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Long-Term Use of Ticagrelor in Patients with Prior Myocardial Infarction
Open accessAbstract
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”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [317]
In the citing paper
“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]
In the citing paper
“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]
In the citing paper
“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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“Moreover, the discontinuation rate of the 2 ticagrelor groups was significantly higher than that of the placebo group.(52) In addition, the 60-mg twice-daily dosage was better tolerated than the higher 90-mg twice-daily dosage: the lower dosage had a smaller incidence of bleeding and dyspnea.”
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Is P2Y12 inhibitor therapy associated with an increased risk of cancer?
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“Both ticagrelor groups had a significant reduction in major adverse cardiovascular events (MACE) of cardiovascular death, MI, or stroke and a significant increase in major bleeding as compared with placebo.(7)”
BackgroundEndogenous fibrinolysis in STEMI: important before and after primary PCI
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“) compared to the control arm (aspirin monotherapy), including both cardiovascular and coronary heart disease mortality in the DM subgroup, although with the counterpart of a heightened risk of major bleeding (32, 33).”
ResultMarschall, A., Rivero, F., del Val, D., Bastante, T., Soberon, E. L., Sánchez, I. G., Velasco, E. B., Alfonso, F., Hernández, J. M. D. L. T., & Sánchez, D. M. (2025) · Journal of Clinical Medicine · doi:10.3390/jcm14041194 · Cited by 7
“…therapy after drug-eluting stents (DAPT) and the long-term use of ticagrelor in patients with prior myocardial infarction (PEGASUS-TIMI 54) trials, extending DAPT beyond 12 months should be considered for patients with high ischemic risk provided they are not at high risk of bleeding [53,55].”
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“…clinical efficacy, ticagrelor therapy has some limitations, such as an increased risk of non-procedure-related bleeding [14], major bleeding events [17], dyspnea [18], and patient adherence issues either due to its twice-daily dosing regimen or these side effects, particularly in fragile patients…”
Antiplatelet Therapy in Heart Disease
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“Prolonged DAPT with P2Y 12 inhibitors (mostly clopidogrel and ticagrelor) for up to 30–36 months has been shown to reduce primary ischemic end points in patients with high ischemic risk and without HBR, although this benefit comes with an increased bleeding risk [92,108].”
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“This conclusion was also supported by the prospective assessment of cancer in the TRILOGY trial [65], which showed no excess of cancers with ticagrelor 90 mg of ticagrelor as in in the PLATO trial with clopidogrel [62].”
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“Apart from history of a recent MI (13), which was prospectively evaluated, retrospective analyses have identified prior history of heart failure, certain cardiovascular risk factors, and interventional characteristics as predictors of potential benefit of prolonged DAPT (15).”
BackgroundInfluentialLuca, L. D., Colivicchi, F., Gulizia, M. M., Pugliese, F. R., Ruggieri, M. P., Musumeci, G., Cibinel, G. A., & Romeo, F. (2017) · European Heart Journal Supplements · doi:10.1093/eurheartj/sux013 · Cited by 7
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“Of note, the lower-dose ticagrelor arm was better tolerated than the higher dose ticagrelor arm with regard to both bleeding events and dyspnea [75].”
BackgroundMethodPredictive Model of Internal Bleeding in Elderly Aspirin Users Using XGBoost Machine Learning
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“the CHARISMA study, and in the PEGASUS-TIMI 54 and TRA 2P-TIMI 50 trials, compared with control groups, DAPT significantly reduced the risk of MACE, but not CV death [11,13,14].”
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“The study protocol was approved by the ethics committees of Seoul National University Hospital Institutional Review Board (IRB) (1404-142-576), Presbyterian Medical Center IRB (2014-12-052), Pusan National University Yangsan Hospital IRB (03-2015-003), Hanyang University Seoul Hospital IRB (2014-10-027-001), Hanlim Ge…”
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Antithrombotic Therapy in Elderly Patients with Acute Coronary Syndromes
Bonanad, C., Claramunt, F. E., García‐Blas, S., Ayesta, A., Díez‐Villanueva, P., Pérez-Rivera, J.-Á., Ferreiro, J. L., Cànoves, J., López-Fornás, F. J., Ariza‐Solé, A., et al. (2022) · Journal of Clinical Medicine · doi:10.3390/jcm11113008 · Cited by 7
“In addition, the study excluded all patients at high risk of bleeding, such as those with a previous history of stroke or a history of recent bleeding [13].”
