Author + information
- Received November 28, 2016
- Revision received March 28, 2017
- Accepted March 30, 2017
- Published online June 19, 2017.
- Romain Didier, MDa,
- Marie Claude Morice, MDb,
- Paul Barragan, MDc,
- Arif A.L. Noryani, MDd,
- Hussam A. Noor, MDe,
- Talib Majwal, MDf,
- Thomas Hovasse, MDb,
- Philippe Castellant, MDa,
- Michel Schneeberger, MDg,
- Luc Maillard, MD, PhDh,
- Erwan Bressolette, MDi,
- Jaroslaw Wojcik, MDj,
- Nicolas Delarche, MDk,
- Didier Blanchard, MDl,
- Bernard Jouve, MDm,
- Olivier Ormezzano, MDn,
- Franck Paganelli, MDo,
- Gilles Levy, MDp,
- Joël Sainsous, MDq,
- Didier Carrie, MDr,
- Alain Furber, MD, PhDs,
- Jacques Berlan, MDt,
- Olivier Darremont, MDu,
- Hervé Le Breton, MDv,
- Anne Lyuycx-Bore, MDw,
- Antoine Gommeaux, MDx,
- Claude Cassat, MDy,
- Alain Kermarrec, MDz,
- Pierre Cazaux, MDaa,
- Philippe Druelles, MDbb,
- Raphael Dauphin, MDcc,
- Jean Armengaud, MDdd,
- Patrick Dupouy, MDee,
- Didier Champagnac, MDff,
- Patrick Ohlmann, MDgg,
- Hakim Ben Amer, MDhh,
- Robert G. Kiss, MDii,
- Irme Ungi, MDjj and
- Martine Gilard, MD, PhDa,∗ ()
- aDepartment of Cardiology Brest University, Brest, France
- bICPS, Massy, France
- cClinique des Fleurs, Ollioules, France
- dAl Qassimi Hospital, Sharjah, United Arab Emirates
- eBahrain Defence Force, West Riffa, Bahrain
- fDubai Hospital, Dubai, United Arab Emirates
- gHôpital Albert Schweitzer, Colmar, France
- hClinique Axium, Aix en Provence, France
- iNCN, Nantes, France
- jKlinika Kardiologii SPSK4, Lublin, Poland
- kCH Mitterrand, Pau, France
- lClinique St. Gatien, Tours, France
- mCH Aix en Provence, Aix en Provence, France
- nCHU, Grenoble, France
- oCHU Hôpital Nord, Marseille, France
- pClinique du Millénaire, Montpellier, France
- qClinique Rhône Durance, Avignon, France
- rCHU, Toulouse, France
- sCHU, Angers, France
- tClinique St. Hilaire, Rouen, France
- uClinique Saint Augustin, Bordeaux, France
- vCHU, Rennes, France
- wCH Compiègne, Compiègne, France
- xPolyclinique de Bois, Bernard, France
- yCHU, Limoges, France
- zCH Vannes, Vannes, France
- aaCH Lorient, Lorient, France
- bbPoly de St. Laurent, Rennes, France
- ccHôpital de la Croix Rousse, Lyon, France
- ddClinique Esquirol, Agen, France
- eeHôpital Privé, Antony, France
- ffClinique Tonkin, Villeurbanne, France
- ggCHU, Strasbourg, France
- hhHôpital la Roseraie, Aubervilliers, France
- iiHonvéd Kórház, Budapest, Hungary
- jjSZTE Szent-Györgyi Albert, Szeged, Hungary
- ↵∗Address for correspondence:
Prof. Martine Gilard, Département de Cardiologie, CHU de la Cavale Blanche, Boulevard Tanguy Prigent, 29609 Brest Cedex, France.
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.
This study was conducted by the French Society of Cardiology. Funding was provided by Abbott Vascular Devices. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received November 28, 2016.
- Revision received March 28, 2017.
- Accepted March 30, 2017.
- 2017 American College of Cardiology Foundation
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