Characteristics and Outcome of COAPT-Eligible Patients in the MITRA-FR Trial

heart failure ◼ heart valve diseases A lthough 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 χ 2 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 COAPTeligible 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.Of the patients included in MITRA-FR, 266 had all echocardiographic measurements available corresponding to COAPT criteria and represent the population of interest.Of them, 227 patients (85.3%) met the criteria corresponding to mitral regurgitation severity grade ≥3 according to the multiparametric algorithm of CO-APT, 3 but 38 were deemed not COAPT eligible because of left ventricular ejection fraction <20% in 11, left ventricular end-systolic diameter >70 mm in 20, and systolic pulmonary artery pressure >70 mm Hg in 7. A total of 189 patients (71.1%) were deemed COAPT eligible and 77 (28.9%) were deemed ineligible.In the 189 COAPT-eligible patients, the distribution among the 3 tiers of the multiparametric algorithm of COAPT differed significantly vs COAPT patients (P<0.0001):• Tier 1: 121 patients (64.0%versus 85.7% in the COAPT trial) had an effective regurgitant orifice area ≥0.30 cm 2 • Tier 2: 67 patients (35.5% versus 10.5% in the COAPT trial) had an effective regurgitant orifice area ≥0.20 cm 2 and <0.30 cm 2 and 1 of the following: regurgitant volume ≥45 mL/beat, regurgitant fraction ≥40%, or vena contracta ≥0.5 cm • Tier 3: 1 patient (0.5% versus 3.8% in the COAPT trial) had an effective regurgitant orifice area not measured or <20 mm 2 and at least 2 of the following: