Prasugrel versus Ticagrelor in Patients with Acute Myocardial Infarction Treated with Primary Percutaneous Coronary Intervention: Multicenter Randomized PRAGUE-18 Study
BACKGROUND: No randomized "head-to-head" comparison of the efficacy and safety of ticagrelor vs. prasugrel has been published in the seven years since the higher efficacy of these newer P2Y12 inhibitors were first demonstrated relative to clopidogrel.
METHODS: This academic study was designed to compare the efficacy and safety of prasugrel and ticagrelor in acute myocardial infarction (AMI) treated with primary or immediate percutaneous coronary intervention (PCI). A total of 1230 patients were randomly assigned, across 14 sites, to either prasugrel or ticagrelor, which was initiated before PCI. Nearly 4% were in cardiogenic shock and 5.2% were on mechanical ventilation. Primary end-point was defined as death, re-infarction, urgent target vessel revascularization, stroke, serious bleeding requiring transfusion or prolonging hospitalization at 7 days (to reflect primarily the in-hospital phase). This analysis presents data from the first 30 days (key secondary end-point). The total follow-up will be 1 year for all patients and will be completed in 2017.
RESULTS: The study was prematurely terminated for futility. The occurrence of the primary endpoint did not differ between groups receiving prasugrel and ticagrelor (4.0% and 4.1%, respectively; OR (95% CI) 0.98 (0.55; 1.73); P=0.939). No significant difference was found in any of the components of the primary endpoint. The occurrence of key secondary end-point within 30 days, composed of cardiovascular death, non-fatal MI, or stroke did not show any significant difference between prasugrel and ticagrelor (2.7% and 2.5%, respectively; OR (95% CI) 1.06 (0.53; 2.15); P=0.864).
Conclusion: This head-to-head comparison of prasugrel and ticagrelor does not support the hypothesis that one is more effective or safer than the other in preventing ischemic and bleeding events in the acute phase of myocardial infarction treated with primary PCI strategy. The observed rates of major outcomes were similar, although with broad confidence intervals around the estimates. These interesting observations need to be confirmed in a larger trial.
Clinical Trial Registration: URL: http://www.ClinicalTrials.gov. Unique identifier: NCT02808767.
- Received August 2, 2016.
- Revision received August 12, 2016.
- Accepted August 19, 2016.