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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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“After an average follow-up of 33 months, DAPT was associated with a reduction in thrombotic events at the cost of an increase in major bleeding, and there was a trend towards a reduction of cardiovascular mortality with the dose of 60mg twice daily.(36) Age (above or below 75 years) was not shown to have an effect on…”
BackgroundDiabetes and antiplatelet therapy: from bench to bedside
Rios, J. R. R., Franchi, F., Rollini, F., & Angiolillo, D. J. (2018) · Cardiovascular Diagnosis and Therapy · doi:10.21037/cdt.2018.05.09 · Cited by 52
Huo, Y., Jeong, Y., Gong, Y., Wang, D. W., He, B., Chen, J., Fu, G., Chen, Y., Li, J., Li, Y., et al. (2018) · 中国科学通报：英文版 · doi:10.1016/j.scib.2018.12.020 · Cited by 52
Self-citationRivaroxaban Plus Aspirin in Patients With Vascular Disease and Renal Dysfunction
Fox, K. A. A., Eikelboom, J. W., Shestakovska, O., Connolly, S. J., Metsarinne, K. P., & Yusuf, S. (2019) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2019.02.048 · Cited by 56
Causes of late mortality with dual antiplatelet therapy after coronary stents
Mauri, L., Elmariah, S., Yeh, R. W., Cutlip, D. E., Steg, P. G., Windecker, S., Wiviott, S. D., Cohen, D. J., Massaro, J. M., D’Agostino, R. B., et al. (2015) · European Heart Journal · doi:10.1093/eurheartj/ehv614 · Cited by 51
Self-citation1-Year Results of the REMEDEE Registry
Woudstra, P., Kalkman, D. N., den Heijer, P., Menown, I. B. A., Ērglis, A., Suryapranata, H., Arkenbout, K., Íñiguez, A., Hof, A. W. J. V. ’., Müller, P. F., et al. (2016) · JACC: Cardiovascular Interventions · doi:10.1016/j.jcin.2016.02.052 · Cited by 51
How I use laboratory monitoring of antiplatelet therapy
Michelson, A. D., & Bhatt, D. L. (2017) · Blood · doi:10.1182/blood-2017-03-742338 · Cited by 53
Self-citationTavenier, A. H., Mehran, R., Chiarito, M., Cao, D., Pivato, C. A., Nicolas, J., Beerkens, F., Nardin, M., Sartori, S., Baber, U., et al. (2021) · European Heart Journal - Cardiovascular Pharmacotherapy · doi:10.1093/ehjcvp/pvab068 · Cited by 51
Christensen, D. M., Schjerning, A.-M., Smedegaard, L., Charlot, M. G., Ravn, P. B., Ruwald, A., Fosbøl, E. L., Køber, L., Torp-Pedersen, C. T., Schou, M., et al. (2022) · European Heart Journal · doi:10.1093/eurheartj/ehac667 · Cited by 54
“29 In contrast, during the latter part of our study, we found a 12.2% composite 3-year risk using a broader definition of MACE which included all-cause (as opposed to only cardiovascular) mortality as well as hospitalization for HF. Specifically, we also report a 5-year all-cause mortality risk of…”
InfluentialReijnders, E., van der Laarse, A., Jukema, J. W., & Cobbaert, C. M. (2023) · Frontiers in Cardiovascular Medicine · doi:10.3389/fcvm.2023.1264319 · Cited by 55
“The PEGASUS-TIMI 54 trial with ACS patients with stable CAD demonstrated that treatment with P2Y12 inhibitor, ticagrelor, on top of aspirin administration resulted in a 16% reduction in MACE (132, 133).”
MethodClinical Updates in Coronary Artery Disease: A Comprehensive Review
Bottardi, A., Prado, G. F. A., Lunardi, M., Fezzi, S., Pesarini, G., Tavella, D., Scarsini, R., & Ribichini, F. L. (2024) · Journal of Clinical Medicine · doi:10.3390/jcm13164600 · Cited by 60
“On the contrary, in patients at high ischemic risk and without increased risk of major bleeding, DAPT can be extended (>12 months) [155,156] (Figure 3).”
