A randomized clinical trial of patients with ST-segment elevation myocardial infarction (STEMI) found no significant difference in major bleeding for adult patients administered ticagrelor compared to clopidogrel following fibrinolytic therapy.
The results come from the TREAT study involving 3,799 patients that was presented at the ACC.18 Scientific Sessions & Expo. All enrollees were under 75 years of age and were randomized after a median of 11.4 hours after fibrinolysis to either ticagrelor (180mg loading dose + 90mg twice daily) or clopidogrel (300mg to 600mg loading dose + 75mg daily thereafter). Most patients (90%) were pretreated with clopidogrel. The upper boundary outcome for noninferiority was an absolute margin of 1.0%.
The primary outcome was thrombolysis in myocardial infarction (TIMI) major bleeding through 30 days. The analysis found that TIMI major bleeding had occurred in 14 of the 1,913 (0.73%) receiving ticagrelor and in 13 of 1,886 (0.69%) receiving clopidogrel (absolute difference, 0.04%; 95% CI: −0.49% to 0.58%; P<0.001 for noninferiority).
Minor bleeding was more common in the ticagrelor group vs the clopidogrel group, and while noninferiority was shown, the researchers noted that there was no benefit on efficacy outcomes for ticagrelor vs clopidogrel. The rates of intracranial bleeding between ticagrelor and clopidogrel were similar at 0.42% vs 0.37% (P=0.82), respectively. The rates of fatal bleeding were also similar between the ticagrelor and clopidogrel arms (0.16% vs 0.11%; P=0.67).
In addition, no difference between the study groups in terms of rates of major bleeding according to BARC (Bleeding Academic Research Consortium) and PLATO (Study of Platelet Inhibition and Platelet Outcomes) criteria were observed.
“Because most of the included patients were pretreated with clopidogrel, these findings reflect mostly the noninferiority of switching from clopidogrel to ticagrelor in patients already treated with clopidogrel,” noted lead author, Otavio Berwanger, MD, PhD, Research Institute, Heart Hospital, São Paulo, Brazil.
Berwanger O, et al. A Phase III, Randomized, International, Multicenter, Open label, with Blinded Adjudication of Outcomes, Non-Inferiority Clinical Trial to Explore the Safety and Efficacy of Ticagrelor Compared with Clopidogrel in Patients with Acute Coronary Syndrome with ST Elevation Treated with Thrombolysis. Presented at: ACC.18 Scientific Sessions & Expo. March 10–12, 2018; Orlando, FL. Abstract 404-12.