The aim of this study was to assess the effectiveness of MitraClip in patients with secondary mitral regurgitation (MR) who had heart failure (HF) hospitalizations or elevated BNP levels (functional classes II-IV, ejection fraction 20-50%, functional MR grade 3+/4+). Patients were randomized to receive MitraClip along with optimal medical treatment (OMT) within the first 14 days, or OMT alone, and were followed up for an average of 3.5 years.
The primary endpoint (PEP) was a composite of cardiovascular mortality and recurrent hospitalization due to heart failure (HF), hospitalization due to HF, and quality of life changes according to the Kansas Score. Secondary endpoints included changes in 6-minute walk distance, functional class (FC), and MR improvement of MR to grade ≤2.
Unlike the COAPT and MITRA-FR studies, which focused on patients with severe MR, the patients in RESHAPE-HF2 had moderate to severe secondary MR with an effective regurgitant orifice area (EROA) of 0.23 cm².
The results showed a 36% relative risk reduction in the PEP (RR 0.64; 95% confidence interval [CI] 0.48-0.85; p=0.002). The reduction in HF hospitalizations was even more significant (RR 0.59; 95% CI 0.42-0.82; p=0.002).
Additionally, the Kansas score change significantly favored the MitraClip group (difference of 10.9 points; p<0.001). MR improvement to grade ≤2 was notably superior in the MitraClip group (21.3%; 95% CI 10.7-45.8; p<0.001).
In conclusion, the authors suggest that usng MitraClip in patients with HF and moderate to severe MR could reduce HF hospitalizations and cardiovascular mortality.
Presented by Stefan D. Anker at the Hot-Line Sessions, ESC Congress 2024, August 30-September 2, London, England.
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