Tullio Palmerini1, Antonio G Bruno1, Martine Gilard2, Marie-Claude Morice3, Marco Valgimigli4, Gilles Montalescot5, Jean-Philippe Collet5, Diego Della Riva1, Maria Letizia Bacchi-Reggiani1, Philippe Gabriel Steg6,7, Abdourahmane Diallo8, Eric Vicaut8, Gerard Helft9,10, Masato Nakamura11, Philippe Généreux11,12, Torsten P Vahl12,13, Gregg W Stone12,13. 1. Dipartimento Cardio-Toraco-Vascolare, University of Bologna, Italy (T.P., A.G.B., D.D.R., M.L.B.-R.). 2. Department of Cardiology, Brest University, France (M.G.). 3. Générale de Santé, Institut Cardiovasculaire Paris Sud, Massy, France (M.-C.M.). 4. Swiss Cardiovascular Center, Bern, Switzerland (M.V.). 5. Sorbonne Université-Paris, France (G.M., J.-P.C.). 6. ACTION Study Group, Institut de Cardiologie, Centre Hospitalier Universitaire Pitié-Salpêtrière, Paris, France (P.G.S.). 7. Hopital Bichat (P.G.S.), Assistance Publique-Hopitaux de Paris, France. 8. Unite de Recherche Clinique Lariboisière St. Louis Hopital Fernand Widal (A.D., E.V.), Assistance Publique-Hopitaux de Paris, France. 9. Institut de Cardiologie, Hopital Pitie-Salpetriere (G.H.), Assistance Publique-Hopitaux de Paris, France. 10. Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan (G.H.). 11. Gagnon Cardiovascular Institute, Morristown Medical Center, NJ (M.N., P.G.). 12. Cardiovascular Research Foundation, New York, NY (P.G., T.P.V., G.W.S.). 13. NewYork-Presbyterian Hospital/Columbia University Medical Center NY (T.P.V., G.W.S.).
Abstract
BACKGROUND: We sought to determine whether the risks and benefits of prolonging dual-antiplatelet therapy (DAPT) beyond 1 year after drug-eluting stent implantation depend on clinical presentation in a meta-analysis of randomized controlled trials. METHODS AND RESULTS: Randomized controlled trials comparing ≤1- versus >1-year DAPT after drug-eluting stent placement were searched through MEDLINE, EMBASE, Cochrane databases, and proceedings of international meetings. The primary efficacy end point was myocardial infarction, whereas the primary safety end point was major bleeding. Net clinical benefit was defined as the composite of myocardial infarction or major bleeding. Outcomes were analyzed according to patient presentation with stable ischemic heart disease versus acute coronary syndromes. The meta-analysis included 6 trials with a total of 21 457 patients, including 14 132 with stable ischemic heart disease and 7325 with acute coronary syndrome. After a median follow-up of 19.5 months, ≤1-year DAPT was associated with higher rates of myocardial infarction compared with >1-year DAPT (hazard ratio [HR], 1.63; 95% CI, 1.37-1.95), with no interaction apparent between treatment effect and clinical presentation. Shorter DAPT was associated with reduced rates of major bleeding compared with longer DAPT (HR, 0.64; 95% CI, 0.42-0.99) with no significant interaction between treatment effect and clinical presentation. However, a net clinical benefit of >1-year DAPT was present in patients with acute coronary syndrome (HR of shorter versus longer DAPT, 1.59; 95% CI, 1.24-2.02) but not in those with stable ischemic heart disease (HR, 1.15; 95% CI, 0.89-1.51; Pinteraction=0.04). Shorter DAPT was also associated with lower rates of noncardiac mortality compared with longer DAPT (HR, 0.71; 95% CI, 0.52-0.96), with no significant interaction between treatment effect and clinical presentation ( Pinteraction=0.12). CONCLUSIONS: Compared with ≤1-year DAPT, >1-year DAPT reduces the risk of myocardial infarction but increases the risk of major bleeding and noncardiac mortality. A net clinical benefit of extended DAPT was apparent for patients with acute coronary syndrome but not for those with stable ischemic heart disease.
BACKGROUND: We sought to determine whether the risks and benefits of prolonging dual-antiplatelet therapy (DAPT) beyond 1 year after drug-eluting stent implantation depend on clinical presentation in a meta-analysis of randomized controlled trials. METHODS AND RESULTS: Randomized controlled trials comparing ≤1- versus >1-year DAPT after drug-eluting stent placement were searched through MEDLINE, EMBASE, Cochrane databases, and proceedings of international meetings. The primary efficacy end point was myocardial infarction, whereas the primary safety end point was major bleeding. Net clinical benefit was defined as the composite of myocardial infarction or major bleeding. Outcomes were analyzed according to patient presentation with stable ischemic heart disease versus acute coronary syndromes. The meta-analysis included 6 trials with a total of 21 457 patients, including 14 132 with stable ischemic heart disease and 7325 with acute coronary syndrome. After a median follow-up of 19.5 months, ≤1-year DAPT was associated with higher rates of myocardial infarction compared with >1-year DAPT (hazard ratio [HR], 1.63; 95% CI, 1.37-1.95), with no interaction apparent between treatment effect and clinical presentation. Shorter DAPT was associated with reduced rates of major bleeding compared with longer DAPT (HR, 0.64; 95% CI, 0.42-0.99) with no significant interaction between treatment effect and clinical presentation. However, a net clinical benefit of >1-year DAPT was present in patients with acute coronary syndrome (HR of shorter versus longer DAPT, 1.59; 95% CI, 1.24-2.02) but not in those with stable ischemic heart disease (HR, 1.15; 95% CI, 0.89-1.51; Pinteraction=0.04). Shorter DAPT was also associated with lower rates of noncardiac mortality compared with longer DAPT (HR, 0.71; 95% CI, 0.52-0.96), with no significant interaction between treatment effect and clinical presentation ( Pinteraction=0.12). CONCLUSIONS: Compared with ≤1-year DAPT, >1-year DAPT reduces the risk of myocardial infarction but increases the risk of major bleeding and noncardiac mortality. A net clinical benefit of extended DAPT was apparent for patients with acute coronary syndrome but not for those with stable ischemic heart disease.