Percutaneous mitral valve repair by MitraClip: critical-comparative analysis of MITRA-FR and COAPT clinical trials
DOI:
https://doi.org/10.11606/issn.1679-9836.v101i1e-190085Keywords:
Mitral Regurgitation, Minimally Invasive Surgical Procedures, Clinical TrialAbstract
Introduction: Valvuloplasty is indicated as treatment for severe mitral regurgitation and the transcatheter technique is an option to thoracotomy. The MitraClip device for percutaneous mitral valve repair has been tested in two randomized clinical trials with conflicting results: MITRA-FR and COAPT. Objective: Analyze the methodological varieties presented by the trials. Method: Critical-comparative review between MITRA-FR and COAPT. Results: COAPT presented a 98% success rate and a reduction of the hospitalization rate for heart failure. Contrarily, the MITRA-FR trial did not present any benefits in the reduction of the mortality rate or in the unplanned hospitalization for heart failure. Discussion: The selection of participants in COAPT was more rigorous. Although COAPT used a higher number of clips per operation, the primary outcome in both trials was similar. In COAPT, medication follow-up was established by a committee, with a significant increase in the use of beta-blockers in the experimental group being reported. Furthermore, financial interests may have corroborated the results found in COAPT. Conclusion: The conflicting results presented by MITRA-FR and COAPT are explained by methodological differences, but the positive result presented by COAPT had more risk of bias.
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Copyright (c) 2022 Bárbara Machado Garcia, Beatriz Libero Abdalla, Bruna Eduarda Ribeiro Ramos, Carolina Carvalho Tolentino, Caroline Miranda Rocha, Eduardo Augusto Victor Rocha
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