RCT: Transcatheter Repair Noninferior to Mitral-Valve Surgery for Secondary Mitral Regurgitation

Study Design and Population: This noninferiority trial, conducted in Germany, enrolled 210 patients with heart failure and secondary mitral regurgitation who remained symptomatic despite medical therapy. Patients were randomized to undergo either transcatheter edge-to-edge repair or mitral-valve surgery, with outcomes assessed over a one-year period.

Main Findings: Transcatheter repair was found to be noninferior to mitral-valve surgery regarding the primary efficacy outcome—a composite of death, heart failure hospitalization, mitral-valve reintervention, assist device implantation, or stroke at one year (16.7% in the transcatheter group vs. 22.5% in the surgery group; mean difference, -6%; 95% CI, -17 to 6; P<0.001 for noninferiority). The transcatheter group experienced fewer major adverse events within 30 days (14.9% vs. 54.8%; mean difference, -40%; 95% CI, -51 to -27; P<0.001).

Implications for Practice: Transcatheter edge-to-edge repair offers a similar efficacy to mitral-valve surgery at one year with a lower rate of short-term adverse events, suggesting it may be a suitable alternative, particularly for patients with higher surgical risk.

Reference: Baldus, S. et al. (2024). Transcatheter repair versus mitral-valve surgery for secondary mitral regurgitation. New England Journal of Medicine. DOI: http://doi.org/10.1056/NEJMoa2408739