The DOI matches its Crossref record; 7 of the 7 references it cites were found in a registry or an index.
Dabigatran Association With Higher Risk of Acute Coronary Events: Meta-analysis of Noninferiority Randomized Controlled Trials
Abstract
BACKGROUND: The original RE-LY (Randomized Evaluation of Long-term Anticoagulant Therapy) trial suggested a small increased risk of myocardial infarction (MI) with the use of dabigatran etexilate vs warfarin in patients with atrial fibrillation. We systematically evaluated the risk of MI or acute coronary syndrome (ACS) with the use of dabigatran. METHODS: We searched PubMed, Scopus, and the Web of Science for randomized controlled trials of dabigatran that reported on MI or ACS as secondary outcomes. The fixed-effects Mantel-Haenszel (M-H) test was used to evaluate the effect of dabigatran on MI or ACS. We expressed the associations as odds ratios (ORs) and their 95% CIs. RESULTS: Seven trials were selected (N = 30,514), including 2 studies of stroke prophylaxis in atrial fibrillation, 1 in acute venous thromboembolism, 1 in ACS, and 3 of short-term prophylaxis of deep venous thrombosis. Control arms included warfarin, enoxaparin, or placebo administration. Dabigatran was significantly associated with a higher risk of MI or ACS than that seen with agents used in the control group (dabigatran, 237 of 20,000 [1.19%] vs control, 83 of 10,514 [0.79%]; OR(M-H), 1.33; 95% CI, 1.03-1.71; P = .03). The risk of MI or ACS was similar when using revised RE-LY trial results (OR(M-H), 1.27; 95% CI, 1.00-1.61; P = .05) or after exclusion of short-term trials (OR(M-H), 1.33; 95% CI, 1.03-1.72; P = .03). Risks were not heterogeneous for all analyses (I(2) = 0%; P ≥ .30) and were consistent using different methods and measures of association. CONCLUSIONS: Dabigatran is associated with an increased risk of MI or ACS in a broad spectrum of patients when tested against different controls. Clinicians should consider the potential of these serious harmful cardiovascular effects with use of dabigatran.
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Cites
Quantifying heterogeneity in a meta‐analysis
Higgins, J. P. T., & Thompson, S. G. (2002) · Statistics in Medicine · doi:10.1002/sim.1186 · Cited by 36,763
Assessing the quality of reports of randomized clinical trials: Is blinding necessary?
Jadad, A. R., Moore, R. A., Carroll, D., Jenkinson, C., Reynolds, D. J. M., Gavaghan, D. J., & McQuay, H. J. (1996) · Controlled Clinical Trials · doi:10.1016/0197-2456(95)00134-4 · Cited by 17,582
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
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
Apixaban 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
Apixaban 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
Newly identified events in the RE-LY trial
Connolly, S. J., Ezekowitz, M. D., Yusuf, S., Reilly, P. A., & Wallentin, L. (2010) · New England Journal of Medicine · doi:10.1056/nejmc1007378 · Cited by 688
Cited by
2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation
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) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2014.03.022 · Cited by 2,955
Meschia, J. F., Bushnell, C., Boden-Albala, B., Braun, L. T., Bravata, D. M., Chaturvedi, S., Creager, M. A., Eckel, R. H., Elkind, M. S. V., Fornage, M., et al. (2014) · Stroke · doi:10.1161/str.0000000000000046 · Cited by 2,650
Extended Use of Dabigatran, Warfarin, or Placebo in Venous Thromboembolism
Schulman, S., Kearon, C., Kakkar, A. K., Schellong, S., Eriksson, H., Baanstra, D., Kvamme, A. M., Friedman, J., Mismetti, P., & Goldhaber, S. Z. (2013) · New England Journal of Medicine · doi:10.1056/nejmoa1113697 · Cited by 983
Heidbuchel, H., Verhamme, P., Alings, M., Antz, M., Hacke, W., Oldgren, J., Sinnaeve, P., Camm, A. J., & Kirchhof, P. (2013) · Europace · doi:10.1093/europace/eut083 · Cited by 792
National trends in ambulatory oral anticoagulant use
Barnes, G. D., Lucas, E., Alexander, G. C., & Goldberger, Z. D. (2015) · The American Journal of Medicine · doi:10.1016/j.amjmed.2015.05.044 · Cited by 598
Metadata
- Authors
- Uchino, K.
- Venue
- Archives of Internal Medicine
- Publisher
- American Medical Association (AMA)
- Published
- 2012-03-12
- Volume
- 172
- Issue
- 5
- Pages
- 397
- ISSN
- 0003-9926 (ISSN-L)
- OpenAlex
- W2161876144
- Cited by
- 431
- References
- 7
- FWCI
- 65.61
- Type
- journal article
- Language
- en
- Open access
- closed
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