Key result
Transcatheter correction using the Mitraclip system showed no benefit for death or heart failure hospitalization at 24 months across any subset of mitral regurgitation severity or LV remodeling.
Why the study?
Differences in the degree of mitral regurgitation and left ventricular remodeling were suggested to explain conflicting results between the MITRA-FR and COAPT trials.
Does transcatheter correction using the Mitraclip system reduce the composite of death from any cause or unplanned hospitalization for heart failure in specific echocardiographic subsets of patients with severe functional/secondary mitral regurgitation?
RCT
Yes
Does transcatheter correction using the Mitraclip system reduce the composite of death from any cause or unplanned hospitalization for heart failure in specific echocardiographic subsets of patients with severe functional/secondary mitral regurgitation?
This post hoc analysis of the MITRA-FR trial found no echocardiographic subset of patients with severe secondary mitral regurgitation, including those with disproportionate MR, that benefited from MitraClip implantation.
OBJECTIVES This study aimed to identify a subset of patients based on echocardiographic parameters who might have benefited from transcatheter correction using the Mitraclip system in the MITRA-FR (Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation) trial. BACKGROUND It has been suggested that differences in the degree of mitral regurgitation (MR) and left ventricular (LV) remodeling may explain the conflicting results between the MITRA-FR and the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trials. METHODS In a post hoc analysis, we evaluated the interaction between the intervention and subsets of patients defined based on MR severity (effective regurgitant orifice [ERO], regurgitant volume [RVOL] and regurgitant fraction [RF]), LV remodeling (end-diastolic and end-systolic diameters and volumes) and combination of these parameters with respect to the composite of death from any cause or unplanned hospitalization for heart failure at 24 months. RESULTS We observed a neutral impact of the intervention in subsets with the highest MR degree (ERO ≥30 mm2, RVOL ≥45 ml or RF ≥50%) as in patients with milder MR degree. The same was seen in subsets with the milder LV remodeling using either diastolic or systolic diameters or volumes. When parameters of MR severity and LV remodeling were combined, there was still no benefit of the intervention including in the subset of patients with an ERO/end-diastolic volume ratio ≥ 0.15 despite similar ERO and LV end-diastolic volume compared with COAPT patients. CONCLUSIONS In the MITRA-FR trial, we could not identify a subset of patients defined based on the degree of the regurgitation, LV remodeling or on their combination, including those deemed as having disproportionate MR, that might have benefited from transcatheter correction using the Mitraclip system. (Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation [MITRA-FR]; NCT01920698).
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Messika–Zeitoun et al. (2020) conducted an RCT in Severe Functional/Secondary Mitral Regurgitation. Mitraclip system was evaluated on Composite of death from any cause or unplanned hospitalization for heart failure at 24 months. Transcatheter correction using the Mitraclip system showed no benefit for death or heart failure hospitalization at 24 months across any subset of mitral regurgitation severity or LV remodeling.
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