BackgroundGiacoppo, D., Gragnano, F., Watanabe, H., Kimura, T., Kang, J., Park, K. W., Kim, H.-S., Pettersen, A. R., Bhatt, D. L., Pocock, S., et al. (2025) · BMJ · doi:10.1136/bmj-2024-082561 · Cited by 54
Self-citationGalli, M., Franchi, F., Rollini, F., Cavallari, L. H., Capodanno, D., Crea, F., & Angiolillo, D. J. (2021) · Expert Review of Clinical Pharmacology · doi:10.1080/17512433.2021.1927709 · Cited by 50
“The benefits of long-term use of ticagrelor at a 60 mg BID maintenance dose regimen has been confirmed in other studies of high-risk patients such as those with prior MI and diabetes mellitus (DM) [45,46].”
BackgroundAntithrombotic therapy for acute coronary syndrome: Past, present and future
Sibbing, D., Angiolillo, D. J., & Huber, K. (2017) · Thrombosis and Haemostasis · doi:10.1160/th16-12-0963 · Cited by 50
“The observations of a reduced thrombotic risk that comes along with a higher risk of bleeding were not restricted to prasugrel but were also confirmed for potent platelet inhibition with ticagrelor in the PLATO and PEGASUS-TIMI 54 trials (47–49).”
BackgroundInfluentialPrevention of Stroke with Ticagrelor in Patients with Prior Myocardial Infarction
Bonaca, M. P., Goto, S., Bhatt, D. L., Steg, P. G., Storey, R. F., Cohen, M. C., Goodrich, E. L., Mauri, L., Ophuis, T. O., Ruda, M., et al. (2016) · Circulation · doi:10.1161/circulationaha.116.024637 · Cited by 52
Self-citationSingle or dual antiplatelet therapy after PCI
Miyazaki, Y., Suwannasom, P., Sotomi, Y., Abdelghani, M., Tummala, K., Katagiri, Y., Asano, T., Tenekecioğlu, E., Zeng, Y., Cavalcante, R., et al. (2017) · Nature Reviews Cardiology · doi:10.1038/nrcardio.2017.12 · Cited by 47
Zanchin, T., Temperli, F., Karagiannis, A., Zanchin, C., Räsänen, M., Koskinas, K. C., Stortecky, S., Hunziker, L., Praz, F., Blöchlinger, S., et al. (2018) · Circulation Cardiovascular Interventions · doi:10.1161/circinterventions.117.006132 · Cited by 49
Dual antiplatelet therapy in coronary artery disease: from the past to the future prospective
Mangieri, A., Gallo, F., Sticchi, A., Khokhar, A. A., Laricchia, A., Giannini, F., & Colombo, A. (2020) · Cardiovascular Intervention and Therapeutics · doi:10.1007/s12928-020-00642-w · Cited by 49
Marston, N., Pirruccello, J. P., Melloni, G. E. M., Kamanu, F., Bonaca, M. P., Giugliano, R. P., Scirica, B. M., Wiviott, S. D., Bhatt, D. L., Steg, P. G., et al. (2024) · Nature Medicine · doi:10.1038/s41591-024-03188-z · Cited by 47
Self-citationApixaban Plus Mono Versus Dual Antiplatelet Therapy in Acute Coronary Syndromes
Hess, C. N., James, S. K., Lópes, R. D., WOJDYLA, D. M., Neely, M. L., Liaw, D., Hagström, E., Bhatt, D. L., Husted, S., Goodman, S. G., et al. (2015) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2015.06.027 · Cited by 48
Self-citationSahlén, A., Varenhorst, C., Lagerqvist, B., Renlund, H., Wallentin, L. C., James, S. K., & Jernberg, T. (2015) · European Heart Journal - Cardiovascular Pharmacotherapy · doi:10.1093/ehjcvp/pvv034 · Cited by 48
Teng, R., Carlson, G. F., Nylander, S., & Andersson, T. L. G. (2016) · Journal of Thrombosis and Haemostasis · doi:10.1111/jth.13511 · Cited by 48
Dual Antiplatelet Therapy in Coronary Artery Disease
Sharma, R., Kumar, P., Prashanth, S. P., & Belagali, Y. R. (2020) · Cardiology and Therapy · doi:10.1007/s40119-020-00197-0 · Cited by 48
Valgimigli, M., Costa, F., Byrne, R. A., Haude, M., Baumbach, A., & Windecker, S. (2015) · EuroIntervention · doi:10.4244/eijv11i1a11 · Cited by 48
Berger, J. S., Katona, B. G., Jones, W. S., Patel, M. R., Norgren, L., Baumgartner, I., Blomster, J., Mahaffey, K. W., Held, P., Millegård, M., et al. (2016) · American Heart Journal · doi:10.1016/j.ahj.2016.01.018 · Cited by 47
Self-citationAspirin in the primary prevention of cardiovascular disease in diabetes mellitus: A new perspective
Rocca, B., & Patrono, C. (2020) · Diabetes Research and Clinical Practice · doi:10.1016/j.diabres.2020.108008 · Cited by 48
Solid cancers after antiplatelet therapy: Confirmations, controversies, and challenges
Cherepanov, V., Cabrera-Fuentes, H. A., Kim, M. H., & Serebruany, V. L. (2015) · Thrombosis and Haemostasis · doi:10.1160/th15-01-0077 · Cited by 47
Lemesle, G., Tricot, O., Meurice, T., Lallemant, R., Delomez, M., Equine, O., Lamblin, N., & Bauters, C. (2017) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2017.02.050 · Cited by 50
“Indeed, prolonged dual-antiplatelet therapy has shown efficacy in the prevention of incident MI in certain CAD patients (18,19).”
