Age- And weight-adapted dose of prasugrel versus standard dose of ticagrelor in patients with acute coronary syndromes: Results from a randomized trial

Menichelli M, Neumann FJ, Ndrepepa G, Mayer K, Woehrle J, Bernlochner I, Richardt G, Witzenbichler B, Sibbing D, Gewalt S, Angiolillo DJ, Lahu S, Hamm CW, Hapfelmeier A, Trenk D, Laugwitz KL, Schunkert H, Schuepke S, Kastrati A (2020)

Publication Type: Journal article

Publication year: 2020

Journal

Annals of Internal Medicine American College of Physicians

Book Volume: 173

Pages Range: 436-444

Journal Issue: 6

DOI: 10.7326/M20-1806

Abstract

Background: The efficacy and safety of a reduced dose of prasugrel versus a standard dose of ticagrelor in elderly patients or those with a low body weight presenting with an acute coronary syndrome (ACS) are unknown. Objective: To investigate the effect of an age- and weight-adapted dose of prasugrel versus a standard dose of ticagrelor in patients with ACS. (ClinicalTrials.gov: NCT01944800) Design: Prespecified analysis of the multicenter, randomized ISAR-REACT 5 trial. Setting: 23 centers in Germany and Italy. Patients: 3997 patients with ACS planned for invasive management. Intervention: Participants were randomly assigned to receive a standard dose of ticagrelor or prasugrel (reduced dose in the elderly or low-weight group and standard dose in the neither elderly nor low-weight group). Measurements: The efficacy end point was a composite of death, myocardial infarction, or stroke, and the safety end point was bleeding, both at 12 months. Results: In the elderly or low-weight group, the efficacy end point occurred in 12.7% of patients assigned to receive prasugrel and 14.6% of those assigned to receive ticagrelor (hazard ratio [HR], 0.82 [95% CI, 0.60 to 1.14]); in the neither elderly nor low-weight group, the efficacy end point occurred in 4.8% of patients assigned to receive prasugrel and 7.3% of those assigned to receive ticagrelor (HR, 0.65 [CI, 0.48 to 0.88]; P for interaction > 0.2). In the elderly or low-weight group, Bleeding Academic Research Consortium type 3 to 5 bleeding occurred in 8.1% of patients assigned to receive prasugrel and 10.6% of those assigned to receive ticagrelor (HR, 0.72 [0.46 to 1.12]), and in 3.7% and 3.8%, respectively, of patients in the neither elderly nor low-weight group (HR, 0.98 [CI, 0.65 to 1.47]; P for interaction > 0.2). Limitation: The study is a subgroup analysis. Conclusion: In elderly or low-weight patients with ACS, a reduced dose of prasugrel compared with the standard dose of ticagrelor is associated with maintained anti-ischemic efficacy while protecting these patients against the excess risk for bleeding. Primary Funding Source: German Center for Cardiovascular Research and Deutsches Herzzentrum München.

Involved external institutions

Deutsches Herzzentrum München DE Germany (DE) Klinikum rechts der Isar DE Germany (DE) HELIOS Kliniken DE Germany (DE) Justus-Liebig-Universität Gießen DE Germany (DE) Technische Universität München (TUM) DE Germany (DE) Ospedale Fabrizio Spaziani IT Italy (IT) Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH DE Germany (DE) Medizin Campus Bodensee DE Germany (DE) Segeberger Kliniken DE Germany (DE) Ludwig-Maximilians-Universität (LMU) DE Germany (DE) University of Florida US United States (USA) (US)

How to cite

APA:

Menichelli, M., Neumann, F.-J., Ndrepepa, G., Mayer, K., Woehrle, J., Bernlochner, I.,... Kastrati, A. (2020). Age- And weight-adapted dose of prasugrel versus standard dose of ticagrelor in patients with acute coronary syndromes: Results from a randomized trial. Annals of Internal Medicine, 173(6), 436-444. https://doi.org/10.7326/M20-1806

MLA:

Menichelli, Maurizio, et al. "Age- And weight-adapted dose of prasugrel versus standard dose of ticagrelor in patients with acute coronary syndromes: Results from a randomized trial." Annals of Internal Medicine 173.6 (2020): 436-444.

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