Rivaroxaban with or without aspirin in stable cardiovascular disease
Open accessAbstract
BACKGROUND: We evaluated whether rivaroxaban alone or in combination with aspirin would be more effective than aspirin alone for secondary cardiovascular prevention. METHODS: In this double-blind trial, we randomly assigned 27,395 participants with stable atherosclerotic vascular disease to receive rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg once daily), rivaroxaban (5 mg twice daily), or aspirin (100 mg once daily). The primary outcome was a composite of cardiovascular death, stroke, or myocardial infarction. The study was stopped for superiority of the rivaroxaban-plus-aspirin group after a mean follow-up of 23 months. RESULTS: The primary outcome occurred in fewer patients in the rivaroxaban-plus-aspirin group than in the aspirin-alone group (379 patients [4.1%] vs. 496 patients [5.4%]; hazard ratio, 0.76; 95% confidence interval [CI], 0.66 to 0.86; P<0.001; z=-4.126), but major bleeding events occurred in more patients in the rivaroxaban-plus-aspirin group (288 patients [3.1%] vs. 170 patients [1.9%]; hazard ratio, 1.70; 95% CI, 1.40 to 2.05; P<0.001). There was no significant difference in intracranial or fatal bleeding between these two groups. There were 313 deaths (3.4%) in the rivaroxaban-plus-aspirin group as compared with 378 (4.1%) in the aspirin-alone group (hazard ratio, 0.82; 95% CI, 0.71 to 0.96; P=0.01; threshold P value for significance, 0.0025). The primary outcome did not occur in significantly fewer patients in the rivaroxaban-alone group than in the aspirin-alone group, but major bleeding events occurred in more patients in the rivaroxaban-alone group. CONCLUSIONS: Among patients with stable atherosclerotic vascular disease, those assigned to rivaroxaban (2.5 mg twice daily) plus aspirin had better cardiovascular outcomes and more major bleeding events than those assigned to aspirin alone. Rivaroxaban (5 mg twice daily) alone did not result in better cardiovascular outcomes than aspirin alone and resulted in more major bleeding events. (Funded by Bayer; COMPASS ClinicalTrials.gov number, NCT01776424 .).
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The proportional benefit-risk profile of the diabetes sub-group (38% of all patients) was similar to the overall population.
“The proportional benefit-risk profile of the diabetes sub-group (38% of all patients) was similar to the overall population.”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [304]
International Society on Thrombosis and Haemostasis-defined major bleeding, but not fatal or intracranial bleeding, was increased (1.9% vs. 3.1%; HR 1.70; 95% CI, 1.40-2.05; P < 0.001; number needed to harm 83), with a number needed to treat/number needed to harm ratio of 0.9.
“International Society on Thrombosis and Haemostasis-defined major bleeding, but not fatal or intracranial bleeding, was increased (1.9% vs. 3.1%, respectively; HR 1.70; 95% CI, 1.40-2.05;P < 0.001; NNH 83), with an NNT/ NNH ratio of 0.9 (Supplementary data online, Figure S7).”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [304]
Low-dose acetylsalicylic acid combined with very low-dose rivaroxaban (2.5 mg twice daily) was superior to acetylsalicylic acid and placebo in preventing MACE (4.1% vs. 5.4%; HR 0.76; 95% CI, 0.66-0.86; P < 0.001; number needed to treat 77).
“Low-dose ASA combined with very low-dose rivaroxaban (2.5 mg b.i.d.) was superior to ASA and placebo in preventing MACE (4.1% vs. 5.4%, respectively; HR 0.76; 95% CI, 0.66-0.86;P < 0.001; NNT 77).304”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [304]
The COMPASS trial enrolled 27 395 patients with stable ASCVD, including previous myocardial infarction, symptomatic coronary artery disease, and/or peripheral artery disease.
“The COMPASS (Cardiovascular Outcomes for People Using Anticoagulation Strategies) trial enrolled 27 395 patients with stable ASCVD (previous MI, symptomatic CAD, and/or PAD).”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [304]
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- Authors
- Eikelboom, J. W., Connolly, S. J., Bosch, J., Dagenais, G. R., Hart, R. G., Shestakovska, O., Diaz, R., Alings, M., Lonn, E. M., Anand, S. S., Widimsky, P., Hori, M., Avezum, A., Piegas, L. S., Branch, K. R. H., Probstfield, J., Bhatt, D. L., Zhu, J., Liang, Y., Maggioni, A. P., Lopez-Jaramillo, P., O’Donnell, M., Kakkar, A. K., Fox, K. A. A., Parkhomenko, A. N., Ertl, G., Störk, S., Keltai, M., Ryden, L., Pogosova, N., Dans, A. L., Lanas, F., Commerford, P. J., Torp-Pedersen, C., Guzik, T. J., Verhamme, P. B., Vinereanu, D., Kim, J.-H., Tonkin, A. M., Lewis, B. S., Felix, C., Yusoff, K., Steg, P. G., Metsarinne, K. P., Cook Bruns, N., Misselwitz, F., Chen, E., Leong, D., & Yusuf, S.
