March 18, 2019 – When comparing ischemic endpoints, no significant difference was found between patients who received ticagrelor and patients who received clopidogrel.
According to results presented as a late-breaking clinical trial in New Orleans at the 2019 American College of Cardiology’s Scientific Sessions and published in the Journal of the American College of Cardiology, ticagrelor is as safe as clopidogrel when administered to patients with ST-elevation myocardial infarction (STEMI) who were treated with thrombolysis.
The TicagRElor in pAtients with ST-elevation myocardial infarction treated with pharmacological Thrombolysis (TREAT) trial was led by Otavio Berwanger, MD, PhD, chair of the TREAT Trial Steering Committee. Previous literature had shown that ticagrelor is superior to clopidogrel in both patients with STEMI and non-ST-elevation myocardial infarction, but patients who were treated with thrombolysis were excluded from previous trials. Because thrombolysis is associated with greater bleeding risk, there had been concern about using the more potent option, said the DCRI’s Renato D. Lopes, MD, MHS, PhD, who served on the steering committee and as the clinical events classification (CEC) chair for the trial.
TREAT enrolled 3,799 patients younger than 75 in 10 countries and randomized participants to one of two treatment arms: ticagrelor or clopidogrel. The initial results, which were published in JAMA Cardiology last year, showed no significant difference in major bleeding between the treatment groups after 30 days.
The 12-month results presented at the ACC again examined bleeding, as well as ischemic endpoints, such as death, recurring myocardial infarction (MI), stroke, and vascular death. Again, there was no significant difference between the two groups:
- Composite outcome of death from vascular causes, MI, or stroke: 6.7 percent of patients who received ticagrelor versus 7.3 percent of patients who received clopidogrel;
- Composite outcome of death from vascular causes, MI, stroke, severe recurrent ischemia, transient ischemic attack, or other arterial thrombotic events: 8.0 percent of ticagrelor patients, as compared to 9.1 percent of patients on clopidogrel.
These results confirm, 12 months after treatment, ticagrelor’s safety as compared to clopidogrel in patients who received thrombolysis.
“Investigators and clinicians can be encouraged by these results, which extend ticagrelor’s safety in patients who received thrombolysis from 30 days to 12 months,” Berwanger said. “We can now be confident in using a more antiplatelet agent without compromising the safety of our patients.”
This trial represents the largest trial of ticagrelor in STEMI patients treated with thrombolysis. This was an investigator-initiated trial funded by AstraZeneca.