PEGASUS–TIMI 54: Ticagrelor linked with better outcomes in patients at least 1 year after MI
SAN DIEGO — Treatment with ticagrelor reduced the risk for CV death, MI or stroke in patients with MI within the previous 1 to 3 years, according to results from the PEGASUS-TIMI 54 study.
Those patients assigned ticagrelor (Brilinta, AstraZeneca) had an increased risk for major bleeding, according to the findings, which were presented at the American College of Cardiology Scientific Sessions here and published in The New England Journal of Medicine.
Marc S. Sabatine
Marc S. Sabatine, MD, MPH, from the TIMI Study Group, division of cardiovascular medicine, Brigham and Women's Hospital and Harvard Medical School, and colleagues investigated whether there is a benefit to dual antiplatelet therapy with ticagrelor and aspirin beyond 1 year after MI.
The researchers enrolled 21,162 patients who had a MI within the previous 1 to 3 years in the PEGASUS-TIMI 54 study.
All patients received low-dose aspirin. They were randomized on a 1:1:1 basis to receive twice-daily doses of ticagrelor 90 mg, ticagrelor 60 mg or placebo.
The primary efficacy endpoint was a composite of CV death, MI or stroke. The primary safety endpoint was TIMI major bleeding. Median follow-up was 33 months.
At 3 years, the Kaplan-Meier rates of the primary efficacy endpoint were 7.85% in the ticagrelor 90-mg group, 7.77% in the ticagrelor 60-mg group, and 9.04% in the placebo group, according to the researchers.
Compared with those assigned placebo, those assigned ticagrelor 90 mg (HR = 0.85; 95% CI, 0.75-0.96) and those assigned ticagrelor 60 mg (HR = 0.84; 95% CI, 0.74-0.95) had a lower risk for the primary efficacy outcome, Sabatine said in a press conference.
"With the addition of this antiplatelet drug, the curves start to diverge early, and they continue to separate out over time, further supporting the notion of long-term dual antiplatelet therapy with aspirin and ticagrelor in these individuals," he said. "The benefit of ticagrelor was consistent for both the fatal and nonfatal components of the primary endpoint. It was consistent over the duration of treatment and amongst the major clinical subgroups."
The researchers found that rates of TIMI major bleeding were higher in those assigned ticagrelor (90-mg group, 2.6%; placebo group, 1.06%; P < .001; 60-mg group, 2.3%; placebo group, 1.06%; P < .001).
However, the rates of intracranial hemorrhage or fatal bleeding were 0.63% in the ticagrelor 90-mg group, 0.71% in the ticagrelor 60-mg group and 0.6% in the placebo group, they found.
"Importantly, there was no difference in the so-called irreversible bleeding events," Sabatine said. - by Erik Swain
Sabatine MS, et al. ACC.15 Opening Showcase and the Joint ACC/JACC Late-Breaking Clinical Trials. Presented at: American College of Cardiology Scientific Sessions; March 14-16, 2015; San Diego.
Disclosure: The study was funded by AstraZeneca. Sabatine reports financial ties with Abbott Laboratories, Accumetrix, Aegerion, Amgen, AstraZeneca, Bristol-Myers Squibb, Critical Diagnostics, Cubist, CVS Caremark, Daiichi Sankyo, Eisai, Genzyme, Gilead, GlaxoSmithKline, Intarcia, Merck, MyoKardia, Nanosphere, Pfizer, Quest Diagnostics, Roche Diagnostics, Sanofi-Aventis, Takeda, Vertex and Zeus Scientific. He also reports two pending patents related to the results of the study.