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Efficacy and safety with ticagrelor in patients with prior myocardial infarction in the approved European label: insights from PEGASUS-TIMI 54

  • Dellborg, Mikael
  • Bonaca, Marc
  • Storey, Robert
  • Steg, P Gabriel
  • Im, Kyung
  • Cohen, Marc
  • Bhatt, Deepak
  • Oude Ophuis, Ton
  • Budaj, Andrezej
  • Hamm, Christian
  • Spinar, Jindrich
  • Kiss, Robert
  • Lopez-Sendon, José
  • Kamensky, Gabriel
  • Van De Werf, Frans
  • Ardissino, Diego
  • Kontny, Frederic
  • Montalescot, Gilles
  • Johanson, Per
  • Bengtsson, Olof
  • And 3 more
Publication Date
Oct 01, 2019
DOI: 10.1093/ehjcvp/pvz020
PMID: 31218354
OAI: oai:HAL:hal-02341886v1
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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.

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