Clinical characteristics and outcomes with rivaroxaban vs. warfarin in patients with non-valvular atrial fibrillation but underlying native mitral and aortic valve disease participating in the ROCKET AF trial
Open accessAbstract
AIMS: We investigated clinical characteristics and outcomes of patients with significant valvular disease (SVD) in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) trial. METHODS AND RESULTS: ROCKET AF excluded patients with mitral stenosis or artificial valve prostheses. We used Cox regression to adjust comparisons for potential confounders. Among 14 171 patients, 2003 (14.1%) had SVD; they were older and had more comorbidities than patients without SVD. The rate of stroke or systemic embolism with rivaroxaban vs. warfarin was consistent among patients with SVD [2.01 vs. 2.43%; hazard ratio (HR) 0.83, 95% confidence interval (CI) 0.55-1.27] and without SVD (1.96 vs. 2.22%; HR 0.89, 95% CI 0.75-1.07; interaction P = 0.76). However, rates of major and non-major clinically relevant bleeding with rivaroxaban vs. warfarin were higher in patients with SVD (19.8% rivaroxaban vs. 16.8% warfarin; HR 1.25, 95% CI 1.05-1.49) vs. those without (14.2% rivaroxaban vs. 14.1% warfarin; HR 1.01, 95% CI 0.94-1.10; interaction P = 0.034), even when controlling for risk factors and potential confounders. In intracranial haemorrhage, there was no interaction between patients with and without SVD where the overall rate was lower among those randomized to rivaroxaban. CONCLUSIONS: Many patients with 'non-valvular atrial fibrillation' have significant valve lesions. Their risk of stroke is similar to that of patients without SVD after controlling for stroke risk factors. Efficacy of rivaroxaban vs. warfarin was similar in patients with and without SVD; however, the observed risk of bleeding was higher with rivaroxaban in patients with SVD but was the same among those without SVD. Atrial fibrillation patients with and without SVD experience the same stroke-preventive benefit of oral anticoagulants.
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
NOACs appear to be equally effective as VKAs in patients with moderate aortic stenosis, based on a subanalysis from the ROCKET-AF trial as well as the Loire Valley AF project.
“NOACs appear to be equally effective as VKAs in patients with moderate aortic stenosis, based on a subanalysis from the ROCKET-AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) trial 1032 as well as the Loire Valley AF project.1033”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [1032]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
Dabigatran versus warfarin in patients with atrial fibrillation
Connolly, S. J., Ezekowitz, M. D., Yusuf, S., Eikelboom, J., Oldgren, J., Parekh, A., Pogue, J., Reilly, P. A., Themeles, E., Varrone, J., et al. (2009) · New England Journal of Medicine · doi:10.1056/nejmoa0905561 · Cited by 11,215 · see citing works
Rivaroxaban versus warfarin in nonvalvular atrial fibrillation
Patel, M. R., Mahaffey, K. W., Garg, J., Pan, G., Singer, D. E., Hacke, W., Breithardt, G., Halperin, J. L., Hankey, G. J., Piccini, J. P., et al. (2011) · New England Journal of Medicine · doi:10.1056/nejmoa1009638 · Cited by 9,430 · see citing works
Self-citationApixaban versus warfarin in patients with atrial fibrillation
Granger, C. B., Alexander, J. H., McMurray, J. J. V., Lopes, R. D., Hylek, E. M., Hanna, M., Al-Khalidi, H. R., Ansell, J., Atar, D., Avezum, A., et al. (2011) · New England Journal of Medicine · doi:10.1056/nejmoa1107039 · Cited by 8,943 · see citing works
2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation
January, C. T., Wann, L. S., Alpert, J. S., Calkins, H. G., Cigarroa, J. E., Cleveland, J. C., CONTI, J. B., Ellinor, P. T., Ezekowitz, M. D., Field, M. E., et al. (2014) · Circulation · doi:10.1161/cir.0000000000000041 · Cited by 7,119 · see citing works
Edoxaban versus warfarin in patients with atrial fibrillation
Giugliano, R. P., Ruff, C. T., Braunwald, E., Murphy, S. A., Wiviott, S. D., Halperin, J. L., Waldo, A. L., Ezekowitz, M. D., Weitz, J. I., Špinar, J., et al. (2013) · New England Journal of Medicine · doi:10.1056/nejmoa1310907 · Cited by 5,164 · see citing works
Pisters, R., Lane, D. A., Nieuwlaat, R., de Vos, C. B., Crijns, H. J. G. M., & Lip, G. Y. H. (2010) · CHEST Journal · doi:10.1378/chest.10-0134 · Cited by 4,517 · see citing works
2012 focused update of the ESC Guidelines for the management of atrial fibrillation
Authors Task Force Members, Camm, A. J., Lip, G. Y. H., Caterina, R. D., Savelieva, I., Atar, D., Hohnloser, S. H., Hindricks, G., Kirchhof, P. F., Bax, J. J., et al. (2012) · EP Europace · doi:10.1093/europace/eus305 · Cited by 3,814 · see citing works
Self-citation2012 focused update of the ESC Guidelines for the management of atrial fibrillation
Authors Task Force Members, Camm, A. J., Lip, G. Y. H., Caterina, R. D., Savelieva, I., Atar, D., Hohnloser, S. H., Hindricks, G., Kirchhof, P. F., Bax, J. J., et al. (2012) · European Heart Journal · doi:10.1093/eurheartj/ehs253 · Cited by 2,898 · see citing works
Self-citationApixaban in patients with atrial fibrillation
Connolly, S. J., Eikelboom, J., Joyner, C., Diener, H.-C., Hart, R., Golitsyn, S., Flaker, G., Avezum, A., Hohnloser, S. H., Diaz, R., et al. (2011) · New England Journal of Medicine · doi:10.1056/nejmoa1007432 · Cited by 2,483 · see citing works
Effect of clopidogrel added to aspirin in patients with atrial fibrillation
The ACTIVE Investigators (2009) · New England Journal of Medicine · doi:10.1056/nejmoa0901301 · Cited by 2,102 · see citing works
January, C. T., Wann, L. S., Alpert, J. S., Calkins, H., Cigarroa, J. E., Cleveland, J. C., Conti, J. B., Ellinor, P. T., Ezekowitz, M. D., Field, M. E., et al. (2014) · Circulation · doi:10.1161/cir.0000000000000040 · Cited by 2,056 · see citing works
Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation
Blackshear, J. L., & Odell, J. A. (1996) · The Annals of Thoracic Surgery · doi:10.1016/0003-4975(95)00887-x · Cited by 1,686 · cited 1× · see citing works
“Among patients with rheumatic AF, about half of thrombi were found in the left atrial appendage and the rest in its cavity, whereas in non-valvular AF, thrombi were predominantly found in the left atrial appendage.(22) This difference in location of thrombi may influence outcomes and efficacy of anticoagulant therapy.”
BackgroundLip, G. Y. H., Frison, L., Halperin, J. L., & Lane, D. A. (2010) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2010.09.024 · Cited by 1,077 · see citing works
Self-citationAtrial fibrillation management: a prospective survey in ESC Member Countries
Nieuwlaat, R., Capucci, A., Camm, A. J., Olsson, S. B., Andresen, D., Davies, D. W., Cobbe, S. M., BREITHARDT, G. E., Heuzey, J. L., Prins, M. H., et al. (2005) · European Heart Journal · doi:10.1093/eurheartj/ehi505 · Cited by 825 · see citing works
Self-citation2012 Focused Update of the ESC Guidelines for the Management of Atrial Fibrillation
Camm, A. J., Lip, G. Y. H., Caterina, R. D., Savelieva, I., Atar, D., Hohnloser, S. H., Hindricks, G., & Kirchhof, P. F. (2012) · Revista Española de Cardiología (English Edition) · doi:10.1016/j.rec.2012.11.003 · Cited by 687 · see citing works
ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation: full text
