TEER plus optimal medical therapy versus medical therapy alone in functional mitral regurgitation

Mitral regurgitation (MR) is a highly prevalent valvular heart disease that, in advanced stages and when left untreated, is associated with reduced quality of life, heart failure, and increased mortality. In recent years, transcatheter edge-to-edge repair (TEER) has become an established, minimally invasive interventional strategy for patients with symptomatic moderate-to-severe functional mitral regurgitation (FMR) who are not suitable candidates for surgery due to high surgical risk.

Despite its growing use, the predictability of outcomes and the sustained long-term effectiveness in reducing major adverse cardiovascular events remain uncertain. This variability in outcomes has largely been attributed to differences in patient selection criteria, including left ventricular volume and systolic function, the mechanism and severity of mitral regurgitation, the stage of heart failure, and the presence of comorbidities.

Study Characteristics

The objective of this meta-analysis was to compare long-term clinical outcomes between TEER plus optimal medical therapy (OMT) and OMT alone in patients with symptomatic moderate-to-severe FMR.

The primary endpoint (PE) was the composite of death or hospitalization for heart failure (HF) at 24 months. The secondary endpoint (SE) was first hospitalization for HF at 24 months.

Three randomized controlled trials were included (MITRA-FR, COAPT, and RESHAPE-HF2), comprising a total of 1,422 patients assigned to TEER plus OMT (n = 703) or OMT alone (n = 719). The PE was significantly lower in the TEER plus OMT group compared with the OMT-alone group in the one-stage analysis (HR 0.72; 95% CI: 0.56–0.92; p = 0.010). However, the two-stage analysis did not confirm this finding (HR 0.72; 95% CI: 0.51–1.00; p = 0.052) and demonstrated substantial heterogeneity (I² = 80.3%; p = 0.006).

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Hospitalization for heart failure was significantly reduced in the TEER plus OMT group regardless of the statistical approach 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). All-cause mortality and cardiovascular mortality at 24 months did not differ significantly between treatment groups but became significant after exclusion of the MITRA-FR trial in the sensitivity analysis.

Conclusion: TEER plus optimal medical therapy reduces mortality and heart failure hospitalizations in functional mitral regurgitation

In patients with FMR, TEER in addition to OMT was associated with a significant reduction in the composite of mortality or heart failure hospitalization compared with OMT alone. However, the high heterogeneity observed among trials resulted in non-significant intergroup differences when more conservative statistical methods were applied.

Although a favorable numerical trend was observed for TEER plus OMT, all-cause and cardiovascular mortality did not differ significantly between treatment strategies. Exclusion of the MITRA-FR trial was critical to demonstrate improved survival in the TEER plus OMT group. Further research is required to clarify whether these findings reflect differences in patient selection.

Original Title: 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.

Reference: Nicola Ammirabile et al EuroIntervention 2026;22:e101-e112.