• Martine Gilard, Paul Barragan, Arif A L Noryani, Hussam A Noor, Talib Majwal, Thomas Hovasse, Philippe Castellant, Michel Schneeberger, Luc Maillard, Erwan Bressolette, Jaroslaw Wojcik, Nicolas Delarche, Didier Blanchard, Bernard Jouve, Olivier Ormezzano, Franck Paganelli, Gilles Levy, Joël Sainsous, Didier Carrie, Alain Furber, Jacques Berland, Oliver Darremont, Hervé Le Breton, Anne Lyuycx-Bore, Antoine Gommeaux, Claude Cassat, Alain Kermarrec, Pierre Cazaux, Philippe Druelles, Raphael Dauphin, Jean Armengaud, Patrick Dupouy, Didier Champagnac, Patrick Ohlmann, Knut Endresen, Hakim Benamer, Robert Gabor Kiss, Imre Ungi, Jacques Boschat, and Marie-Claude Morice.
• Department of Cardiology, Brest University, Brest, France. Electronic address: Martine.gilard@chu-brest.fr.
• J. Am. Coll. Cardiol. 2015 Mar 3;65(8):777-86.

BackgroundThe currently recommended duration of dual antiplatelet therapy (DAPT) in drug-eluting stent (DES) recipients is 12 months to reduce the risk of late stent thrombosis, particularly in those with acute coronary syndrome (ACS).ObjectivesThis study hypothesized that antiplatelet treatment with DAPT for 6 months may be noninferior to 24-month DAPT in aspirin-sensitive patients.MethodsA multicenter, randomized study assigned patients undergoing implantation of everolimus-eluting stents with confirmed nonresistance to aspirin to receive 6- or 24-month DAPT. The primary endpoint was a composite of death, myocardial infarction, urgent target vessel revascularization, stroke, and major bleeding at 12 months post-stenting.ResultsA total of 2,031 patients were enrolled in 70 European and Middle Eastern centers. The trial was prematurely terminated due to recruitment problems, leaving 941 patients randomized to 24-month DAPT and 953 to 6-month DAPT. The 2 treatment groups had similar baseline and procedural characteristics. There was no significant difference in the primary endpoint (24-month: 1.5% vs. 6-month: 1.6%; p = 0.85). Noninferiority was demonstrated for 6- versus 24-month DAPT, with an absolute risk difference of 0.11% (95% confidence interval: -1.04% to 1.26%; p for noninferiority = 0.0002). There were no significant differences in stent thrombosis or bleeding complications. In the 792 (44%) high-risk patients with ACS, primary and secondary endpoints did not significantly differ (hazard ratio: 1.7 [95% confidence interval: 0.519 to 6.057; p = 0.361]).ConclusionsRates of bleeding and thrombotic events were not significantly different according to 6- versus 24-month DAPT after PCI with new-generation DES in good aspirin responders. (Is There A LIfe for DES After Discontinuation of Clopidogrel [ITALICplus]; NCT01476020).Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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