6- Versus 24-Month Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stents in Patients Nonresistant to Aspirin

Autor: Didier Blanchard, Franck Paganelli, Didier Champagnac, Hervé Le Breton, Patrick Dupouy, Raphael Dauphin, Philippe Castellant, Nicolas Delarche, Anne Lyuycx-Bore, Luc Maillard, Róbert Gábor Kiss, Philippe Druelles, Antoine Gommeaux, Jarosław Wójcik, Marie Claude Morice, Michel Schneeberger, Erwan Bressolette, Alain Kermarrec, Joel Sainsous, Paul Barragan, Romain Didier, Olivier Darremont, Hakim Ben Amer, Gilles Levy, Alain Furber, Thomas Hovasse, Martine Gilard, Bernard Jouve, Jacques Berlan, Irme Ungi, Patrick Ohlmann, Jean Armengaud, Talib Majwal, Pierre Cazaux, Arif A.L. Noryani, Claude Cassat, O. Ormezzano, Didier Carrié, Hussam A. Noor
Přispěvatelé: Centre Hospitalier Universitaire [Grenoble] (CHU), Vascular research center of Marseille (VRCM), Institut National de la Santé et de la Recherche Médicale (INSERM)-Aix Marseille Université (AMU)
Rok vydání: 2017
Předmět:
Zdroj: JACC: Cardiovascular Interventions
JACC: Cardiovascular Interventions, Elsevier/American College of Cardiology, 2017, 10 (12), pp.1202-1210. ⟨10.1016/j.jcin.2017.03.049⟩
ISSN: 1936-8798
DOI: 10.1016/j.jcin.2017.03.049
Popis: Objectives The aim of this study was to test the hypothesis that 6-month dual antiplatelet therapy (DAPT) is noninferior to 24-month DAPT in aspirin-sensitive patients. Background The ITALIC (Is There a Life for DES After Discontinuation of Clopidogrel) trial showed that rates of bleeding and thrombotic events at 1 year were much the same with 6 versus 12 months of DAPT after percutaneous coronary intervention with second-generation drug-eluting stents. In this report, 2-year follow-up is presented. Methods In a multicenter randomized study, patients with confirmed nonresistance to aspirin undergoing drug-eluting stent implantation were allocated to 6 or 24 months of DAPT. The primary endpoint was a composite of death, myocardial infarction, urgent target vessel revascularization, stroke, and major bleeding at 12 months post–percutaneous coronary intervention. The secondary endpoints comprised the same composite endpoint at 24 months and each individual component. Results Overall, 2,031 patients from 70 centers were screened; 926 were randomized to 6-month and 924 to 24-month DAPT. Noninferiority was demonstrated for 6- versus 12-month DAPT, with an absolute risk difference of 0.11% (95% confidence interval: −1.04% to 1.26%; p = 0.0002). At 2 years, the composite endpoint was unchanged, at 3.5% for 6 months and 3.7% for 24 months (p = 0.79), and rates of myocardial infarction (1.3% vs. 1.0%; p = 0.51), stroke (0.6% vs. 0.8%; p = 0.77), and target vessel revascularization (1.0% vs. 0.3%; p = 0.09) were likewise similar. There was a trend toward higher mortality with longer DAPT (2.2% vs. 1.2%; p = 0.11). Four patients (0.4%) in the 24-month group and none in the 6-month group had major bleeding. Conclusions Two-year outcomes in the ITALIC trial confirmed the 1-year results and showed that patients receiving 6-month DAPT after percutaneous coronary intervention with second-generation drug-eluting stent have similar outcomes to those receiving 24-month DAPT.
Databáze: OpenAIRE