Percutaneous repair with the MitraClip device yielded a 39.8% rate of freedom from death, surgery, or severe MR at 4 years compared to 53.4% with conventional surgery (p=0.070).
RCT (n=279)
2:1 ratio
Absolute Event Rate: 39.8% vs 53.4%
p-value: p=0.070
OBJECTIVES: This study sought to evaluate 4-year outcomes of percutaneous repair versus surgery for mitral regurgitation. BACKGROUND: Transcatheter therapies are being developed to treat valvular heart disease. In the EVEREST (Endovascular Valve Edge-to-Edge Repair Study) II trial, treatment of mitral valve regurgitation (MR) with a novel percutaneous device was compared with surgery and showed superior safety, but less reduction in MR at 1 year overall. We report the 4-year outcomes from the EVEREST II trial. METHODS: Patients with grade 3+ or 4+ MR were randomly assigned to percutaneous repair with the MitraClip (Abbott, Menlo Park, California) device or conventional mitral valve surgery in a 2:1 ratio (184:95). Patients prospectively consented to 5 years of follow-up. RESULTS: At 4 years, the rate of the composite endpoint of freedom from death, surgery, or 3+ or 4+ MR in the intention-to-treat population was 39.8% versus 53.4% in the percutaneous repair group and surgical groups, respectively (p = 0.070). Rates of death were 17.4% versus 17.8% (p = 0.914), and 3+ or 4+ MR was present in 21.7% versus 24.7% (p = 0.745) at 4 years of follow-up, respectively. Surgery for mitral valve dysfunction, however, occurred in 20.4% versus 2.2% (p < 0.001) at 1 year and 24.8% versus 5.5% (p < 0.001) at 4 years. CONCLUSIONS: Patients treated with percutaneous repair of the mitral valve more commonly required surgery to treat residual MR; however, after the first year of follow-up, there were few surgeries required after either percutaneous or surgical treatment and no difference in the prevalence of moderate-severe and severe MR or mortality at 4 years. (Endovascular Valve Edge-to-Edge Repair Study EVEREST II; NCT00209274).
Mauri et al. (2013) conducted an RCT in grade 3+ or 4+ mitral regurgitation (n=279). Percutaneous repair with the MitraClip device vs. Conventional mitral valve surgery was evaluated on Composite endpoint of freedom from death, surgery, or 3+ or 4+ MR (p=0.070). Percutaneous repair with the MitraClip device yielded a 39.8% rate of freedom from death, surgery, or severe MR at 4 years compared to 53.4% with conventional surgery (p=0.070).