Baseline echocardiographic characteristics of patients enrolled in the randomized investigation of MitraClip device in heart failure (RESHAPE HF-2) trial: comparison with COAPT and Mitra-FR

Abstract

Background: The RESHAPE-HF2 trial is aimed at evaluating the efficacy of the MitraClip device for the treatment of clinically significant functional mitral regurgitation (FMR) in patients with heart failure (HF). This report describes the baseline echocardiographic characteristics of patients enrolled in the RESHAPE-HF2 trial compared to those enrolled in the COAPT and MITRA-FR trials. Methods: The RESHAPE-HF2 study is a prospective, randomized, multicenter trial involving patients with symptomatic HF, a left ventricular ejection fraction (LVEF) between 20% and 50%, and moderate-to-severe or severe FMR who are ineligible for isolated mitral valve surgery, despite receiving guideline-directed therapy. Patients were randomized 1:1 to either receive the MitraClip or be placed in a control group without the intervention. Results: For the 505 patients randomized (mean age 70 years, 20% female, mean body mass index 26.8 kg/m2), the mean LVEF in the cohort was 31±8%. The mean regurgitant volume was 37±12 mL, while mean proximal iso-velocity surface area (PISA) radius was 0.72 cm. Less than half of the patients (44%) had MR severity grade 4+. The mean effective regurgitant orifice area (EROA) among patients in RESHAPE-HF2 (0.25 cm2) was lower compared to patients in MITRA-FR (0.31 cm2) and in COAPT (0.40 cm2) trials. Regurgitant volumes in RESHAPE-HF2 were 18% lower than in than in MITRA-FR (45 mL) but 38% higher than in COAPT (27 mL). The mean LV end-diastolic volumes values in the RESHAPE-HF2, COAPT, and MITRA-FR trials were 211 mL, 193 mL, and 250 mL, respectively. Patients in RESHAPE-HF2 (41 mmHg) had a comparatively lower right ventricular systolic pressure than patients in MITRA-FR (54 mmHg) and in COAPT (44 mmHg). Patients in RESHAPE-HF2, MITRA-FR, and COAPT had a similar LVEF of around 31%. Conclusions: The baseline echocardiographic characteristics of patients in the RESHAPE-HF2 trial differ from patients in the MITRA-FR and COAPT trials. Patients enrolled in RESHAPE-HF2 had moderate-to-severe FMR, characterized by a smaller PISA radius, a lesser proportion of MR severity grade of 4+, and lower mean EROA and regurgitant volumes compared to patients in COAPT and MITRA-FR trials. LVEF was largely similar across all trials. RESHAPE-HF2 is testing TEER in a third distinct cohort of patients who have less severe FMR compared to patients in COAPT trial but have high left atrial volumes. The RESHAPE-HF2 population is also echocardiographically different from the MITRA-FR cohort.