Long-term use of ticagrelor in patients with prior myocardial infarction
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BACKGROUND: The potential benefit of dual antiplatelet therapy beyond 1 year after a myocardial infarction has not been established. We investigated the efficacy and safety of ticagrelor, a P2Y12 receptor antagonist with established efficacy after an acute coronary syndrome, in this context. METHODS: We randomly assigned, in a double-blind 1:1:1 fashion, 21,162 patients who had had a myocardial infarction 1 to 3 years earlier to ticagrelor at a dose of 90 mg twice daily, ticagrelor at a dose of 60 mg twice daily, or placebo. All the patients were to receive low-dose aspirin and were followed for a median of 33 months. The primary efficacy end point was the composite of cardiovascular death, myocardial infarction, or stroke. The primary safety end point was Thrombolysis in Myocardial Infarction (TIMI) major bleeding. RESULTS: The two ticagrelor doses each reduced, as compared with placebo, the rate of the primary efficacy end point, with Kaplan-Meier rates at 3 years of 7.85% in the group that received 90 mg of ticagrelor twice daily, 7.77% in the group that received 60 mg of ticagrelor twice daily, and 9.04% in the placebo group (hazard ratio for 90 mg of ticagrelor vs. placebo, 0.85; 95% confidence interval [CI], 0.75 to 0.96; P=0.008; hazard ratio for 60 mg of ticagrelor vs. placebo, 0.84; 95% CI, 0.74 to 0.95; P=0.004). Rates of TIMI major bleeding were higher with ticagrelor (2.60% with 90 mg and 2.30% with 60 mg) than with placebo (1.06%) (P<0.001 for each dose vs. placebo); the rates of intracranial hemorrhage or fatal bleeding in the three groups were 0.63%, 0.71%, and 0.60%, respectively. CONCLUSIONS: In patients with a myocardial infarction more than 1 year previously, treatment with ticagrelor significantly reduced the risk of cardiovascular death, myocardial infarction, or stroke and increased the risk of major bleeding. (Funded by AstraZeneca; PEGASUS-TIMI 54 ClinicalTrials.gov number, NCT01225562.).
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No sufficient safety and efficacy data are available for DAPT with reduced-dose ticagrelor beyond 3 years.
“No sufficient safety and efficacy data are available for DAPT with reduced-dose ticagrelor beyond 3 years”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [317]
Reduced-dose ticagrelor (60 mg) decreased MACE compared with placebo (7.77% vs. 9.04%; HR 0.84; 95% CI, 0.74-0.95; P = 0.004; NNT 79), with no heterogeneity with respect to the diabetes sub-group.
“Reduced-dose ticagrelor (60 mg) decreased MACE compared with placebo (7.77% vs. 9.04%, respectively; HR 0.84; 95% CI, 0.74-0.95;P = 0.004; NNT 79), with no heterogeneity with respect to the diabetes sub-group”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [317]
Reduced-dose ticagrelor significantly increased TIMI major bleeding compared with placebo (2.3% vs. 1.06%; HR 2.32; 95% CI, 1.68-3.21; NNH 81).
“whereas it significantly increased TIMI major bleeding (2.3% vs. 1.06%, respectively; HR 2.32; 95% CI, 1.68-3.21;NNH 81)”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [317]
Reduced-dose ticagrelor significantly increased dyspnoea, serious adverse events, and drug discontinuation rates.
“dyspnoea, serious adverse events, and drug discontinuation rates.317”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [317]
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- Authors
- Bonaca, M. P., Bhatt, D. L., Cohen, M., Steg, P. G., Storey, R. F., Jensen, E. C., Magnani, G., Bansilal, S., Fish, M. P., Im, K., Bengtsson, O., Ophuis, T. O., Budaj, A., Theroux, P., Ruda, M., Hamm, C., Goto, S., Spinar, J., Nicolau, J. C., Kiss, R. G., Murphy, S. A., Wiviott, S. D., Held, P., Braunwald, E., & Sabatine, M. S.
- Affiliations
- Newark Beth Israel Medical Center (US)
- Brigham and Women's Hospital (US)
- University of Sheffield (GB)
- AstraZeneca (Sweden) (SE)
- Icahn School of Medicine at Mount Sinai (US)
- Canisius-Wilhelmina Ziekenhuis (NL)
- Grochowski Hospital (PL)
- National Medical Research Center of Cardiology (RU)
- Justus-Liebig-Universität Gießen (DE)
- Tokai University (JP)
- Universidade de São Paulo (BR)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2015-05-07
- Volume
- 372
- Issue
- 19
- Pages
- 1791-1800
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2141358924
- Cited by
- 1,999
- References
- 32
- Citations by year
- 2026: 86 · 2025: 99 · 2024: 102 · 2023: 130 · 2022: 163 · 2021: 189 · 2020: 232 · 2019: 205 · 2018: 220 · 2017: 222 · 2016: 236 · 2015: 108 · 2013: 1 · 2012: 1
- FWCI
- 188.81
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- SZTE Publicatio Repozitórium (University of Szeged) (acceptedVersion, other-oa)
- Open Repository and Bibliography (University of Liège) (submittedVersion, other-oa)
- HAL (submittedVersion)
- University of Debrecen Electronic Archive (University of Debrecen) (submittedVersion, other-oa)
- Digital Access to Libraries (submittedVersion)
- Adelaide Research & Scholarship (AR&S) (University of Adelaide) (submittedVersion)
- Use Siena air (University of Siena) (submittedVersion)
- Funders
- Japan Society for the Promotion of Science (24390202)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Antiplatelet Therapy and Cardiovascular Diseases
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Acute Myocardial Infarction Research
- Health Sciences › Medicine › Surgery › Coronary Interventions and Diagnostics
- Keywords
- ticagrelor, P2Y12 inhibitors, old myocardial infarction, dual antiplatelet therapy, long-term antiplatelet therapy, cardiovascular mortality, myocardial infarction, stroke, intracranial hemorrhage, aspirin, dose comparison, secondary prevention, bleeding risk, cardiovascular risk reduction
- MeSH terms
- Ticagrelor, Adenosine, Aged, Aspirin, Cardiovascular Diseases, Double-Blind Method, Drug Administration Schedule, Drug Therapy, Combination, Female, Hemorrhage, Humans, Male, Middle Aged, Myocardial Infarction, Platelet Aggregation Inhibitors, Risk, Intracranial Hemorrhages, Kaplan-Meier Estimate, Secondary Prevention, Purinergic P2Y Receptor Antagonists
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