Gjin Ndrepepa1, Adnan Kastrati2, Maurizio Menichelli3, Franz-Josef Neumann4, Jochen Wöhrle5, Isabell Bernlochner6, Gert Richardt7, Bernhard Witzenbichler8, Dirk Sibbing9, Senta Gewalt1, Dominick J Angiolillo10, Christian W Hamm11, Alexander Hapfelmeier12, Dietmar Trenk4, Karl-Ludwig Laugwitz6, Heribert Schunkert13, Stefanie Schüpke13, Katharina Mayer1. 1. Department of Cardiology, Deutsches Herzzentrum München, Munich, Germany; Technische Universität München, Munich, Germany. 2. Department of Cardiology, Deutsches Herzzentrum München, Munich, Germany; Technische Universität München, Munich, Germany; German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich, Germany. Electronic address: kastrati@dhm.mhn.de. 3. Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone, Italy. 4. Department of Cardiology and Angiology II, University Heart Center Freiburg - Bad Krozingen, Bad Krozingen, Germany. 5. Department of Cardiology, Medical Campus Lake Constance, Friedrichshafen, Germany. 6. German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich, Germany; Medizinische Klinik und Poliklinik Innere Medizin I (Kardiologie, Angiologie, Pneumologie), Klinikum rechts der Isar, Munich, Germany. 7. Heart Center Bad Segeberg, Bad Segeberg, Germany. 8. Departments of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau, Germany. 9. German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich, Germany; Department of Cardiology, Klinik der Universität München, Ludwig-Maximilians-University, Munich, Germany. 10. Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida. 11. Heart Center, Campus Kerckhoff of Justus-Liebig-University, Giessen, Germany; German Center for Cardiovascular Research, Partner Site Rhine-Main, Frankfurt, Germany. 12. Technical University of Munich, School of Medicine, Institute of General Practice and Health Services Research, Munich, Germany. 13. Department of Cardiology, Deutsches Herzzentrum München, Munich, Germany; Technische Universität München, Munich, Germany; German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich, Germany.
Abstract
OBJECTIVES: The 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. BACKGROUND: The efficacy and safety of ticagrelor versus prasugrel in patients with ACS with DM undergoing invasive treatment remain unknown. METHODS: This 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 toprasugrel 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). RESULTS: The 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). CONCLUSIONS: DM 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).
RCT Entities:
OBJECTIVES: The 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. BACKGROUND: The efficacy and safety of ticagrelor versus prasugrel in patients with ACS with DM undergoing invasive treatment remain unknown. METHODS: This 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). RESULTS: The 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). CONCLUSIONS:DM 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).
Authors: Ramzi A Ajjan; Noppadol Kietsiriroje; Lina Badimon; Gemma Vilahur; Diana A Gorog; Dominick J Angiolillo; David A Russell; Bianca Rocca; Robert F Storey Journal: Eur Heart J Date: 2021-06-14 Impact factor: 29.983
Authors: Akshyaya Pradhan; Aashish Tiwari; Giuseppe Caminiti; Chiara Salimei; Saverio Muscoli; Rishi Sethi; Marco Alfonso Perrone Journal: Int J Environ Res Public Health Date: 2022-07-23 Impact factor: 4.614