This study states that Although addressing the same issue, the MITRA-FR trial (Percutaneous Repair With the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation) and the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) led to divergent results.1,2 Differences in patient characteristics may account for these discrepancies but have not been specifically studied. We aimed to identify a subgroup of patients from MITRA-FR matching inclusion criteria of COAPT to assess their characteristics and clinical outcome compared with patients who did not match COAPT inclusion criteria and evaluate the efficacy of transcatheter mitral valve repair (TMVr) in COAPT-eligible and -ineligible patients. We defined COAPT-eligible patients according to COAPT echocardiographic inclusion criteria.2,3 The efficacy end point was the composite of all-cause death or unplanned hospitalization for heart failure at 24 months.4 Comparisons used the unpaired t test for continuous variables and the χ2 of Fisher exact test. A Cox proportional hazard regression model stratified on center was used to compare the composite efficacy end point between COAPT-eligible and ineligible patients and a Cox model with interaction was used to estimate the treatment effect in COAPT-eligible and -ineligible patients. The trial was approved by the French centralized ethics committee and the French National Agency for the Safety of Medicines and Health Products. All patients gave informed consent. The data, methods, and study materials are available on reasonable request
Reference link- https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.120.049743
