Real-world evidence from a large German healthcare study suggests prasugrel is more effective than ticagrelor in reducing adverse events in patients with acute coronary syndrome undergoing invasive treatment, with particular benefits observed in certain patient subgroups.
As part of the DigiMed Bavaria Consortium, researchers investigated the comparative efficacy and safety of these two antiplatelet medications using data from the German statutory health insurance claims database. The study, published in JAMA Network Open, analyzed 17,642 matched patients between January 2012 and December 2021, successfully validating 11 of 12 predefined agreement metrics with the ISAR-REACT5 randomized clinical trial.
The investigation employed a new-user cohort design, with patients receiving either ticagrelor or prasugrel following hospital discharge after acute coronary syndrome (ACS). Using a 1:1 propensity score nearest-neighbor matching approach to balance baseline characteristics, researchers found that the primary composite endpoint of all-cause mortality, myocardial infarction (MI), or stroke within one year occurred in 815 patients (9.2%) in the ticagrelor group, compared to 663 (7.5%) in the prasugrel group (hazard ratio [HR], 1.24; 95% confidence interval [CI], 1.12-1.37).
Secondary endpoints demonstrated prasugrel's superior efficacy, with fewer instances of MI (693 [7.9%] vs 573 [6.5%]; HR, 1.20; 95% CI, 1.06-1.36) and stroke (259 [2.9%] vs 199 [2.3%]; HR, 1.33; 95% CI, 1.02-1.74). Importantly, there were no significant differences in major bleeding (HR, 1.12; 95% CI, 0.96-1.32) or stent thrombosis (HR, 1.11; 95% CI, 0.89-1.30) between the groups.
The study revealed particularly striking benefits in patients with ST-segment elevation MI (STEMI). In this subgroup, the primary endpoint occurred in 338 of 4,941 patients (6.8%) in the prasugrel group compared to 451 of 4,852 patients (9.3%) in the ticagrelor group (HR, 1.38; 95% CI, 1.20-1.59). No significant differences were found in patients with non-ST elevation MI or unstable angina.
The researchers noted several study limitations. Unlike the ISAR-REACT5 trial, which randomized patients before invasive treatment, this study used the first outpatient initiation of medication as the starting point, excluding in-hospital data. While the study couldn't fully examine aspirin's role due to limitations in capturing over-the-counter drug use, prescription fills were comparable between groups (53.9% for ticagrelor vs 54.9% for prasugrel). Additionally, treatment choice was left to physician discretion, introducing potential selection bias.
Despite these limitations, the findings provide robust real-world evidence supporting the European Society of Cardiology's 2023 guideline recommendation favoring prasugrel over ticagrelor for patients with ACS who proceed to percutaneous coronary intervention. The study's close alignment with the ISAR-REACT5 trial results strengthens the evidence base for this treatment approach in routine clinical practice.
The study included a diverse patient population with a mean age of 63.1 years, of whom 73.9% were male. While conducted using German health claims data, the population closely mirrored the Central-Western European population studied in ISAR-REACT5, suggesting broader applicability of the findings.
Full disclosures and detailed methodology can be found in the published study.
