Skip to main content
  • EDITORIAL: 'Coapting' Clinical Evidence on Mortality Impact of MitraClip Implantation in Patients with Functional Mitral Regurgitation

    Percutaneous treatment of secondary or functional mitral regurgitation (FMR) with the MitraClip system is now performed in many countries worldwide for patients deemed at prohibitive or high surgical risk. For many years, the clinical evidence derived from observational studies has shown that MitraClip implantation for FMR is a safe procedure associated with low complication rates (intraprocedural mortality and stroke <1%), is effective in reducing regurgitation with high procedural success (>90%), improves symptoms, functional status and quality of life, and leads to reverse remodeling by reducing volume overload [[1][2][3]]. Moreover, observational studies have suggested the hypothesis that MitraClip therapy provides decreased rates of mortality and rehospitalization for heart failure compared with maximally tolerated guideline-directed medical therapy (GDMT). As those latter evidences were inconclusive, two randomized trials investigated the impact on survival and on rehospitalization of MitraClip treatment for patients with ischaemic or non-ischaemic FMR who remained symptomatic (NYHA class II–IV) despite GDMT [4,5]. The first trial was the Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation (MITRA-FR) in which the primary composite endpoint of all-cause death or re-hospitalization for heart failure at 1-year (54.6% vs. 51.3%) and its single components did not differ between patients treated with MitraClip plus maximized GDMT (n = 152) versus those managed with a stand-alone GDMT (n = 152), respectively [4]. Differently, in the second randomized Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) trial, patients assigned to MitraClip plus GDMT (n = 302) had significantly lower 2-year rates of the primary endpoint of rehospitalization (35.8% vs. 67.9% per patient-year) and of the secondary endpoint of all-cause mortality (29.1% vs. 46.1%) compared with patients assigned to GDMT alone (n = 312), respectively [5]. Due to differences in the primary endpoints and to the controversial findings of these two randomized trials, the question on whether MitraClip improves overall survival in FMR patients compared with optimal GDMT alone remains unresolved.

This site uses cookies. By continuing to browse the site you are agreeing to our use of cookies. Review our Privacy Policy for more details