[PEGASUS - Ticagrelor in secondary prevention on patients after a myocardial infarction]

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.

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.

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.

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.