Ticagrelor or Prasugrel in Patients with Acute Coronary Syndromes.

Gjin Ndrepepa, Helge Möllmann, Willibald Hochholzer, Angela Migliorini, Salvatore Cassese, Pasquale Mollo, Erion Xhepa, Sebastian Kufner, Axel Strehle, Stefan Leggewie, Abdelhakim Allali, Rainer Okrojek, Helmut Schühlen, Dominick J Angiolillo, Christian W Hamm, Alexander Hapfelmeier, Ralph Tölg, Dietmar Trenk, Heribert Schunkert, Karl-Ludwig Laugwitz, Adnan Kastrati, Lorenz Bott-Flügel, Franz-Josef Neumann, Maurizio Menichelli, Katharina Mayer, Isabell Bernlochner, Jochen Wöhrle, Gert Richardt, Christoph Liebetrau, Bernhard Witzenbichler, David Antoniucci, Ibrahim Akin, Stefanie Schüpke, Marcus Fischer, Ulf Landmesser, Hugo A Katus, Dirk Sibbing, Melchior Seyfarth, Marion Janisch, Duino Boncompagni, Raphaela Hilz, Wolfgang Rottbauer

Journal: The New England journal of medicine 2019;381(16):1524-1534

PMID: 31475799

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Abstract

BACKGROUND

The relative merits of ticagrelor as compared with prasugrel in patients with acute coronary syndromes for whom invasive evaluation is planned are uncertain.

METHODS

In this multicenter, randomized, open-label trial, we randomly assigned patients who presented with acute coronary syndromes and for whom invasive evaluation was planned to receive either ticagrelor or prasugrel. The primary end point was the composite of death, myocardial infarction, or stroke at 1 year. A major secondary end point (the safety end point) was bleeding.

RESULTS

A total of 4018 patients underwent randomization. A primary end-point event occurred in 184 of 2012 patients (9.3%) in the ticagrelor group and in 137 of 2006 patients (6.9%) in the prasugrel group (hazard ratio, 1.36; 95% confidence interval [CI], 1.09 to 1.70; P = 0.006). The respective incidences of the individual components of the primary end point in the ticagrelor group and the prasugrel group were as follows: death, 4.5% and 3.7%; myocardial infarction, 4.8% and 3.0%; and stroke, 1.1% and 1.0%. Definite or probable stent thrombosis occurred in 1.3% of patients assigned to ticagrelor and 1.0% of patients assigned to prasugrel, and definite stent thrombosis occurred in 1.1% and 0.6%, respectively. Major bleeding (as defined by the Bleeding Academic Research Consortium scale) was observed in 5.4% of patients in the ticagrelor group and in 4.8% of patients in the prasugrel group (hazard ratio, 1.12; 95% CI, 0.83 to 1.51; P = 0.46).

CONCLUSIONS

Among patients who presented with acute coronary syndromes with or without ST-segment elevation, the incidence of death, myocardial infarction, or stroke was significantly lower among those who received prasugrel than among those who received ticagrelor, and the incidence of major bleeding was not significantly different between the two groups. (Funded by the German Center for Cardiovascular Research and Deutsches Herzzentrum München; ISAR-REACT 5 ClinicalTrials.gov number, NCT01944800.).

Address: From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig-Maximilians-University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus-Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité-University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste-Viktoria-Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg-Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten-Herdecke, Wuppertal (M.S.) - all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) - both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.).

DOI: 10.1056/NEJMoa1908973

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MeSH Terms: Acute Coronary Syndrome, Aged, Coronary Thrombosis, Female, Hemorrhage, Humans, Incidence, Kaplan-Meier Estimate, Male, Middle Aged, Myocardial Infarction, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Prasugrel Hydrochloride, Purinergic P2Y Receptor Antagonists, Stents, Stroke, Ticagrelor