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- Title
Reconciling conflicting evidence in the evaluation of the MitraClip system: Assessment of and response to the MITRA‐FR and COAPT trials by key stakeholders.
- Authors
Montagnon, Manuela; Chen, Yenfu; Grove, Amy; Park, Jieun; Obadia, Jean‐François; Armoiry, Xavier
- Abstract
This article discusses the conflicting results of two clinical trials, MITRA-FR and COAPT, which evaluated the effectiveness of percutaneous repair (PR) for patients with severe secondary mitral regurgitation (SMR). The MITRA-FR trial showed no benefit of PR, while the COAPT trial reported a significant improvement in clinical outcomes. The article reviews the assessment and response to these trials by key stakeholders, including regulators, health technology assessment bodies, and authors of medical journal publications. The main factors contributing to the conflicting results were differences in patient characteristics, control therapy, and procedural success rates. The majority of published documents supported the findings of the COAPT trial, but many authors called for further research and highlighted the need for standardized recommendations. The article also discusses potential explanations for the conflicting results, such as the concept of disproportionate-proportionate mitral regurgitation and the optimization of medical care prior to patient selection. The nature of sponsorship (industrial vs. academic) was also mentioned as a potential factor influencing the findings. The article concludes by emphasizing the clinical and economic impacts of discordant interpretations of clinical evidence and the importance of standardized recommendations in similar circumstances.
- Subjects
MITRAL valve insufficiency; LEGAL evidence; TRIALS (Law); HEART valve diseases; MEDICAL care; MEDICAL periodicals
- Publication
Journal of Evidence-Based Medicine, 2024, Vol 17, Issue 2, p253
- ISSN
1756-5383
- Publication type
Article
- DOI
10.1111/jebm.12614