Abstract
Abstract Background The COAPT randomized trial has shown a huge benefit in the survival of patients with heart failure and functional mitral regurgitation treated with Mitraclip. However, patients in COAPT trial were highly selected and the clinical course in real-world patients with and without fulfilment of the trial inclusion criteria is unclear. Methods and Results The present study examined the clinical outcome in consecutive patients (n=146) with symptomatic moderate-to-severe or severe MR of dominant functional etiology undergoing Mitraclip therapy by the presence of the inclusion criteria of the COAPT trial (left ventricular ejection fraction >20%, left ventricular end-systolic dimension <70 mm, non-commissural primary jet, estimated pulmonary artery systolic pressure <70 mmHg, mitral valve orifice area >4 cm2, no prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve or any prior transcatheter mitral valve procedure). The primary endpoint was the composite of all-cause mortality or heart failure hospitalization. Secondary endpoints were the single components of the primary endpoint (heart failure hospitalization, all-cause mortality) and cardiovascular mortality. Among 146 patients who underwent Mitraclip implantation 35.6% fulfilled the inclusion criteria of COAPT. The composite endpoint was significantly less frequent in patients fulfilling the COAPT selection criteria than in those not fulfilling the criteria [HR 0.3851 (0.2266 to 0.6642); p=0.0017] (Figure). Conclusion In this single center study the outcome of patients with functional mitral regurgitation undergoing Mitraclip therapy was significantly worse in patients not fulfilling COAPT inclusion criteria, indicating that these criteria might help identify futility.
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