Percutaneous Transcatheter Edge-to-Edge Repair for Functional Mitral Regurgitation in Heart Failure: A Meta-Analysis of Three RCTs

In this meta-analysis, the authors included three randomized controlled trials (RCTs) conducted in patients with heart failure (HF) and moderate to severe functional mitral regurgitation (FMR), comparing treatment with the MitraClip device in addition to medical therapy (device arm) to medical therapy alone (control arm). The following trials were included: COAPT, MITRA-FR, and RESHAPE-HF2. For this meta-analysis, the authors used common endpoints that were reported in each trial, namely, the first publication of COAPT, MITRA-FR, and RESHAPE-HF2, the extended two-year follow-up report of MITRA-FR, and one additional paper on RESHAPE-HF2. 
 
The meta-analysis showed no statistically significant difference in all-cause mortality within 24 months (HR: 0.76 [95 percent CI: 0.57-1.01]; P = 0.056) and cardiovascular mortality within 24 months (HR: 0.77 [95 percent CI: 0.56-1.06]; P = 0.112). However, the models showed better outcomes for the device group compared with the control group regarding total unplanned HF hospitalizations within 24 months (HR: 0.69 [95 percent CI: 0.49-0.97]; P = 0.0324), a composite of recurrent events of hospitalization for HF or all-cause mortality within 24 months (HR: 0.71 [95 percent CI: 0.50-0.995]; P = 0.0486), and change in six-minute walk distance from baseline to 12 months (mean change in meters: 32.55 [95 percent CI: 2.68-62.43]; P = 0.0327). 
 
In summary, this meta-analysis, including the three largest RCTs on this topic, suggests benefits for HF hospitalizations and improvement in six-minute walk distance after M-TEER with the MitraClip device in addition to medical therapy, compared with medical therapy alone, in patients with symptomatic HF and moderate to severe FMR. However, there was no significant benefit in cardiovascular or all-cause mortality.