Why the study?
It was unknown whether the effects of M-TEER on clinical outcomes vary by baseline health status as measured by the KCCQ, and what impact M-TEER has on post-randomization health status.
Does mitral transcatheter edge-to-edge repair improve clinical outcomes and health status compared to medical therapy alone in patients with symptomatic heart failure and moderate-to-severe ventricular secondary mitral regurgitation across different baseline health status levels?
Population
505 patients with symptomatic HF and moderate-to-severe vSMR
Comparison
M-TEER vs medical therapy alone
Design
Randomized controlled trial (RESHAPE-HF2 trial)
Follow-up
24 months
Key result
M-TEER showed a consistent trend towards lower risk of CV death or HF hospitalization across baseline health status tertiles (HRs 0.71, 0.50, 0.73; P-trend=0.53) and improved KCCQ scores.
Authors
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Supports M-TEER across baseline health status in HF with SMR; extends prior RCTs by confirming consistent trends and KCCQ gains.
RCT (n=505)
Does mitral transcatheter edge-to-edge repair improve clinical outcomes and health status compared to medical therapy alone in patients with symptomatic heart failure and moderate-to-severe ventricular secondary mitral regurgitation across different baseline health status levels?
Effect estimate: HR 0.71, 0.50, and 0.73 (95% CI 0.48-1.05, 0.29-0.85, 0.38-1.41)
p-value: p=0.53
M-TEER improves health status and consistently reduces the risk of heart failure hospitalization or cardiovascular death regardless of baseline health status in patients with heart failure and moderate-to-severe secondary mitral regurgitation.
Butler et al. (2025) conducted an RCT in Heart failure and moderate-to-severe ventricular secondary mitral regurgitation (n=505). Mitral transcatheter edge-to-edge repair (M-TEER) vs. Medical therapy alone was evaluated on Cardiovascular death or heart failure hospitalization (HR 0.71, 0.50, and 0.73, 95% CI 0.48-1.05, 0.29-0.85, 0.38-1.41, p=0.53). M-TEER showed a consistent trend towards lower risk of CV death or HF hospitalization across baseline health status tertiles (HRs 0.71, 0.50, 0.73; P-trend=0.53) and improved KCCQ scores.
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