- Affiliations
- Brigham and Women's Hospital (US)
- Universidad de La Frontera (CL)
- ORCID
- Eikelboom, John W.
- Connolly, Stuart J.
- Bosch, Jackie
- Dagenais, Gilles R.
- Hart, Robert G.
- Shestakovska, Olga
- Alings, Marco
- Lonn, Eva M.
- Anand, Sonia S.
- Hori, Masatsugu
- Piegas, Leopoldo S.
- Branch, Kelley R.H.
- Probstfield, Jeffrey
- Bhatt, Deepak L.
- Zhu, Jun
- Maggioni, Aldo P.
- Kakkar, Ajay K.
- Fox, Keith A.A.
- Parkhomenko, Alexander N.
- Ertl, Georg
- Störk, Stefan
- Lanas, Fernando
- Torp-Pedersen, Christian
- Verhamme, Peter B.
- Tonkin, Andrew M.
- Lewis, Basil S.
- Yusoff, Khalid
- Metsarinne, Kaj P.
- Misselwitz, Frank
- Leong, Darryl
- Yusuf, Salim
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2017-10-05
- Volume
- 377
- Issue
- 14
- Pages
- 1319-1330
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2749380187
- Cited by
- 2,438
- References
- 18
- Citations by year
- 2026: 139 · 2025: 214 · 2024: 242 · 2023: 253 · 2022: 262 · 2021: 328 · 2020: 363 · 2019: 325 · 2018: 242 · 2017: 63 · 2016: 2
- FWCI
- 210.17
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion, other-oa)
- ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (acceptedVersion)
- ARAN (University of Galway Research Repository) (Ollscoil na Gaillimhe – University of Galway) (submittedVersion, cc-by-nc-nd)
- Jagiellonian University Repository (Jagiellonian University) (submittedVersion, other-oa)
- Homo Politicus (Academy of Humanities and Economics in Lodz) (submittedVersion, cc-by-nc-nd)
- Homo Politicus (Academy of Humanities and Economics in Lodz) (submittedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Arrow@dit (Dublin Institute of Technology) (submittedVersion)
- HAL (submittedVersion)
- UCL Discovery (University College London) (submittedVersion)
- Lirias (submittedVersion)
- VBN Forskningsportal (Aalborg Universitet) (submittedVersion)
- Omeka S (Universidad de La Frontera) (submittedVersion, cc-by-nc-nd)
- ARAN (University of Galway Research Repository) (Ollscoil na Gaillimhe – University of Galway) (submittedVersion, cc-by-nc)
- University of Southern Denmark Research Portal (University of Southern Denmark) (submittedVersion, other-oa)
- Research Repository UCD (University College Dublin)
- Research Repository UCD (University College Dublin) (cc-by-nc)
- Funders
- U.S. Department of Veterans Affairs
- Amgen
- Bristol-Myers Squibb
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Sanofi
- Cleveland Clinic
- CSL Behring
- Boston Scientific Corporation
- Regeneron Pharmaceuticals
- Health Research Board (CTN2014-011)
- Ironwood Pharmaceuticals, Incorporated
- Massachusetts Medical Society
- Amarin Corporation
- Fresenius Medical Care North America
- Regado Biosciences
- Belvoir Media Group
- University College London
- Bayer HealthCare
- Agence Nationale de la Recherche (ANR-10-INBS-0003)
- Eisai
- Novo Nordisk
- Astellas Pharma
- Servier
- LEO Pharma
- Daiichi Sankyo Europe
- 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 › Hematology › Blood Coagulation and Thrombosis Mechanisms
- Keywords
- rivaroxaban, aspirin, combination antithrombotic therapy, secondary prevention of cardiovascular disease, major bleeding, cardiovascular mortality, stroke, myocardial infarction, intracranial hemorrhage, bleeding risk, dose comparison, dual antiplatelet therapy, direct oral anticoagulants, cardiovascular outcomes
- MeSH terms
- Rivaroxaban, Aged, Aspirin, Cardiovascular Diseases, Double-Blind Method, Drug Therapy, Combination, Female, Hemorrhage, Humans, Male, Middle Aged, Platelet Aggregation Inhibitors, Atherosclerosis, Secondary Prevention, Factor Xa Inhibitors
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Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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