Over the long term, therapy that combined ticagrelor and aspirin appeared to maintain a lower rate of recurrent MI, cardiovascular death or stroke in patients with prior MI. Rates of major bleeding, however, were higher with the P2Y12 receptor inhibitor over the three-year follow up.
Senior researcher for the PEGASUS-TIMI 54 trial, Marc S. Sabatine, MD, MPH, of Brigham and Women’s Hospital in Boston, presented the long-term findings March 14 at the American College of Cardiology scientific session in San Diego. Patients enrolled in the study had experienced a heart attack within a one- to three-year window and were at risk for a second.
The PEGASUS-TIMI 54 (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54) trial enrolled 21,162 patients. In a double-blind assignment; patients were randomized with aspirin to either ticagrelor (Brilinta, AstraZeneca) at 90 mg twice daily, 60 mg twice daily or a placebo.
They found that rates of death, repeat heart attack or stroke were significantly reduced on ticagrelor: 7.85 percent for patients given the 90 mg dose, 7.77 percent for patients given the 60 mg dose and 9.04 percent for patients taking the placebo. Major bleeding risks, however, were increased; patients on either the 90 or 60 mg dose had more than double the bleeding risk of placebo (hazard ratio 2.69 and 2.32, respectively).
In the press conference, Sabatine said that although P2Y12 inhibitors are generally only prescribed for a limited time, there were "clues that prolonging therapy might be better."
"The curves diverged early and stayed separated," Sabatine noted.“The benefit we saw was remarkably consistent across the individual components of the endpoint and in all the major subgroups of patients. Moreover, we followed patients for an average of just under three years, and our event curves continue to spread out over time, suggesting that the benefit continues to accrue over time,” Sabatine said in a press release.
This study was concurrently published online March 14 in the New England Journal of Medicine.