BackgroundManagement of non-culprit coronary plaques in patients with acute coronary syndrome
Montone, R. A., Niccoli, G., Crea, F., & Jang, I. (2020) · European Heart Journal · doi:10.1093/eurheartj/ehaa481 · Cited by 47
Biomarker-Based Prediction of Recurrent Ischemic Events in Patients With Acute Coronary Syndromes
Batra, G., Lindbäck, J., Becker, R. C., Harrington, R. A., Held, C., James, S. K., Kempf, T., Lópes, R. D., Mahaffey, K. W., Steg, P. G., et al. (2022) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2022.08.767 · Cited by 47
Self-citationValgimigli, M., Landi, A., Angiolillo, D. J., Baber, U., Bhatt, D. L., Bonaca, M. P., Capodanno, D., Cohen, D. J., Gibson, C. M., James, S. K., et al. (2024) · Circulation · doi:10.1161/circulationaha.124.069012 · Cited by 49
Self-citationChallenges in secondary prevention after acute myocardial infarction: A call for action
Piepoli, M. F., Corrà, U., Dendale, P., Frederix, I., Prescott, E., Schmid, J. P., Cupples, M., Deaton, C., Doherty, P., Giannuzzi, P., et al. (2017) · European Heart Journal Acute Cardiovascular Care · doi:10.1177/2048872616689773 · Cited by 52
Gencer, B., Li, X. S., Gurmu, Y., Bonaca, M. P., Morrow, D. A., Cohen, M. C., Bhatt, D. L., Steg, P. G., Storey, R. F., Johanson, P., et al. (2020) · Journal of the American Heart Association · doi:10.1161/jaha.119.015331 · Cited by 47
Self-citationCesaro, A., Taglialatela, V., Gragnano, F., Moscarella, E., Fimiani, F., Conte, M., Barletta, V., Monda, E., Limongelli, G., Severino, S., et al. (2020) · Journal of Cardiovascular Pharmacology · doi:10.1097/fjc.0000000000000856 · Cited by 46
“73 m2), (4) multivessel coronary disease (MVD) (stenosis $50% in at least 2 coronary districts), and (5) history of recurrent MI.”
BackgroundMethodInternational patterns of dual antiplatelet therapy duration after acute coronary syndromes
Bueno, H., Pocock, S., Danchin, N., Annemans, L., Gregson, J., Medina, J., & de Werf, F. V. (2016) · Heart · doi:10.1136/heartjnl-2016-309509 · Cited by 45
Pasea, L., Chung, S., Pujades‐Rodríguez, M., Moayyeri, A., Denaxas, S., Fox, K. A. A., Wallentin, L. C., Pocock, S., Timmis, A., Banerjee, A., et al. (2017) · European Heart Journal · doi:10.1093/eurheartj/ehw683 · Cited by 45
“…stroke, or MI) and safety (TIMI major bleeding and fatal or intracranial bleeding) for ticagrelor 60 mg vs. placebo from the PEGASUS-TIMI 54 trial 4 to the validation cohort stratified by predicted risk groups to estimate the potential events prevented and harms caused per 10 000 patients…”
MethodAntiplatelet agents for chronic kidney disease
Natale, P., Palmer, S. C., Saglimbene, V. M., Ruospo, M., Razavian, M., Craig, J. C., Jardine, M., Webster, A. C., & Strippoli, G. F. (2022) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd008834.pub4 · Cited by 45
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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