Abstract 4588: Regional Safety and Efficacy of Prasugrel Compared to Clopidogrel: A TRITON - TIMI 38 Analysis
Background: Among patients with acute coronary syndrome (ACS), demographics, procedural characteristics and adjunctive therapies differ throughout the world. We examined whether there were consistent effects of prasugrel compared to clopidogrel in the multinational TRITON - TIMI 38 study.
Methods: We divided the enrollment into 5 pre-specified geographic regions: North America (NA), South America (SA), Western Europe (WE), Eastern Europe (EE), and Africa/Asia Pacific/Middle East (AAM). Patients were randomized to prasugrel or clopidogrel without regard to country of enrollment for 6 –15 months. Event rates are expressed as Kaplan-Meier failure estimates through 15 months. Heterogeneity was evaluated using Cox proportional hazards model with NA serving as the referent.
Results: 13,608 patients were enrolled; 32% in NA, 26% in WE, 24% in EE, 14% in AAM, 4% in SA. Clinical characteristics including age, comorbidities, ACS presentation, stent types, and adjunctive medications differed broadly among regions. Despite these differences, consistency of the efficacy improvement and bleeding excess of prasugrel were observed (TABLE⇓). Stent thrombosis was substantially reduced with prasugrel in each region: NA (HR 0.42, P<0.001), SA (HR 0.49, P=0.23), WE (HR 0.72, P=0.23), EE (HR 0.41, P=0.005), AAM (HR 0.34, P=0.005), P interaction = NS for each. Net Clinical Benefit (Death/MI/Stroke/non-CABG Major Bleed) also showed consistency (P interaction = NS for each).
Conclusions: Despite differences in patient demographics, procedural techniques and adjunctive medications, consistent effects of reduction of ischemic events and increased bleeding were seen with prasugrel compared to clopidogrel throughout the world.