Fuster, V., Rydén, L., Cannom, D. S., Crijns, H. J. G. M., Curtis, A. B., Ellenbogen, K. A., Halperin, J. L., Heuzey, J. L., Kay, G. N., Lowe, J. E., et al. (2006) · EP Europace · doi:10.1093/europace/eul097 · Cited by 663 · see citing works
Self-citationRuff, C. T., Giugliano, R. P., Antman, E. M., Crugnale, S. E., Bocanegra, T. S., Mercuri, M. F., HANYOK, J. J., Patel, I. J., Shi, M., Salazar, D., et al. (2010) · American Heart Journal · doi:10.1016/j.ahj.2010.06.042 · Cited by 480 · see citing works
The Executive Steering Committee, O. B. O. T. R. A. S. I. (2010) · American Heart Journal · doi:10.1016/j.ahj.2009.11.025 · Cited by 476 · see citing works
Lópes, R. D., Alexander, J. H., Al‐Khatib, S. M., Ansell, J., Diaz, R., Easton, J. D., Gersh, B. J., Granger, C. B., Hanna, M., Horowitz, J. D., et al. (2010) · American Heart Journal · doi:10.1016/j.ahj.2009.07.035 · Cited by 457 · see citing works
Nabauer, M., Gerth, A., Limbourg, T., Schneider, S., Oeff, M., Kirchhof, P., Goette, A., Lewalter, T., Ravens, U., Meinertz, T., et al. (2008) · Europace · doi:10.1093/europace/eun369 · Cited by 427 · see citing works
Self-citationKirchhof, P., Ammentorp, B., Darius, H., De Caterina, R., Le Heuzey, J.-Y., Schilling, R. J., Schmitt, J., & Zamorano, J. L. (2014) · EP Europace · doi:10.1093/europace/eut263 · Cited by 404 · see citing works
Ezekowitz, M. D., Connolly, S. J., Parekh, A., Reilly, P. A., Varrone, J., Wang, S., Oldgren, J., Themeles, E., Wallentin, L. C., & Yusuf, S. (2009) · American Heart Journal · doi:10.1016/j.ahj.2009.02.005 · Cited by 332 · see citing works
Chiang, C.-E., Naditch-Brûlé, L., Murin, J., Goethals, M., Inoue, H., O’Neill, J., Silva-Cardoso, J., Zharinov, O., Gamra, H., Alam, S., et al. (2012) · Circulation: Arrhythmia and Electrophysiology · doi:10.1161/circep.112.970749 · Cited by 327 · see citing works
Eikelboom, J. W., O'Donnell, M. J., Yusuf, S., Díaz, R., Flaker, G. C., Hart, R. G., Hohnloser, S. H., Joyner, C. D., Lawrence, J., Pais, P., et al. (2010) · American Heart Journal · doi:10.1016/j.ahj.2009.08.026 · Cited by 163 · see citing works
The ACTIVE Steering Committee (2006) · American Heart Journal · doi:10.1016/j.ahj.2005.06.026 · Cited by 99 · see citing works
for the ATRIUM investigators, Meinertz, T., Kirch, W., Rosin, L., Pittrow, D., Willich, S. N., & Kirchhof, P. (2011) · Clinical Research in Cardiology · doi:10.1007/s00392-011-0320-5 · Cited by 91 · see citing works
Sherman, D. G., Dyken, M. L., Fisher, M., et al. (1986) · CHEST Journal · doi:10.1378/chest.89.2_supplement.82s · Cited by 51 · see citing works
BOSCH, R. F., Kirch, W., Theuer, J.-D., Pittrow, D. B., Kohlhaußen, A., Willich, S. N., & Bonnemeier, H. (2012) · International Journal of Cardiology · doi:10.1016/j.ijcard.2012.03.053 · Cited by 16 · see citing works
Flagged first, then by citations
Cited by
Sorted by citations
2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS
Kirchhof, P., Benussi, S., Kotecha, D., Ahlsson, A., Atar, D., Casadei, B., Castella, M., Diener, H.-C., Heidbuchel, H., Hendriks, J., et al. (2016) · European Heart Journal · doi:10.1093/eurheartj/ehw210 · Cited by 6,418 · see citing works
Self-citation2021 ESC/EACTS Guidelines for the management of valvular heart disease
Vahanian, A., Beyersdorf, F., Praz, F., Milojevic, M., Baldus, S., Bauersachs, J., Capodanno, D., Conradi, L., De Bonis, M., De Paulis, R., et al. (2022) · European Heart Journal · doi:10.1093/eurheartj/ehab395 · Cited by 5,685 · see citing works
Otto, C. M., Nishimura, R. A., Bonow, R. O., Carabello, B. A., Erwin, J. P., Gentile, F., Jneid, H., Krieger, E. V., Mack, M., McLeod, C., et al. (2021) · Circulation · doi:10.1161/cir.0000000000000923 · Cited by 3,686 · see citing works
