Key result
Ticagrelor 60 mg reduces major cardiovascular events ~20% vs placebo in post-MI patients.
Why the study?
To evaluate the efficacy and safety of ticagrelor 60 mg b.i.d. in the subpopulation of PEGASUS-TIMI 54 recommended for treatment in the European label.
Does long-term ticagrelor 60 mg twice daily reduce major adverse cardiovascular events in stable high-risk patients when initiated within 2 years of a prior MI or within 1 year of stopping previous ADP receptor inhibitor therapy?
RCT (n=10,779)
Double-blind
randomized
Yes
Does long-term ticagrelor 60 mg twice daily reduce major adverse cardiovascular events in stable high-risk patients when initiated within 2 years of a prior MI or within 1 year of stopping previous ADP receptor inhibitor therapy?
In high-risk post-MI patients meeting EU label criteria, long-term continuation of ticagrelor 60 mg twice daily safely and significantly reduces cardiovascular death, MI, and stroke by 20% compared to placebo, without increasing fatal or intracranial bleeding.
Answers are grounded in this paper and cite their sources.
Supports extended ticagrelor 60 mg twice daily post-MI; confirms benefit in the EU label subpopulation.
AIMS: In 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 RESULTS: Of 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). CONCLUSION: In 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.
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Dellborg et al. (2019) conducted an RCT in Prior myocardial infarction (n=10,779). Ticagrelor vs. Matching placebo was evaluated on Composite of cardiovascular death, myocardial infarction, or stroke (HR 0.80, 95% CI 0.70-0.91, p=0.001). Ticagrelor 60 mg twice daily reduced the risk of cardiovascular death, myocardial infarction, or stroke by 20% (HR 0.80, 95% CI 0.70-0.91; P=0.001) compared to placebo in the EU label subpopulation.
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