BackgroundResultPeng, W., Zhang, Y., & Yang, L. (2022) · Frontiers in Cardiovascular Medicine · doi:10.3389/fcvm.2022.937261 · Cited by 7
Lahu, S., Scalamogna, M., Ndrepepa, G., Menichelli, M., Valina, C. M., Hemetsberger, R., Witzenbichler, B., Bernlochner, I., Joner, M., Xhepa, E., et al. (2022) · Journal of the American Heart Association · doi:10.1161/jaha.122.027257 · Cited by 7
Off-Target Effects of P2Y12 Receptor Inhibitors: Focus on Early Myocardial Fibrosis Modulation
Lofrumento, F., Irrera, N., Licordari, R., Perfetti, S., Nasso, E., Liotta, P., Isgrò, G., Garcia-Ruiz, V., Squadrito, F., Carerj, S., et al. (2023) · International Journal of Molecular Sciences · doi:10.3390/ijms242417546 · Cited by 8
“However, this beneficial effect did not manifest in the PEGASUS trial, where there was a numerical increase in deaths attributed to infections in the 90 mg ticagrelor group when compared to the 60 mg ticagrelor and placebo groups [37].”
MethodSafety of Antithrombotic Agents in Elderly Patients with Acute Coronary Syndromes
Rocca, B., & Husted, S. (2016) · Drugs & Aging · doi:10.1007/s40266-016-0359-0 · Cited by 7
Jackson, L. R., Piccini, J. P., Cyr, D. D., Roe, M. T., Neely, M. L., Martínez, F. A., Lüscher, T. F., Lópes, R. D., Winters, K. J., White, H. D., et al. (2016) · Clinical Cardiology · doi:10.1002/clc.22562 · Cited by 7
Self-citationRusso, J. J., Goodman, S. G., Bagai, A., Déry, J., Tan, M., Fisher, H. N., Zhang, X., Zhu, Y. E., Welsh, R. C., Siega, A. D., et al. (2016) · European Heart Journal - Quality of Care and Clinical Outcomes · doi:10.1093/ehjqcco/qcw051 · Cited by 7
Keloid scars: the hidden burden of disease
Lemonas, P., & Ahmad, I. (2015) · Journal of Pigmentary Disorders · doi:10.4172/2376-0427.1000231 · Cited by 7
Personalizing antiplatelet therapies: What have we learned from recent trials?
Landry, S., Tanguay, J., & Lordkipanidzé, M. (2017) · Platelets · doi:10.1080/09537104.2017.1320372 · Cited by 7
Medikamentenfreisetzende Koronarstents/-scaffolds und medikamentenbeschichtete Ballonkatheter
NEF, H. M., Abdel‐Wahab, M., Achenbach, S. S., Joner, M., Levenson, B., Mehilli, J., Möllmann, H., Thiele, H., Zahn, R., Zeus, T., et al. (2017) · Der Kardiologe · doi:10.1007/s12181-017-0202-9 · Cited by 7
Patrono, C. (2017) · Cardiovascular Research · doi:10.1093/cvr/cvx209 · Cited by 6
“0% in the PEGASUS trial.(8) Within this context, the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial was designed to test the hypothesis that rivaroxaban (a direct factor Xa inhibitor: 2.”
