Abstract
AimsIn PEGASUS-TIMI 54, ticagrelor significantly reduced the risk of the composite of major adverse cardiovascular (CV) events by 15–16% in stable patients with a prior myocardial infarction (MI) 1–3 years earlier. We report the efficacy and safety in the subpopulation recommended for treatment in the European (EU) label, i.e. treatment with 60 mg b.i.d. initiated up to 2 years from the MI, or within 1 year after stopping previous adenosine diphosphate receptor inhibitor treatment.Methods and resultsOf the 21 162 patients enrolled in PEGASUS-TIMI 54, 10 779 patients were included in the primary analysis for this study, randomized to ticagrelor 60 mg (n = 5388) or matching placebo (n = 5391). The cumulative proportions of patients with events at 36 months were calculated by the Kaplan–Meier (KM) method. The composite of CV death, MI, or stroke occurred less frequently in the ticagrelor group (7.9% KM rate vs. 9.6%), hazard ratio (HR) 0.80 [95% confidence interval (CI) 0.70–0.91; P = 0.001]. Ticagrelor also reduced the risk of all-cause mortality, HR 0.80 (0.67–0.96; P = 0.018). Thrombolysis in myocardial infarction major bleeding was more frequent in the ticagrelor group 2.5% vs. 1.1%; HR 2.36 (1.65–3.39; P < 0.001). The corresponding HR for fatal or intracranial bleeding was 1.17 (0.68–2.01; P = 0.58).ConclusionIn PEGASUS-TIMI 54, treatment with ticagrelor 60 mg as recommended in the EU label, was associated with a relative risk reduction of 20% in CV death, MI, or stroke. Thrombolysis in myocardial infarction major bleeding was increased, but fatal or intracranial bleeding was similar to placebo. There appears to be a favourable benefit-risk ratio for long-term ticagrelor 60 mg in this population.Clinical trial registration http://www.clinicaltrials.gov NCT01225562
Highlights
60 mg and 5391 in the placebo group (EU label group)
The composite of CV death, myocardial infarction (MI), or stroke occurred less frequently in the ticagrelor group (7.9% KM rate vs. 9.6%), hazard ratio (HR) 0.80 [95% confidence interval (CI) 0.70–0.91; P = 0.001]
Thrombolysis in myocardial infarction major bleeding was more frequent in the ticagrelor group 2.5% vs. 1.1%; HR 2.36 (1.65–3.39; P < 0.001)
Summary
60 mg and 5391 in the placebo group (EU label group). Patients randomized to ticagrelor 60 mg or placebo who did not qualify perIn acute coronary syndrome with or without ST-segment elevation, the EU label are termed the non-EU label group. 60 mg and 5391 in the placebo group (EU label group). Patients randomized to ticagrelor 60 mg or placebo who did not qualify per. In acute coronary syndrome with or without ST-segment elevation, the EU label are termed the non-EU label group. European guidelines recommend dual antiplatelet treatment for at randomized to ticagrelor 90 mg who would have qualified for the EU least the first year.. Many stable patients with a history of label (n = 5374) are presented in the Supplementary material myocardial infarction (MI) remain at high risk after this period.. In online for the sake of completeness. PEGASUS-TIMI 54, ticagrelor, at doses of either 90 mg b.i.d. or 60 mg Endpoints b.i.d., significantly reduced the risk of the composite of major adverse
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More From: European heart journal. Cardiovascular pharmacotherapy
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