Kleindorfer, D. O., Towfighi, A., Chaturvedi, S., Cockroft, K. M., Gutierrez, J., Lombardi-Hill, D., Kamel, H., Kernan, W. N., Kittner, S. J., Leira, E. C., et al. (2021) · Stroke · doi:10.1161/str.0000000000000375 · Cited by 3,237 · see citing works
2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS
Kirchhof, P., Benussi, S., Kotecha, D., Ahlsson, A., Atar, D., Casadei, B., Castella, M., Diener, H.-C., Heidbuchel, H., Hendriks, J., et al. (2016) · European Journal of Cardio-Thoracic Surgery · doi:10.1093/ejcts/ezw313 · Cited by 1,403 · see citing works
Steffel, J., Collins, R., Antz, M., Cornu, P., Desteghe, L., Haeusler, K. G., Oldgren, J., Reinecke, H., Roldan-Schilling, V., Rowell, N., et al. (2021) · EP Europace · doi:10.1093/europace/euab065 · Cited by 1,132 · see citing works
2020 ACC/AHA guideline for the management of patients with valvular heart disease
Otto, C. M., Nishimura, R. A., Bonow, R. O., Carabello, B. A., Erwin, J. P., Gentile, F., Jneid, H., Krieger, E. V., Mack, M., McLeod, C., et al. (2021) · The Journal of Thoracic and Cardiovascular Surgery · doi:10.1016/j.jtcvs.2021.04.002 · Cited by 279 · see citing works
Drug therapy in anticoagulation: which drug for which patient?
Millar, C. M., & Laffan, M. A. (2017) · Clinical Medicine · doi:10.7861/clinmedicine.17-3-233 · Cited by 11 · see citing works
- Authors
- Breithardt, G., Baumgartner, H., Berkowitz, S. D., Hellkamp, A. S., Piccini, J. P., Stevens, S. R., Lokhnygina, Y., Patel, M. R., Halperin, J. L., Singer, D. E., Hankey, G. J., Hacke, W., Becker, R. C., Nessel, C. C., Mahaffey, K. W., Fox, K. A. A., & Califf, R. M.
- Affiliations
- University Hospital Münster (DE)
- Bayer (United States) (US)
- Duke Medical Center (US)
- Mount Sinai Hospital (US)
- Harvard University (US)
- The University of Western Australia (AU)
- Heidelberg University (DE)
- Johnson & Johnson (United States) (US)
- Stanford Medicine (US)
- Edinburgh Royal Infirmary (GB)
- Corresponding author
- Breithardt, Günter
- ORCID
- Venue
- European Heart Journal
- Publisher
- Oxford University Press (OUP)
- Published
- 2014-08-22
- Volume
- 35
- Issue
- 47
- Pages
- 3377-3385
- ISSN
- 0195-668X (ISSN-L)
- 1522-9645
- PMC
- PMC4265383
- OpenAlex
- W2113470320
- Cited by
- 196
- References
- 29
- Citations by year
- 2026: 2 · 2025: 13 · 2024: 6 · 2023: 8 · 2022: 14 · 2021: 20 · 2020: 17 · 2019: 13 · 2018: 27 · 2017: 26 · 2016: 30 · 2015: 16 · 2014: 3 · 2013: 1
- FWCI
- 17.15
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by-nc
- Locations
- European Heart Journal (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Digital Access to Scholarship at Harvard (DASH) (Harvard University) (submittedVersion, cc-by)
- UWA Profiles and Research Repository (UWA) (submittedVersion, cc-by-nc)
- Funders
- Bayer HealthCare
- Janssen Pharmaceuticals
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Valve Diseases and Treatments
- Health Sciences › Medicine › Epidemiology › Acute Ischemic Stroke Management
- Keywords
- rivaroxaban, warfarin, non-valvular atrial fibrillation, mitral valve disease, aortic valve disease, stroke prevention, bleeding risk, intracranial hemorrhage, ROCKET AF trial, direct factor Xa inhibitors, vitamin K antagonists, subgroup analysis, confounding adjustment, comorbidities
- MeSH terms
- Rivaroxaban, Aged, Anticoagulants, Aortic Valve Insufficiency, Atrial Fibrillation, Female, Hemorrhage, Humans, Male, Mitral Valve Insufficiency, Morpholines, Thiophenes, Warfarin, Treatment Outcome, Stroke, Factor Xa Inhibitors
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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 ›
Are you an author, or do you see a problem with this page? Request a review
