Stefano Savonitto1, Luca A Ferri2, Luigi Piatti2, Daniele Grosseto3, Giancarlo Piovaccari3, Nuccia Morici4, Irene Bossi4, Paolo Sganzerla5, Giovanni Tortorella6, Michele Cacucci7, Maurizio Ferrario8, Ernesto Murena9, Girolamo Sibilio9, Stefano Tondi10, Anna Toso11, Sergio Bongioanni12, Amelia Ravera13, Elena Corrada14, Matteo Mariani15, Leonardo Di Ascenzo16, A Sonia Petronio17, Claudio Cavallini18, Giancarlo Vitrella, Renata Rogacka19, Roberto Antonicelli20, Bruno M Cesana21, Leonardo De Luca22, Filippo Ottani23, Giuseppe De Luca24, Federico Piscione25, Nadia Moffa26, Stefano De Servi27. 1. Ospedale Manzoni, Lecco, Italy (S.S., L.A.F., L.P.). s.savonitto@asst-lecco.it. 2. Ospedale Manzoni, Lecco, Italy (S.S., L.A.F., L.P.). 3. Ospedale Infermi, Rimini, Italy (D.G., G.P.). 4. Azienda Socio-Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milano, Italy (N. Morici, I.B.). 5. Ospedale Treviglio-Caravaggio, Treviglio, Italy (P.S.). 6. Istituto di Ricerca e Cura a Carattere Scientifico Arcispedale S. Maria Nuova, Reggio Emilia, Italy (G.T.). 7. Ospedale Maggiore, Crema, Italy (M.C.). 8. IRCCS Fondazione Policlinico S. Matteo, Pavia, Italy (M.F.). 9. Ospedale S. Maria delle Grazie, Pozzuoli, Italy (E.M., G.S.). 10. Ospedale Baggiovara, Modena, Italy (S.T.). 11. Ospedale S. Stefano, Prato, Italy (A.T.). 12. Ospedale Mauriziano, Torino, Italy (S.B.). 13. Ospedale Ruggi D' Aragona, Salerno, Italy (A.R.). 14. Humanitas Clinical and Research Center, Rozzano, Italy (E.C.). 15. Ospedale Civile, Legnano, Italy (M.M.). 16. Ospedale di San Donà di Piave-Portogruaro, Portogruaro, Italy (L.D.A.). 17. Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy (A.S.P.). 18. Ospedale S. Maria della Misericordia, Perugia, Italy (C.C.). 19. Azienda Ospedaliera di Desio e Vimercate, Desio, Italy (R.R.). 20. Istituto Nazionale di Ricerca e Cura per l' Anziano, Ancona, Italy (R.A.). 21. Statistics and Biomathematics Unit, Department of Molecular and Transactional Medicine, University of Brescia, Italy (B.M.C.). 22. San Giovanni Evangelista Hospital, Tivoli, Italy (L.D.L.). 23. Ospedale Morgagni Pierantoni, Forlì, Italy (F.O.). 24. Azienda Ospedaliera-Universitaria "Maggiore della Carità," Eastern Piedmont University, Novara, Italy (G.D.L.). 25. Department of Medicine, Surgery and Dentistry-Schola Medica Salernitana, University of Salerno, Italy (F.P.). 26. Mediolanum Cardio Research, Milan, Italy (N. Moffa). 27. Multimedica IRCSS, Milan, Italy (S.D.S.).
Abstract
BACKGROUND:Elderly patients are at elevated risk of both ischemic and bleeding complications after an acute coronary syndrome and display higher on-clopidogrel platelet reactivity compared with younger patients. Prasugrel 5 mg provides more predictable platelet inhibition compared with clopidogrel in the elderly, suggesting the possibility of reducing ischemic events without increasing bleeding. METHODS: In a multicenter, randomized, open-label, blinded end point trial, we compared a once-daily maintenance dose of prasugrel 5 mg with the standard clopidogrel 75 mg in patients >74 years of age with acute coronary syndrome undergoing percutaneous coronary intervention. The primary end point was the composite of mortality, myocardial infarction, disabling stroke, and rehospitalization for cardiovascular causes or bleeding within 1 year. The study was designed to demonstrate superiority of prasugrel 5 mg over clopidogrel 75 mg. RESULTS: Enrollment was interrupted, according to prespecified criteria, after a planned interim analysis, when 1443 patients (40% women; mean age, 80 years) had been enrolled with a median follow-up of 12 months, because of futility for efficacy. The primary end point occurred in 121 patients (17%) with prasugrel and 121 (16.6%) with clopidogrel (hazard ratio, 1.007; 95% confidence interval, 0.78-1.30; P=0.955). Definite/probable stent thrombosis rates were 0.7% with prasugrel versus 1.9% with clopidogrel (odds ratio, 0.36; 95% confidence interval, 0.13-1.00; P=0.06). Bleeding Academic Research Consortium types 2 and greater rates were 4.1% with prasugrel versus 2.7% with clopidogrel (odds ratio, 1.52; 95% confidence interval, 0.85-3.16; P=0.18). CONCLUSIONS: The present study in elderly patients with acute coronary syndromes showed no difference in the primary end point between reduced-dose prasugrel and standard-dose clopidogrel. However, the study should be interpreted in light of the premature termination of the trial. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01777503.
RCT Entities:
BACKGROUND: Elderly patients are at elevated risk of both ischemic and bleeding complications after an acute coronary syndrome and display higher on-clopidogrel platelet reactivity compared with younger patients. Prasugrel 5 mg provides more predictable platelet inhibition compared with clopidogrel in the elderly, suggesting the possibility of reducing ischemic events without increasing bleeding. METHODS: In a multicenter, randomized, open-label, blinded end point trial, we compared a once-daily maintenance dose of prasugrel 5 mg with the standard clopidogrel 75 mg in patients >74 years of age with acute coronary syndrome undergoing percutaneous coronary intervention. The primary end point was the composite of mortality, myocardial infarction, disabling stroke, and rehospitalization for cardiovascular causes or bleeding within 1 year. The study was designed to demonstrate superiority of prasugrel 5 mg over clopidogrel 75 mg. RESULTS: Enrollment was interrupted, according to prespecified criteria, after a planned interim analysis, when 1443 patients (40% women; mean age, 80 years) had been enrolled with a median follow-up of 12 months, because of futility for efficacy. The primary end point occurred in 121 patients (17%) with prasugrel and 121 (16.6%) with clopidogrel (hazard ratio, 1.007; 95% confidence interval, 0.78-1.30; P=0.955). Definite/probable stent thrombosis rates were 0.7% with prasugrel versus 1.9% with clopidogrel (odds ratio, 0.36; 95% confidence interval, 0.13-1.00; P=0.06). Bleeding Academic Research Consortium types 2 and greater rates were 4.1% with prasugrel versus 2.7% with clopidogrel (odds ratio, 1.52; 95% confidence interval, 0.85-3.16; P=0.18). CONCLUSIONS: The present study in elderly patients with acute coronary syndromes showed no difference in the primary end point between reduced-dose prasugrel and standard-dose clopidogrel. However, the study should be interpreted in light of the premature termination of the trial. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01777503.
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