title: 6- versus 24-month dual antiplatelet therapy after implantation of drug-eluting stents in patients nonresistant to aspirin: the randomized, multicenter ITALIC trial.
abstract: BACKGROUND
  The 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).
  
  
  OBJECTIVE
  This study hypothesized that antiplatelet treatment with DAPT for 6 months may be noninferior to 24-month DAPT in aspirin-sensitive patients.
  
  
  METHODS
  A 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.
  
  
  RESULTS
  A 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]).
  
  
  CONCLUSIONS
  Rates 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).
authors.affiliation: Department of Cardiology, Brest University, Brest, France. Electronic address: Martine.gilard@chu-brest.fr.
authors.forename: Martine
authors.initials: M
authors.lastname: Gilard
authors.affiliation: Polyclinique les Fleurs, Ollioules, France.
authors.forename: Paul
authors.initials: P
authors.lastname: Barragan
authors.affiliation: Al Qassimi Hospital, Sharjah, United Arab Emirates.
authors.forename: Arif A L
authors.initials: AAL
authors.lastname: Noryani
authors.affiliation: Bahrain Defence Force West, Riffa, Bahrain.
authors.forename: Hussam A
authors.initials: HA
authors.lastname: Noor
authors.affiliation: Dubai Hospital, Dubai, United Arab Emirates.
authors.forename: Talib
authors.initials: T
authors.lastname: Majwal
authors.affiliation: Générale de Santé, Institut Cardiovasculaire Paris Sud, Massy, France.
authors.forename: Thomas
authors.initials: T
authors.lastname: Hovasse
authors.affiliation: Department of Cardiology, Brest University, Brest, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Castellant
authors.affiliation: Hôpital Albert Schweitzer, Colmar, France.
authors.forename: Michel
authors.initials: M
authors.lastname: Schneeberger
authors.affiliation: Clinique Axium, Aix en Provence, France.
authors.forename: Luc
authors.initials: L
authors.lastname: Maillard
authors.affiliation: Nouvelles Cliniques Nantaises, Nantes, France.
authors.forename: Erwan
authors.initials: E
authors.lastname: Bressolette
authors.affiliation: Klinika Kardiologii SPSK4, Lublin, Poland.
authors.forename: Jaroslaw
authors.initials: J
authors.lastname: Wojcik
authors.affiliation: Centre Hospitalier Mitterrand, Pau, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Delarche
authors.affiliation: Clinique Saint Gatien, Tours, France.
authors.forename: Didier
authors.initials: D
authors.lastname: Blanchard
authors.affiliation: Centre Hospitalier, Aix en Provence, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Jouve
authors.affiliation: Centre Hospitalier Universitaire de Grenoble, Grenoble, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Ormezzano
authors.affiliation: Centre Hospitalier Universitaire, Hôpital Nord, Marseille, France.
authors.forename: Franck
authors.initials: F
authors.lastname: Paganelli
authors.affiliation: Clinique du Millénaire, Montpellier, France.
authors.forename: Gilles
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authors.lastname: Levy
authors.affiliation: Clinique Rhône Durance, Avignon, France.
authors.forename: Joël
authors.initials: J
authors.lastname: Sainsous
authors.affiliation: Centre Hospitalier Universitaire, Toulouse, France.
authors.forename: Didier
authors.initials: D
authors.lastname: Carrie
authors.affiliation: Centre Hospitalier Universitaire, Angers, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Furber
authors.affiliation: Clinique Saint Hilaire, Rouen, France.
authors.forename: Jacques
authors.initials: J
authors.lastname: Berland
authors.affiliation: Clinique Saint Augustin, Bordeaux, France.
authors.forename: Oliver
authors.initials: O
authors.lastname: Darremont
authors.affiliation: Centre Hospitalier Universitaire, Rennes, France.
authors.forename: Hervé
authors.initials: H
authors.lastname: Le Breton
authors.affiliation: Centre Hospitalier, Compiègne, France.
authors.forename: Anne
authors.initials: A
authors.lastname: Lyuycx-Bore
authors.affiliation: Polyclinique de Bois, Bernard, France.
authors.forename: Antoine
authors.initials: A
authors.lastname: Gommeaux
authors.affiliation: Centre Hospitalier Universitaire, Limoges, France.
authors.forename: Claude
authors.initials: C
authors.lastname: Cassat
authors.affiliation: Centre Hospitalier, Vannes, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Kermarrec
authors.affiliation: Centre Hospitalier, Lorient, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Cazaux
authors.affiliation: Poly de Saint Laurent, Rennes, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Druelles
authors.affiliation: Hôpital de la Croix Rousse, Lyon France.
authors.forename: Raphael
authors.initials: R
authors.lastname: Dauphin
authors.affiliation: Clinique Esquirol, Agen, France.
authors.forename: Jean
authors.initials: J
authors.lastname: Armengaud
authors.affiliation: Hôpital Privé, Antony, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Dupouy
authors.affiliation: Clinique Tonkin, Villeurbanne, France.
authors.forename: Didier
authors.initials: D
authors.lastname: Champagnac
authors.affiliation: Centre Hospitalier Universitaire, Strasbourg, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Ohlmann
authors.affiliation: Oslo Universitetssykehus, Oslo, Norway.
authors.forename: Knut
authors.initials: K
authors.lastname: Endresen
authors.affiliation: Hôpital La Roseraie, Aubervilliers, France.
authors.forename: Hakim
authors.initials: H
authors.lastname: Benamer
authors.affiliation: MH Egrszsegugyi Kozpont, Budapest, Hungary.
authors.forename: Robert Gabor
authors.initials: RG
authors.lastname: Kiss
authors.affiliation: Honvéd Kórház, Budapest, Hungary, and University of Szeged, Szent-Györgyi Albert, Szeged, Hungary.
authors.forename: Imre
authors.initials: I
authors.lastname: Ungi
authors.affiliation: Department of Cardiology, Brest University, Brest, France.
authors.forename: Jacques
authors.initials: J
authors.lastname: Boschat
authors.affiliation: Générale de Santé, Institut Cardiovasculaire Paris Sud, Massy, France.
authors.forename: Marie-Claude
authors.initials: MC
authors.lastname: Morice
mesh_terms: D000368:Aged; D001241:Aspirin / Q000008:administration & dosage / Q000009:adverse effects; D000077144:Clopidogrel; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D023903:Coronary Restenosis / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control; D003331:Coronary Vessels / Q000473:pathology / Q000601:surgery; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D057239:Early Termination of Clinical Trials; D005060:Europe; D000068338:Everolimus; D005260:Female; D006470:Hemorrhage / Q000209:etiology / Q000517:prevention & control; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D008877:Middle East; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000379:methods; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D011183:Postoperative Complications / Q000175:diagnosis / Q000517:prevention & control; D020123:Sirolimus / Q000031:analogs & derivatives / Q000627:therapeutic use; D013988:Ticlopidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D010975:Platelet Aggregation Inhibitors; D000068338:Everolimus; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin; D020123:Sirolimus
keywords: double antiplatelet duration; percutaneous coronary angioplasty