EUCLID Evaluates Ticagrelor in Symptomatic PAD
January 5, 2017—Findings from the EUCLID trial comparing the cardiovascular effects of ticagrelor (Brilinta, AstraZeneca) versus clopidogrel in patients with symptomatic peripheral artery disease (PAD) were published by William R. Hiatt, MD, et al in The New England Journal of Medicine (NEJM; 2017;376:32–40).
The trial, which was sponsored by AstraZeneca, found that in patients with symptomatic PAD, ticagrelor was not shown to be superior to clopidogrel for the reduction of cardiovascular events and that major bleeding occurred at similar rates among the patients in the two trial groups.
As summarized in NEJM, the investigators in this double-blind, event-driven trial randomly assigned 13,885 patients with symptomatic PAD to receive monotherapy with ticagrelor (90 mg twice daily) or clopidogrel (75 mg once daily). Patients were eligible if they had an ankle-brachial index (ABI) ≤ 0.8 or had undergone previous revascularization of the lower limbs. The primary efficacy endpoint was a composite of adjudicated cardiovascular death, myocardial infarction, or ischemic stroke. The primary safety endpoint was major bleeding, and the median follow-up was 30 months.
In the study, the median age of the patients was 66 years, and 72% were men; 43% were enrolled on the basis of the ABI and 57% on the basis of previous revascularization. The mean baseline ABI in all patients was 0.71, 76.6% of the patients had claudication, and 4.6% had critical limb ischemia.
The primary efficacy endpoint occurred in 751 of 6,930 patients (10.8%) receiving ticagrelor and in 740 of 6,955 patients (10.6%) receiving clopidogrel (hazard ratio [HR], 1.02; 95% confidence interval [CI], 0.92–1.13; P = .65). In each group, acute limb ischemia occurred in 1.7% of the patients (HR, 1.03; 95% CI, 0.79–1.33; P = .85) and major bleeding in 1.6% (HR, 1.1; 95% CI, 0.84–1.43; P = .49), reported the EUCLID investigators in NEJM.