Abstract
Introduction
Patients with atrial fibrillation (AF) and concomitant moderate-to-severe mitral stenosis (MS) are listed as a contraindicated population to direct oral anticoagulant (DOAC) because of the traditional tenet of high stroke risk, despite scarce evidence. With accumulating data, we sought to conduct a systematic meta-analysis to preliminarily explore the efficacy and safety of DOAC versus warfarin in patients with AF and concomitant significant MS.
Methods
We searched the Medline, Embase databases, and the Cochrane Library (assessed October 10th, 2022) for eligible studies. Risk ratios (RRs) and 95% confidence intervals (CIs) were synthesized in Stata 16.1 (StataCorp).
Results
In random-effects meta-analyses, DOACs demonstrated a similar risk of stroke or systemic embolism (RR 0.51; 95% CI 0.09–2.96), all-cause death (RR 0.81; 95% CI 0.35–1.87), major or clinically relevant non-major bleeding (RR 0.57; 95% CI 0.24–1.39), and silent cerebral ischemia (RR 1.01; 95% CI 0.64–1.58) when compared with warfarin.
Conclusions
DOACs were similar to warfarin in the efficacy and safety profiles in patients with AF and concomitant significant MS. Future evidence is expected from other large trials.
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Funding
This work was supported by the National Natural Science Foundation of China (NSFC): 81970325 and 82170375; Key Research and Development Project of Science & Technology Department of Sichuan Province: 2022ZDZX0020; Key Research and Development Support Project of Science & Technology Department of Chengdu: 2021-YF08-00121-GX; Chinese Medical Association Cardiovascular Brunch (CSC) Clinical Research Special Fund Project: CSCF2020B04; and West China Hospital “1·3·5” Discipline of Excellence Project—“Percutaneous transcatheter aortic valve implantation” and “Mechanisms of aortic stenosis and the clinical applications” for Mao Chen.
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All authors contributed to the study conception and design. Material preparation, data collection, and analysis were performed by Yi Zhang. The first draft of the manuscript was written by Yi Zhang and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.
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This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of West China Hospital of Sichuan University.
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Conflict of Interest
M. Chen is consultant/proctor of Venus MedTech, MicroPort, and Peijia Medical. One another author does not have disclosures.
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Highlights
• DOACs are now guideline-recommended therapy for patients with atrial fibrillation (AF) other than EHRA type 1 (including in particular moderate–severe mitral stenosis (MS) of rheumatic origin and mechanical prosthetic valve replacement).
• In contrast to patients with AF and mechanical valve prosthesis, the guideline recommendation for DOACs in patients with AF and significant MS is not based on evidence from randomized controlled trials.
• The prevalence of rheumatic MS is low in western countries but high in low- and middle-income countries where the time in therapeutic range is poor, so the DOACs might be more effective.
• The results of this preliminary meta-analysis demonstrated similar results for the efficacy and safety of DOACs compared with warfarin in patients with AF and significant MS, calling for future validation of DOACs in this population.
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Zhang, Y., Chen, M. Direct Oral Anticoagulants in Patients with Atrial Fibrillation and Significant Mitral Stenosis—a Preliminary Meta-Analysis. Cardiovasc Drugs Ther (2023). https://doi.org/10.1007/s10557-023-07451-2
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DOI: https://doi.org/10.1007/s10557-023-07451-2