Transcatheter edge-to-edge repair plus guideline-directed medical therapy versus guideline-directed medical therapy alone for symptomatic functional mitral regurgitation: a comprehensive, up-to-date meta-analysis of randomised trials

Abstract

Background: Transcatheter edge-to-edge repair (TEER) is among the treatments for functional mitral regurgitation (FMR), but its benefits over guideline-directed medical therapy (GDMT) alone are discordant. We conducted a meta-analysis of randomised trials comparing long-term outcomes between these treatment strategies.

Aims: We aimed to compare long-term clinical outcomes between TEER plus GDMT and GDMT alone in symptomatic moderate-to-severe FMR.

Methods: Major electronic databases were searched for randomised trials comparing TEER plus GDMT with GDMT alone in FMR. The primary outcome was death or first hospitalisation due to heart failure at 24 months. The key secondary outcome was first hospitalisation due to heart failure at 24 months. Summary hazard ratios (HRs) with 95% confidence intervals (CIs) were computed by mixed-effects Cox models based on reconstructed time-to-first event individual patient data and random-effects models based on study-level data.

Results: Three randomised trials (MITRA-FR, COAPT, and RESHAPE-HF2) were included, for a total of 1,422 patients assigned to TEER plus GDMT (n=703) or GDMT alone (n=719). The primary outcome was significantly lower in the TEER plus GDMT group compared with the GDMT-alone group by one-stage analysis (HR 0.72, 95% CI: 0.56-0.92; p=0.010). However, the two-stage analysis marginally failed to confirm this result (HR 0.72, 95% CI: 0.51-1.00; p=0.052) and showed substantial heterogeneity (I²=80.3%; p=0.006). Hospitalisation due to heart failure was significantly lower in the TEER plus GDMT group, regardless of the statistical method used (one-stage: HR 0.65, 95% CI: 0.48-0.88; p=0.006; two-stage: HR 0.66, 95% CI: 0.45-0.96; p=0.031). However, heterogeneity was substantial (I²=81.2%; p=0.005). All-cause death and cardiovascular death at 24 months were not significantly different between treatment groups but became significant after excluding MITRA-FR in the leave-one-out analysis.

Conclusions: In symptomatic moderate-to-severe FMR, TEER plus GDMT significantly reduces death or hospitalisation due to heart failure and hospitalisation due to heart failure at 24 months.