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Short vs. Long Term Duration of Dual Antiplatelet Therapy in Patients treated for In-stent Restenosis. A PRODIGY Trial substudy.
J Am Coll Cardiol. 2013 Oct 10;
Authors: Campo G, Tebaldi M, Vranckx P, Biscaglia S, Tumscitz C, Ferrari R, Valgimigli M
Abstract
OBJECTIVES: To investigate the clinical outcome of patients treated with percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) randomized to short (6 months) vs. long (24 months) dual antiplatelet therapy (DAPT) regimen.
BACKGROUND: It is still unclear if patients treated for ISR may benefit from a long DAPT regimen.
METHODS: For the present purpose we selected 224 patients undergoing PCI procedure for ISR enrolled in the Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia (PRODIGY) trial and randomized short (6 months) vs. long (24 months) DAPT regimen. The primary objective was the cumulative incidence of death, nonfatal myocardial infarction (MI), or cerebrovascular accident at 24 months. Safety endpoints were moderate and major bleeding complications.
RESULTS: Overall, 114 patients were allocated to short DAPT regimen, whereas 110 patients to long DAPT regimen. Twenty-seven patients reached the primary endpoint (19 in short DAPT regimen vs. 8 in long DAPT regimen, p=0.02). The cumulative incidence of the primary endpoint at 24 months was 16.7% in the short DAPT regimen group compared with 7.3% in the long DAPT regimen group (p=0.034). This is principally due to a lower occurrence of death and MI in the long DAPT regimen group as compared to the short DAPT regimen group (6.5% vs. 15.5%, p=0.03). There was no difference in the occurrence of bleeding complications between long vs. short DAPT regimen.
CONCLUSIONS: Our study offers preliminary evidence that patients receiving a new PCI procedure for ISR may benefit from a long-term administration of aspirin plus clopidogrel. Clinical trialinfo: PRODIGY; NCT00611286.
PMID: 24161321 [PubMed - as supplied by publisher]