One-year Outcomes of Prasugrel Versus Ticagrelor In Acute Myocardial Infarction Treated With Primary Angioplasty: The PRAGUE-18 Study

Abstract Background Early outcomes of patients in the PRAGUE-18 study did not find any significant differences between two potent P2Y 12 inhibitors. Objective The one-year follow-up of the PRAGUE-18 study focused on (1) a comparison of efficacy and safety between prasugrel and ticagrelor, and (2) on the risk of major ischemic events related to an economically motivated post-discharge switch to clopidogrel. Methods A total of 1,230 patients with acute myocardial infarction (MI) treated with primary PCI were randomized to prasugrel or ticagrelor with an intended treatment duration of 12 months. The combined endpoint was cardiovascular death, MI, or stroke at one year. Since patients had to cover the costs of study medication after hospital discharge, some patients decided to switch to clopidogrel. Results The endpoint occurred in 6.6% of prasugrel patients and in 5.7% of ticagrelor patients; HR, 1.167; 95% CI, 0.742–1.835; P=0.503. No significant differences were found in: cardiovascular death (3.3% vs. 3.0%, P=0.769), MI (3.0% vs. 2.5%, P=0.611), stroke (1.1% vs. 0.7%, P=0.423), all-cause death (4.7% vs. 4.2%, P=0.654), definite stent thrombosis (1.1% vs. 1.5%, P=0.535), all bleeding (10.9% vs. 11.1%, P=0.999), and TIMI major bleeding (0.9% vs. 0.7%, P=0.754). The percentage of patients who switched to clopidogrel for economic reasons was 34.1% (N=216) for prasugrel and 44.4% (N=265) for ticagrelor, P=0.003. Patients who were economically motivated to switched to clopidogrel had (compared to patients who continued the study medications) a lower risk of major cardiovascular events, however they also had lower ischemic risk. Conclusion Prasugrel and ticagrelor are similarly effective during the first year after MI. Economically motivated early post-discharge switches to clopidogrel were not associated with an increased risk of ischemic events. Clinicaltrials.gov NCT02808767