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NEW ORLEANS—Results of the EUCLID trial suggest ticagrelor does not a provide a benefit over clopidogrel in patients with symptomatic peripheral artery disease (PAD).
The incidence of atherothrombotic events was similar in patients who received ticagrelor and those who received clopidogrel.
Likewise, there was no significant difference between the treatment arms with regard to major bleeding.
Manesh R. Patel, MD, of Duke University Medical Center in Durham, North Carolina, presented results from the EUCLID trial at the American Heart Association Scientific Sessions.
Results were also published in NEJM. The trial was supported by AstraZeneca.
EUCLID included 13,885 patients with symptomatic PAD. They had median age of 66, and 72% were male.
The patients were randomized to receive ticagrelor at 90 mg twice daily or clopidogrel at 75 mg once daily.
The study’s primary efficacy endpoint was a composite of adjudicated cardiovascular death, myocardial infarction, and ischemic stroke.
At a median follow-up of 30 months, the primary efficacy endpoint had occurred in 10.8% (751/6930) of patients in the ticagrelor arm and 10.6% (740/6955) in the clopidogrel arm (P=0.65).
When the researchers assessed each of the components of the primary endpoint alone, they found a significant difference between the treatment groups in the incidence of ischemic stroke but not cardiovascular death or myocardial infarction.
Cardiovascular death occurred in 5.2% of patients in the ticagrelor arm and 4.9% of those in the clopidogrel arm (P=0.40). Myocardial infarction occurred in 5% and 4.8%, respectively (P=0.48). And ischemic stroke occurred in 1.9% and 2.4%, respectively (P=0.03).
The study’s primary safety endpoint was major bleeding, which occurred in 1.6% of patients in both treatment arms (P=0.49).
Fatal bleeding occurred in 0.1% of patients in the ticagrelor arm and 0.3% of patients in the clopidogrel arm (P=0.10). And intracranial bleeding occurred in 0.5% of patients in both arms (P=0.82).
However, significantly more patients discontinued ticagrelor due to bleeding—2.4%, compared to 1.6% of patients who discontinued clopidogrel due to bleeding (P<0.001).
Significantly more patients discontinued ticagrelor due to dyspnea as well—4.8% vs 0.8% (P<0.001).
In all, 30.1% of patients in the ticagrelor arm and 25.9% of those in the clopidogrel arm prematurely discontinued treatment. This includes patients who discontinued due to adverse events, meeting the primary efficacy endpoint, and death.
