There has been a lot of speculation and indecisiveness regarding bleeding safety of ticagrelor in patients with ST-elevation myocardial infarction treated with fibrinolytic therapy.The present STEMI guidelines recommend that ticagrelor should only be initiated after 48 hours after fibrinolysis. The Writing Committee of (TREAT)Study Group conducted a Randomized Clinical Trial to evaluate the short-term safety of ticagrelor when compared with clopidogrel in patients with ST-elevation myocardial infarction treated with fibrinolytic therapy.The researchers found that delayed administration of ticagrelor was noninferior to clopidogrel in terms of major bleeding risk at 30 days in patients younger than 75 years with an ST-segment elevation myocardial infarction (STEMI).It implied that bleeding was similar upon delayed administration of ticagrelor versus clopidogrel.The results of Trial have been published in JAMA Cardiology.
A multicenter, randomized, open-label trial was conducted with blinded endpoint adjudication enrolling 3799 patients (younger than 75 years) with ST-segment elevation myocardial infarction receiving fibrinolytic therapy in 152 sites conducted from 10 countries from November 2015 through November 2017.The mean age was 58.0 and 77.1% of participants were men.The patients were randomized to ticagrelor (180-mg loading dose, 90 mg twice daily thereafter) or clopidogrel (300-mg to 600-mg loading dose, 75 mg daily thereafter). 90% of patients randomized were with a median of 11.4 hours after fibrinolysis and were pretreated with clopidogrel.The prespecified upper boundary for noninferiority for bleeding was an absolute margin of 1.0% and the primary outcome was thrombolysis in myocardial infarction (TIMI) major bleeding through 30 days.
It was found that the rates of fatal and intracranial bleeding were similar between the ticagrelor and clopidogrel groups, respectively. Minor and minimal bleeding were more common with ticagrelor than with clopidogrel. The composite of death from vascular causes, myocardial infarction, or stroke occurred in 76 patients (4.0%) treated with ticagrelor and in 82 patients (4.3%) receiving clopidogrel.
It was therefore concluded that in patients younger than 75 years with ST-segment elevation myocardial infarction, delayed administration of ticagrelor after fibrinolytic therapy was noninferior to clopidogrel for TIMI major bleeding at 30 days.