BackgroundDual antiplatelet therapy in patients with an acute coronary syndrome: up to 12 months and beyond
Pareek, M., & Bhatt, D. L. (2018) · European Heart Journal Supplements · doi:10.1093/eurheartj/sux042 · Cited by 7
Self-citationSandinge, A.-S., Janefeldt, A., Pehrsson, S., & Nylander, S. (2018) · PLoS ONE · doi:10.1371/journal.pone.0201202 · Cited by 7
Riva, L., Ageno, W., Pasquale, G. D., Agnelli, G., & Rubboli, A. (2018) · International Journal of Cardiology · doi:10.1016/j.ijcard.2018.07.133 · Cited by 7
Esposti, L. D., Perrone, V., Veronesi, C., Buda, S., Rossini, R., & on Behalf of a LHUs Group (2018) · TH Open · doi:10.1055/s-0038-1676529 · Cited by 7
Kim, H. K., Kim, H. B., Lee, J. M., Kim, S. S., Bae, I., Park, D. S., Park, J., Shim, J. W., Na, J., Lee, M. Y., et al. (2019) · Journal of Korean Medical Science · doi:10.3346/jkms.2019.34.e145 · Cited by 7
Huang, D., Cheng, Y. Y., Wong, Y. T. A., Yung, S. Y. A., Chan, K. W. K., Lam, C. C. S., Hai, J. J., Lau, C., Wong, K. L., Feng, Y., et al. (2019) · Postgraduate Medical Journal · doi:10.1136/postgradmedj-2019-136404 · Cited by 7
P2Y12 inhibitors: do they increase cancer risk?
Fierro, J. J., Cave, B. E., & Khouzam, R. N. (2019) · Annals of Translational Medicine · doi:10.21037/atm.2019.07.90 · Cited by 7
Antithrombotic Treatment After Coronary Intervention: Agreement and Controversy
Camarero, T. G., & Hernández, J. M. D. L. T. (2020) · European Cardiology Review · doi:10.15420/ecr.2019.25.2 · Cited by 7
Verdoia, M., Camaro, C., Kedhi, E., Marcolongo, M., Suryapranata, H., & Luca, G. D. (2020) · Cardiovascular Therapeutics · doi:10.1155/2020/6495036 · Cited by 8
“In the PEGASUS trial [46], a total of 21,162 patients with a previous (1 to 3 years earlier) myocardial infarction were randomly assigned 1 :1 :1 fashion to ticagrelor 90mg twice daily, ticagrelor 60mg twice daily, or placebo and followed up for a median of 33 months.”
MethodSynnott, P. G., McQueen, R. B., Ollendorf, D. A., Campbell, J. D., & Pearson, S. D. (2020) · Journal of Managed Care & Specialty Pharmacy · doi:10.18553/jmcp.2020.26.6.782 · Cited by 7
Risk of bradyarrhythmia related to ticagrelor: A systematic review and meta-analysis
Pujade, I., Perino, J., Mathieu, C., Arnaud, M., Raschi, E., Gatti, M., Bezin, J., & Salvo, F. (2020) · Pharmacological Research · doi:10.1016/j.phrs.2020.105089 · Cited by 7
Tan, J. W. C., Chew, D. P., Tsui, K. L., Tan, D. S., Duplyakov, D. V., Hammoudeh, A. J., Zhang, B., Li, Y., Xu, K., Ong, P. J. L., et al. (2021) · European Cardiology Review · doi:10.15420/ecr.2021.35 · Cited by 7
Self-citationLin, Y., Cai, Z., Dong, S., Liu, H., Pang, X., Chen, Q., Yuan, J., & Geng, Q. (2022) · Frontiers in Pharmacology · doi:10.3389/fphar.2022.992376 · Cited by 8
“, 2019) and BARC type ≥ 3 in two studiers (Bonaca et al., 2015; Koo et al., 2021).”
BackgroundMethodManagement Strategies for Clopidogrel Hypersensitivity
Beavers, C. J., Carris, N. W., & Ruf, K. M. (2015) · Drugs · doi:10.1007/s40265-015-0414-x · Cited by 7
“However, data to support the use of ticagrelor in more remote ACS is increasing, though it would still constitute an off-label use [51].”
