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ORLANDO -- Among younger ST-segment elevation MI (STEMI) patients who can't get primary angioplasty in time, and wind up getting fibrinolytics as the main reperfusion therapy, subsequent ticagrelor (Brilinta) use may be just as safe as clopidogrel (Plavix), a randomized trial found.

The more powerful P2Y12 inhibitor, ticagrelor was non-inferior to clopidogrel when it came to the primary safety outcome of TIMI major bleeding at 30 days (0.73% ticagrelor vs 0.69% clopidogrel, P<0.001 for non-inferiority), reported Otavio Berwanger, MD, PhD, of Brazil's Heart Hospital in São Paulo, at the American College of Cardiology annual meeting.

Berwanger and co-authors of the TREAT trial had their paper simultaneously published online in .

There was no statistical difference in other defined bleeding events either, though ticagrelor recipients had numerically more minor and total bleeds. Rates of cardiovascular death, MI, stroke, recurrent ischemia, transient ischemic attack, and other arterial thrombotic events were comparable between study arms.

"STEMI guidelines recommend that ticagrelor should only be initiated after 48 hours after fibrinolysis," the authors noted. "Based on our findings, patients with STEMI younger than 75 years who initially received clopidogrel can be safely switched to ticagrelor in the first 24 hours after fibrinolysis. Whether this strategy will result in fewer cardiovascular events in the long term remains to be determined."

The TREAT investigators randomized 3,799 patients in 10 countries who had an acute ST elevations after fibrinolytic therapy to 180 mg ticagrelor (and 90 mg twice daily thereafter for 12 months) or 300 mg clopidogrel (and 75 mg a day until year's end). The phase III trial enrolled patients as early as possible after the index event, and not more than 24 hours afterward.

Berwanger acknowledged that low observed major bleeding rates made the noninferiority margin of 1% "quite wide" and reflected the more than 11-hour delay in randomizing patients after lytic therapy, as well as the modest sample size of the trial.

"Given the worldwide burden of acute coronary syndromes and the recognized exigencies which preclude the ubiquitous availability of percutaneous coronary intervention, we believe this question needs urgent attention. We await future trials," they wrote.

This would have been studied if not for the logistics of the trial, and might have taken another 2 to 3 years to complete, Berwanger said. His group was also interested in an efficacy trial, although that would have required "another PLATO trial with 18,000 patients" on their limited funding.

The 12-month analysis of TREAT is in the works, however.