1. Age- and Weight-Adapted Dose of Prasugrel Versus Standard Dose of Ticagrelor in Patients With Acute Coronary Syndromes : Results From a Randomized Trial.
- Author
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Menichelli, Maurizio, Neumann, Franz-Josef, Ndrepepa, Gjin, Mayer, Katharina, Wöhrle, Jochen, Bernlochner, Isabell, Richardt, Gert, Witzenbichler, Bernhard, Sibbing, Dirk, Gewalt, Senta, Angiolillo, Dominick J., Lahu, Shqipdona, Hamm, Christian W., Hapfelmeier, Alexander, Trenk, Dietmar, Laugwitz, Karl-Ludwig, Schunkert, Heribert, Schüpke, Stefanie, and Kastrati, Adnan
- Subjects
ACUTE coronary syndrome ,OLDER patients ,PRASUGREL ,PERCUTANEOUS coronary intervention ,MYOCARDIAL infarction ,RESEARCH ,BODY weight ,AGE distribution ,RESEARCH methodology ,EVALUATION research ,MEDICAL cooperation ,TREATMENT effectiveness ,COMPARATIVE studies ,RANDOMIZED controlled trials ,PLATELET aggregation inhibitors ,GENETIC techniques ,STATISTICAL sampling ,DOSAGE forms of drugs ,HEMORRHAGE - 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. [ABSTRACT FROM AUTHOR]- Published
- 2020
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