[PEGASUS - Ticagrelor in secondary prevention on patients after a myocardial infarction]. / Pegasus - Tikagrelor v sekundární prevenci u nemocných po infarktu myokardu.

ABSTRACT

BACKGROUND: Ticagrelor is a P2Y12 receptor antagonist that has been shown to reduce ischemic events for up to a year after an acute coronary syndrome. The efficacy and safety of long-term ticagrelor therapy beyond 1 year after a myocardial infarction is unknown. METHODS: We randomized 21,162 patients with a history of myocardial infarction within the prior 1-3 years in a double-blind 1 1 1 fashion to ticagrelor 90 mg twice daily, ticagrelor 60 mg twice daily, or placebo, all with low-dose aspirin, and followed them for a median of 33 months. The primary efficacy endpoint was the composite of cardiovascular death, myocardial infarction, or stroke. The primary safety endpoint was TIMI major bleeding. RESULTS: Both doses of ticagrelor significantly reduced the primary combined efficacy endpoint compared to placebo with Kaplan-Meier rates at 3 years of 7.85 % with ticagrelor 90 mg, 7.77 % with ticagrelor 60 mg, and 9.04 % with placebo (HR for ticagrelor 90 mg vs placebo 0.85, 95% CI 0.75-0.96, p = 0.0080; HR for ticagrelor 60 mg vs placebo 0.84, 95% CI 0.74-0.95, p = 0.0043). Rates of TIMI major bleeding were higher with ticagrelor (2.60 % for 90 mg, 2.30 % for 60 mg and 1.06 % for placebo, p < 0.001 for each dose against placebo); the rates of intracranial hemorrhage or fatal bleeding were 0.63 %, 0.71 % and 0.60 % in the 3 arms, respectively. CONCLUSIONS: Treatment of patients more than 1 year after a myocardial infarction with ticagrelor reduces the risk of cardi-ovascular death, myocardial infarction, or stroke, and increases the risk of major bleeding.Key words myocardial infarction - secondary prevention - ticagrelor.