Association Between Administration of Ticagrelor and Microvascular Endothelial Function
Lavi, S., Alemayehu, M., Puka, K., Wall, S., & Lavi, R. (2017) · JAMA Cardiology · doi:10.1001/jamacardio.2017.2378 · Cited by 7
Antiplatelet Therapy in Diabetes
Majithia, A., & Bhatt, D. L. (2017) · Endocrinology and Metabolism Clinics of North America · doi:10.1016/j.ecl.2017.10.009 · Cited by 7
Self-citationRoth, C., Schneider, M., Dalos, D., Gangl, C., Toth, C., Goliasch, G., & Berger, R. (2019) · Journal of Clinical Medicine · doi:10.3390/jcm8060898 · Cited by 7
“However, the extension of dual anti-plateled therapy may be a better way to improve survival in these patients [25].”
BackgroundImam, H., Nguyen, T. H. T., Caterina, R. D., Nooney, V. B., Chong, C., Horowitz, J. D., & Chirkov, Y. Y. (2019) · Thrombosis Research · doi:10.1016/j.thromres.2019.07.016 · Cited by 8
Estimation on conditional restricted mean survival time with counting process
Qiu, J., Gu, E., Zhou, D., Lawrence, J., Bai, S., & Hung, H. M. J. (2019) · Journal of Biopharmaceutical Statistics · doi:10.1080/10543406.2019.1657129 · Cited by 7
“PEGASUS (Bonaca et al. 2015) was a randomized, double-blind, placebo-controlled, parallel-group trial conducted to determine whether long-term dual anti-platelet therapy with ticagrelor 90 or 60 mg twice daily is superior to placebo.”
MethodLuca, L. D., Colivicchi, F., Meessen, J. M. T. A., Uguccioni, M., Piscione, F., Bernabò, P., Lardieri, G., Granatelli, A., Gabrielli, D., Gulizia, M. M., et al. (2019) · Clinical Cardiology · doi:10.1002/clc.23262 · Cited by 7
“This recommendation is based on recent randomized clinical trials suggesting that DAPT prolongation reduces the rate of recurrent ischemic events in post-MI patients, compared with aspirin alone.(3,4) However, these benefits come at the cost of increased risk of bleeding, raising the question about how to identify the…”
More transparency for a therapeutic window in platelet P2Y12inhibition?
Storey, R. F. (2015) · European Heart Journal · doi:10.1093/eurheartj/ehv137 · Cited by 8
Self-citation2017 ESC guidelines focus on dual antiplatelet therapy
Rosano, G. M. C., & Seferovic, P. M. (2018) · European Heart Journal - Cardiovascular Pharmacotherapy · doi:10.1093/ehjcvp/pvy007 · Cited by 7
Critical appraisal of the COMPASS trial
Niessner, A., & Agewall, S. (2018) · European Heart Journal - Cardiovascular Pharmacotherapy · doi:10.1093/ehjcvp/pvy027 · Cited by 7
Erzinger, F. L., Polimanti, A. C., Pinto, D. M., Murta, G. B., Cury, M. V. M., da Silva, R. B., Biagioni, R. B., Belczak, S. Q., Joviliano, E. É., de Araújo, W. J. B., et al. (2024) · Jornal Vascular Brasileiro · doi:10.1590/1677-5449.202300591 · Cited by 7
“No entanto, dados do estudo PEGASUS-TIMI 93,94 provam que, em pacientes com DAP com infarto do miocárdio prévio, um subgrupo selecionado de alto risco isquêmico, a terapia antiplaquetária dupla (TAD) com aspirina e ticagrelor de baixa dose (60 mg duas vezes ao dia) está associada à redução de MACE…”
Nebiolo, M., Kang, J., Sandrone, S., Kim, H. K., Mattesini, A., Lee, S. Y., Piccolo, R., Lim, Y., Perl, L., Youn, Y. J., et al. (2025) · International Journal of Cardiology · doi:10.1016/j.ijcard.2025.133542 · Cited by 6
Kovacevic, M., Jones, D. A., Thiele, H., Steg, P. G., & Kunadian, V. (2025) · EuroIntervention · doi:10.4244/eij-d-25-00100 · Cited by 8
Self-citation
Metadata
- 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
- 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 › Cardiology and Cardiovascular Medicine › 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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