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

Mikael Dellborg, Marc P. Bonaca, Robert F. Storey, P. Gabriel Steg, Kyung A. Im, Marc Cohen, Deepak L. Bhatt, Ton Oude Ophuis, Andrezej Budaj, Christian Hamm, Jindrich Spinar, R. Kiss, José Lopez-Sendon, Gabriel Kamensky, Frans Van de Werf, Diego Ardissino, Frederic Kontny, Gilles Montalescot, Per Johanson, Olof BengtssonAnders Himmelmann, Eugene Braunwald, Marc S. Sabatine

Research output: Article

2 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)200-206
Number of pages7
JournalEuropean heart journal. Cardiovascular pharmacotherapy
Volume5
Issue number4
DOIs
Publication statusPublished - okt. 1 2019

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Myocardial Infarction
Safety
Hemorrhage
Stroke
Placebos
Purinergic P1 Receptors
Risk Reduction Behavior
Therapeutics
Ticagrelor
Adenosine Diphosphate
Odds Ratio
Clinical Trials
Confidence Intervals
Mortality
Population

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Pharmacology (medical)

Cite this

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 P.; Storey, Robert F.; Steg, P. Gabriel; Im, Kyung A.; Cohen, Marc; Bhatt, Deepak L.; Oude Ophuis, Ton; Budaj, Andrezej; Hamm, Christian; Spinar, Jindrich; Kiss, R.; Lopez-Sendon, José; Kamensky, Gabriel; Van de Werf, Frans; Ardissino, Diego; Kontny, Frederic; Montalescot, Gilles; Johanson, Per; Bengtsson, Olof; Himmelmann, Anders; Braunwald, Eugene; Sabatine, Marc S.

In: European heart journal. Cardiovascular pharmacotherapy, Vol. 5, No. 4, 01.10.2019, p. 200-206.

Research output: Article

Dellborg, M, Bonaca, MP, Storey, RF, Steg, PG, Im, KA, Cohen, M, Bhatt, DL, Oude Ophuis, T, Budaj, A, Hamm, C, Spinar, J, Kiss, R, Lopez-Sendon, J, Kamensky, G, Van de Werf, F, Ardissino, D, Kontny, F, Montalescot, G, Johanson, P, Bengtsson, O, Himmelmann, A, Braunwald, E & Sabatine, MS 2019, 'Efficacy and safety with ticagrelor in patients with prior myocardial infarction in the approved European label: insights from PEGASUS-TIMI 54', European heart journal. Cardiovascular pharmacotherapy, vol. 5, no. 4, pp. 200-206. https://doi.org/10.1093/ehjcvp/pvz020
Dellborg, Mikael ; Bonaca, Marc P. ; Storey, Robert F. ; Steg, P. Gabriel ; Im, Kyung A. ; Cohen, Marc ; Bhatt, Deepak L. ; Oude Ophuis, Ton ; Budaj, Andrezej ; Hamm, Christian ; Spinar, Jindrich ; Kiss, R. ; Lopez-Sendon, José ; Kamensky, Gabriel ; Van de Werf, Frans ; Ardissino, Diego ; Kontny, Frederic ; Montalescot, Gilles ; Johanson, Per ; Bengtsson, Olof ; Himmelmann, Anders ; Braunwald, Eugene ; Sabatine, Marc S. / Efficacy and safety with ticagrelor in patients with prior myocardial infarction in the approved European label : insights from PEGASUS-TIMI 54. In: European heart journal. Cardiovascular pharmacotherapy. 2019 ; Vol. 5, No. 4. pp. 200-206.
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abstract = "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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T1 - Efficacy and safety with ticagrelor in patients with prior myocardial infarction in the approved European label

T2 - insights from PEGASUS-TIMI 54

AU - Dellborg, Mikael

AU - Bonaca, Marc P.

AU - Storey, Robert F.

AU - Steg, P. Gabriel

AU - Im, Kyung A.

AU - Cohen, Marc

AU - Bhatt, Deepak L.

AU - Oude Ophuis, Ton

AU - Budaj, Andrezej

AU - Hamm, Christian

AU - Spinar, Jindrich

AU - Kiss, R.

AU - Lopez-Sendon, José

AU - Kamensky, Gabriel

AU - Van de Werf, Frans

AU - Ardissino, Diego

AU - Kontny, Frederic

AU - Montalescot, Gilles

AU - Johanson, Per

AU - Bengtsson, Olof

AU - Himmelmann, Anders

AU - Braunwald, Eugene

AU - Sabatine, Marc S.

PY - 2019/10/1

Y1 - 2019/10/1

N2 - 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.

AB - 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.

KW - Coronary artery disease

KW - Dual antiplatelet treatment

KW - Post-myocardial infarction

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