Martine Gilard1, Paul Barragan2, Arif A L Noryani3, Hussam A Noor4, Talib Majwal5, Thomas Hovasse6, Philippe Castellant7, Michel Schneeberger8, Luc Maillard9, Erwan Bressolette10, Jaroslaw Wojcik11, Nicolas Delarche12, Didier Blanchard13, Bernard Jouve14, Olivier Ormezzano15, Franck Paganelli16, Gilles Levy17, Joël Sainsous18, Didier Carrie19, Alain Furber20, Jacques Berland21, Oliver Darremont22, Hervé Le Breton23, Anne Lyuycx-Bore24, Antoine Gommeaux25, Claude Cassat26, Alain Kermarrec27, Pierre Cazaux28, Philippe Druelles29, Raphael Dauphin30, Jean Armengaud31, Patrick Dupouy32, Didier Champagnac33, Patrick Ohlmann34, Knut Endresen35, Hakim Benamer36, Robert Gabor Kiss37, Imre Ungi38, Jacques Boschat7, Marie-Claude Morice6. 1. Department of Cardiology, Brest University, Brest, France. Electronic address: Martine.gilard@chu-brest.fr. 2. Polyclinique les Fleurs, Ollioules, France. 3. Al Qassimi Hospital, Sharjah, United Arab Emirates. 4. Bahrain Defence Force West, Riffa, Bahrain. 5. Dubai Hospital, Dubai, United Arab Emirates. 6. Générale de Santé, Institut Cardiovasculaire Paris Sud, Massy, France. 7. Department of Cardiology, Brest University, Brest, France. 8. Hôpital Albert Schweitzer, Colmar, France. 9. Clinique Axium, Aix en Provence, France. 10. Nouvelles Cliniques Nantaises, Nantes, France. 11. Klinika Kardiologii SPSK4, Lublin, Poland. 12. Centre Hospitalier Mitterrand, Pau, France. 13. Clinique Saint Gatien, Tours, France. 14. Centre Hospitalier, Aix en Provence, France. 15. Centre Hospitalier Universitaire de Grenoble, Grenoble, France. 16. Centre Hospitalier Universitaire, Hôpital Nord, Marseille, France. 17. Clinique du Millénaire, Montpellier, France. 18. Clinique Rhône Durance, Avignon, France. 19. Centre Hospitalier Universitaire, Toulouse, France. 20. Centre Hospitalier Universitaire, Angers, France. 21. Clinique Saint Hilaire, Rouen, France. 22. Clinique Saint Augustin, Bordeaux, France. 23. Centre Hospitalier Universitaire, Rennes, France. 24. Centre Hospitalier, Compiègne, France. 25. Polyclinique de Bois, Bernard, France. 26. Centre Hospitalier Universitaire, Limoges, France. 27. Centre Hospitalier, Vannes, France. 28. Centre Hospitalier, Lorient, France. 29. Poly de Saint Laurent, Rennes, France. 30. Hôpital de la Croix Rousse, Lyon France. 31. Clinique Esquirol, Agen, France. 32. Hôpital Privé, Antony, France. 33. Clinique Tonkin, Villeurbanne, France. 34. Centre Hospitalier Universitaire, Strasbourg, France. 35. Oslo Universitetssykehus, Oslo, Norway. 36. Hôpital La Roseraie, Aubervilliers, France. 37. MH Egrszsegugyi Kozpont, Budapest, Hungary. 38. Honvéd Kórház, Budapest, Hungary, and University of Szeged, Szent-Györgyi Albert, Szeged, Hungary.
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). OBJECTIVES: 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 toaspirin 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).
RCT Entities:
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). OBJECTIVES: 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).