| Institution: | 1. Department of Cardiology, Deutsches Herzzentrum München, Munich, Germany;2. Technische Universität München, Munich, Germany;3. German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich, Germany;4. Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone, Italy;5. Department of Cardiology and Angiology II, University Heart Center Freiburg – Bad Krozingen, Bad Krozingen, Germany;6. Department of Cardiology, Medical Campus Lake Constance, Friedrichshafen, Germany;7. Medizinische Klinik und Poliklinik Innere Medizin I (Kardiologie, Angiologie, Pneumologie), Klinikum rechts der Isar, Munich, Germany;8. Heart Center Bad Segeberg, Bad Segeberg, Germany;9. Departments of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau, Germany;10. Department of Cardiology, Klinik der Universität München, Ludwig-Maximilians-University, Munich, Germany;11. Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida;12. Heart Center, Campus Kerckhoff of Justus-Liebig-University, Giessen, Germany;13. German Center for Cardiovascular Research, Partner Site Rhine-Main, Frankfurt, Germany;14. Technical University of Munich, School of Medicine, Institute of General Practice and Health Services Research, Munich, Germany |
| Abstract: | ObjectivesThe aim of this study was to assess the efficacy and safety of ticagrelor versus prasugrel in patients with diabetes mellitus (DM) presenting with acute coronary syndromes (ACS) in whom invasive therapy was planned.BackgroundThe efficacy and safety of ticagrelor versus prasugrel in patients with ACS with DM undergoing invasive treatment remain unknown.MethodsThis pre-specified analysis of the ISAR-REACT (Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment) 5 trial included 892 patients with ACS with DM and 3,124 patients with ACS without DM randomized to prasugrel or ticagrelor. The primary endpoint was a composite of death, myocardial infarction, or stroke; the safety endpoint was Bleeding Academic Research Consortium types 3 to 5 bleeding (both assessed 12 months after randomization).ResultsThe primary endpoint occurred in 51 patients (11.2%) in the ticagrelor group and 55 patients (13.0%) in the prasugrel group in the DM cohort (hazard ratio: 0.84; 95% confidence interval: 0.58 to 1.24; p = 0.383) and in 132 patients (8.6%) in the ticagrelor group and 81 patients (5.2%) in the prasugrel group in the non-DM cohort (hazard ratio: 1.70; 95% confidence interval: 1.29 to 2.24; p < 0.001). There was a significant treatment arm–by–diabetic status interaction (pint = 0.0035). Bleeding Academic Research Consortium types 3 to 5 bleeding occurred in 27 patients (6.9%) in the ticagrelor group and 19 patients (5.5%) in the prasugrel group (p = 0.425) in the DM cohort and in 68 patients (5.2%) in the ticagrelor group and 60 patients (4.6%) in the prasugrel group in the non-DM cohort (p = 0.500).ConclusionsDM seems to affect the efficacy of ticagrelor and prasugrel in patients with ACS. In patients with DM, the efficacy of ticagrelor was comparable with that of prasugrel. (Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome ISAR-REACT 5]; NCT01944800) |
