondary prevention measure, the safety profile of drug-eluting stents itself has been questioned in patients not receiving ≥12 months of dual-antiplatelet therapy. Hypothesis Twenty-four months of clopidogrel therapy after coronary stenting reduces the composite of death, myocardial infarction, or stroke compared with 6 months of treatment. Study design PRODIGY is an unblinded, multicenter, 4-by-2 randomized trial. All-comer patients with indication to coronary stenting are randomly treated— balancing randomization —with bare metal stent (no active late loss inhibition), Endeavor Sprint zotarolimus-eluting stent (Medtronic, Santa Rosa, CA) (mild late loss inhibition), Taxus paclitaxel-eluting stent (Boston Scientific, Natick, MA) (moderate late loss inhibition), or Xience V everolimus-eluting stent (Abbott Vascular, Santa Clara, CA) (high late loss inhibition). At 30 days, patients in each stent group are randomly allocated to receive 24 or up to 6 months of clopidogrel therapy― primary end point randomization . With 1,700 individuals, this study will have >80% power to detect a 40% difference in the primary end point after sample size augmentation of 5% and a background event rate of 8%. Summary The PRODIGY trial aims to assess whether 24 months of clopidogrel therapy improves cardiovascular outcomes after coronary intervention in a broad all-comer patient population receiving a balanced mixture of stents with various anti-intimal hyperplasia potency.
- Subjects :
- Bare-metal stent
medicine.medical_specialty
business.industry
medicine.medical_treatment
Stent
Percutaneous coronary intervention
equipment and supplies
Clopidogrel
Surgery
law.invention
Randomized controlled trial
law
Angioplasty
medicine
Platelet aggregation inhibitor
cardiovascular diseases
Ticlopidine
Cardiology and Cardiovascular Medicine
business
medicine.drug
Subjects
Details
- ISSN :
- 00028703
- Volume :
- 160
- Database :
- OpenAIRE
- Journal :
- American Heart Journal
- Accession number :
- edsair.doi...........561fe102105b4b6fd3140178d52dc37a