Six-month versus 24-month dual antiplatelet therapy after implantation of drug eluting stents in patients non-resistant to aspirin: ITALIC, a randomized multicenter trial.
J Am Coll Cardiol. 2014 Nov 16;
Authors: Gilard M, Barragan P, Noryani AA, Noor HA, Majwal T, Hovasse T, Castellant P, Schneeberger M, Maillard L, Bressolette E E, Wojcik J, Delarche N, Blanchard D, Jouve B, Ormezzano O, Paganelli F, Levy G, Sainsous J, Carrie D, Furber A, Berland J, Darremont O, Le Breton H, Lyuycx-Bore A, Gommeaux A, Cassat C, Kermarrec A, Cazaux P, Druelles P, Dauphin R, Armengaud J, Dupouy P, Champagnac D, Ohlmann P, Endresen K K, Benamer H, Kiss RG, Ungi I, Boschat J J, Morice MC
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 acute coronary syndrome.
OBJECTIVES: It was hypothesized that antiplatelet treatment with DAPT for 6 versus may be non-inferior to DAPT for 24 months in aspirin-sensitive patients METHODS: A multicenter, randomized study assigned patients undergoing implantation of Xience V (Abbott vascular) to receive 6- or 24-month DAPT with confirmed non-resistance to aspirin. The primary endpoint was a composite of death, myocardial infarction, urgent target vessel revascularization, stroke and major bleeding at 12 months post-stenting.
RESULTS: 2,031 patients were enrolled in 70 European and Middle East centers. The trial was prematurely terminated due to problems with recruitment. 941 patients were randomized to 24 month-DAPT and 953 to 6 month-DAPT; 137 patients were resistant to aspirin. The two treatment groups had similar baseline and procedural characteristics. There was no significant difference between the 2 treatment groups regarding the primary endpoint (1.5 vs. 1.6%, p=0.85), even in high-risk (ACS) patients. Non-inferiority was demonstrated for 6-month versus 24-month DAPT, with an absolute risk difference of 0.11% (95% CI: -1.04 to 1.26; p for non-inferiority = 0.0002). There were no significant differences in stent thrombosis and in bleeding complications. In the 792 (44%) high-risk patients with ACS, primary and secondary endpoints did not significantly differ 1.7% [95% CI: 0.519 to 6.057; p=0.361]. Interaction between DAPT duration and ACS was non significant (p=0.305).
CONCLUSION: The ITALIC trial showed that rates of bleeding and of thrombotic events were not significantly different according to 6- versus 24-month DAPT after PCI with new-generation DES in good aspirin responders.
CLINICAL TRIAL INFO: ITALIC: Is There A LIfe for DES after discontinuation of Clopidogrel NCT01476020.
PMID: 25461690 [PubMed - as supplied by publisher]