PEGASUS-TIMI 54: 60 mg of Ticagrelor Reduced Stroke Risk in High-Risk MI Patients
The addition of ticagrelor (60 mg/twice daily) significantly reduced the risk of stroke in high-risk patients with prior myocardial infarction (MI), according to results of the PEGASUS-TIMI 54 Trial presented Aug. 30 during ESC Congress 2016 in Rome and simultaneously published in Circulation.
The study randomly assigned 14,112 to placebo or ticagrelor (60 mg/twice daily). Patients were followed for 33 months with investigators assessing the incidence of stroke, outcomes after stroke and efficacy of ticagrelor for reducing stroke. Stroke events were adjudicated by a central committee. Data from similar trials were combined using meta-analysis.
Of the more than 14,000 patients, 213 experienced a stroke, of which 85 percent were ischemic. A total of 18 percent of strokes were fatal and another 15 percent led to either moderate or severe disability at 30 days. Investigators note stroke risk was significantly reduced in the ticagrelor group (hazard ratio [HR], 0.75; 95 percent confidence interval [CI], 0.57–0.98; P=0.034), driven by a reduction in ischemic stroke (HR, 0.76; 95 percent CI, 0.56–1.02). Hemorrhagic stroke occurred in nine patients in the placebo group and eight patients in the ticagrelor group. Additionally, a meta-analysis across four placebo-controlled trials of more intensive antiplatelet therapy in 44,816 patients with coronary disease confirmed a marked reduction in ischemic stroke (HR, 0.66; 95 percent CI, 0.54–0.81; P=0.0001).
Researchers did note that ticagrelor did increase TIMI major bleeding (HR, 2.32; 95 percent CI, 1.68–3.21; P<0.001), but with no statistically significant increase in intracranial hemorrhage (HR, 1.33; 95 percent CI, 0.77–2.31; P=0.31) or fatal bleeding (HR, 1.00; 95 percent CI, 0.44–2.27; P=1.00).
“Considering absolute risk, for 1,000 patients initiated on ticagrelor (60 mg/twice daily for three years), 13 primary end-point events would be prevented including approximately five ischemic strokes,” they said. “This benefit would come at a cost of nine TIMI major bleeds but no hemorrhagic strokes or fatal bleeds.”
Moving forward, they suggest that “in high-risk patients with coronary disease, more intensive antiplatelet therapy should be considered not only to reduce the risk of coronary events, but also of stroke.”
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