The 1-year results of the MITRA-FR trial reported in 2018 showed that the addition of percutaneous mitral valve repair to medical treatment did not improve outcomes compared with medical treatment alone in patients with heart failure and severe secondary mitral regurgitation (MR). These findings contrast with the COAPT trial results, reported shortly after, showing that mitral valve repair in addition to medical therapy improved outcomes in patients with heart failure and moderate-to-severe or severe secondary MR at 2 years. Many reasons were suggested for the different findings, including the longer follow-up in COAPT. However, the 2-year results of the MITRA-FR trial, presented at the ESC Congress 2019, confirm the 1-year findings.
The MITRA-FR trial was conducted at 37 centres in France and included 304 patients with symptomatic heart failure and severe secondary MR randomly assigned to percutaneous valve repair with a MitraClip device plus medical treatment or medical treatment alone. At 2 years, the rate of the primary efficacy outcome (all-cause death and unplanned hospitalization for heart failure) was similar in both groups (63.8% versus 67.1%; HR 1.01, 95% CI 0.77–1.34). Rates of all-cause death and hospitalization for heart failure were also similar in both groups. Interestingly, in the second year of follow-up, the MitraClip group had a lower rate of first hospitalization for heart failure. “This difference in the second year is even more visible for the cumulative number of hospitalizations, which was the primary end point of COAPT,” says the MITRA-FR investigator Jean François Obadia, who nevertheless cautions that this analysis was not prespecified and explains that they will continue the follow-up to 5 years to assess whether the decrease in rehospitalizations is sustained. “Rather than contradictory, we consider the two studies complementary, and we are now planning with the COAPT team a meta-analysis on individual data from the two trials to better understand this complex and severe disease,” he comments.
Iung, B. et al. Percutaneous repair or medical treatment for secondary mitral regurgitation: outcomes at 2 years. Eur. J. Heart Fail. https://doi.org/10.1002/ejhf.1616 (2019)
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Fernández-Ruiz, I. Still no benefit of MitraClip in MITRA-FR. Nat Rev Cardiol 16, 649 (2019). https://doi.org/10.1038/s41569-019-0280-4