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Ticagrelor with or without Aspirin in High-Risk Patients after PCI

Open access
Mehran, Roxana, Baber, Usman, Sharma, Samin K., Cohen, David J., Angiolillo, Dominick J., Briguori, Carlo, Cha, Jin Y., Collier, Timothy, Dangas, George, Dudek, Dariusz, Džavík, Vladimír, Escaned, Javier, Gil, Robert, Gurbel, Paul, Hamm, Christian W., Henry, Timothy, Huber, Kurt, Kastrati, Adnan, Kaul, Upendra, Kornowski, Ran, Krucoff, Mitchell, Kunadian, Vijay, Marx, Steven O., Mehta, Shamir R., Moliterno, David, Ohman, E. Magnus, Oldroyd, Keith, Sardella, Gennaro, Sartori, Samantha, Shlofmitz, Richard, Steg, P. Gabriel, Weisz, Giora, Witzenbichler, Bernhard, Han, Ya-ling, Pocock, Stuart, Gibson, C. Michael·2019·New England Journal of Medicine

Abstract

BACKGROUND: inhibitor after a minimum period of dual antiplatelet therapy is an emerging approach to reduce the risk of bleeding after percutaneous coronary intervention (PCI). METHODS: In a double-blind trial, we examined the effect of ticagrelor alone as compared with ticagrelor plus aspirin with regard to clinically relevant bleeding among patients who were at high risk for bleeding or an ischemic event and had undergone PCI. After 3 months of treatment with ticagrelor plus aspirin, patients who had not had a major bleeding event or ischemic event continued to take ticagrelor and were randomly assigned to receive aspirin or placebo for 1 year. The primary end point was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding. We also evaluated the composite end point of death from any cause, nonfatal myocardial infarction, or nonfatal stroke, using a noninferiority hypothesis with an absolute margin of 1.6 percentage points. RESULTS: We enrolled 9006 patients, and 7119 underwent randomization after 3 months. Between randomization and 1 year, the incidence of the primary end point was 4.0% among patients randomly assigned to receive ticagrelor plus placebo and 7.1% among patients assigned to receive ticagrelor plus aspirin (hazard ratio, 0.56; 95% confidence interval [CI], 0.45 to 0.68; P<0.001). The difference in risk between the groups was similar for BARC type 3 or 5 bleeding (incidence, 1.0% among patients receiving ticagrelor plus placebo and 2.0% among patients receiving ticagrelor plus aspirin; hazard ratio, 0.49; 95% CI, 0.33 to 0.74). The incidence of death from any cause, nonfatal myocardial infarction, or nonfatal stroke was 3.9% in both groups (difference, -0.06 percentage points; 95% CI, -0.97 to 0.84; hazard ratio, 0.99; 95% CI, 0.78 to 1.25; P<0.001 for noninferiority). CONCLUSIONS: Among high-risk patients who underwent PCI and completed 3 months of dual antiplatelet therapy, ticagrelor monotherapy was associated with a lower incidence of clinically relevant bleeding than ticagrelor plus aspirin, with no higher risk of death, myocardial infarction, or stroke. (Funded by AstraZeneca; TWILIGHT ClinicalTrials.gov number, NCT02270242.).

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Metadata

Authors
Mehran, R., Baber, U., Sharma, S. K., Cohen, D. J., Angiolillo, D. J., Briguori, C., Cha, J. Y., Collier, T., Dangas, G., Dudek, D., Džavík, V., Escaned, J., Gil, R., Gurbel, P., Hamm, C. W., Henry, T., Huber, K., Kastrati, A., Kaul, U., Kornowski, R., Krucoff, M., Kunadian, V., Marx, S. O., Mehta, S. R., Moliterno, D., Ohman, E. M., Oldroyd, K., Sardella, G., Sartori, S., Shlofmitz, R., Steg, P. G., Weisz, G., Witzenbichler, B., Han, Y.-L., Pocock, S., & Gibson, C. M.
Venue
New England Journal of Medicine
Published
2019-11-21
Volume
381
Issue
21
Pages
2032-2042
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2976166882
Cited by
1,039
References
30
FWCI
100.09
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: Ticagrelor with or without Aspirin in High-Risk Patients after PCI. https://app.cochat.ai/papers/10.1056/nejmoa1908419
The paper
Mehran, R., Baber, U., Sharma, S. K., Cohen, D. J., Angiolillo, D. J., Briguori, C., Cha, J. Y., Collier, T., Dangas, G., Dudek, D., Džavík, V., Escaned, J., Gil, R., Gurbel, P., Hamm, C. W., Henry, T., Huber, K., Kastrati, A., Kaul, U., . . . Gibson, C. M. (2019). Ticagrelor with or without Aspirin in High-Risk Patients after PCI. New England Journal of Medicine. https://doi.org/10.1056/nejmoa1908419

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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.

Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.