Key result
M-TEER trends toward fewer CV events and improves KCCQ scores vs medical therapy across baseline tertiles.
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?
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?
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.
Supports M-TEER across baseline health status in HF with SMR; extends prior RCTs by confirming consistent trends and KCCQ gains.
BACKGROUND AND AIMS: Mitral transcatheter edge-to-edge repair (M-TEER) using the MitraClip device improves clinical outcomes in patients with moderate-to-severe ventricular secondary mitral regurgitation (vSMR) and heart failure (HF). This study evaluated whether the effects of M-TEER on clinical outcomes vary by baseline health status, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ), and assessed the impact of M-TEER on health status post-randomization. METHODS: The RESHAPE-HF2 trial included patients with symptomatic HF and moderate-to-severe vSMR (mean effective regurgitant orifice area .25 cm2; 14% >.40 cm2, 23% <.20 cm2). The impact of baseline KCCQ-clinical summary score (CSS) on the effect of M-TEER on clinical outcomes was assessed using Cox proportional hazards models. Changes post-randomization in health status and responder analyses were performed to assess the odds ratio (OR) of improvement and deterioration in KCCQ scores. RESULTS: Among 505 patients, M-TEER reduced cardiovascular death or HF hospitalization risk [hazard ratio (HR): .71 (.48-1.05), .50 (.29-.85), and .73 (.38-1.41)] across KCCQ-CSS tertiles of <38.9, 38.9-66.1, and >66.1, respectively (P-trend = .53). Similar results were seen for total HF hospitalization (P-trend = .48). M-TEER improved KCCQ-CSS, total symptom score, and overall summary score at 1, 6, 12, and 24 months compared to medical therapy alone (P < .05 at all time points). More patients in the M-TEER arm experienced a ≥5-point [OR 3.38 (2.09-5.45)], ≥10-point [OR 3.12 (1.93-5.02)], and ≥15-point [OR 3.25 (1.94-5.45)] improvement, and less patients had a ≥5-point deterioration [OR .34 (.19-.57)] in KCCQ-CSS at 6 months. Similar results were seen across other KCCQ domains and all time points. CONCLUSIONS: In patients with HF and moderate-to-severe vSMR, M-TEER showed a consistent trend towards a lower risk of HF hospitalization, with or without cardiovascular death, across all KCCQ-CSS tertiles and improved health status over time.
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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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