MUNICH — In patients with HF with reduced ejection fraction and secondary mitral valve regurgitation, percutaneous mitral valve repair plus medical therapy offered no advantage over medical therapy alone, according to the MITRA-FR trial.
Jean-Francois Obadia, MD, PhD, from Hopital Cardiovasculaire Louis Pradel, Lyon, France, said during a presentation at the European Society of Cardiology Congress that secondary mitral valve regurgitation often portends poor prognosis in patients with HFrEF, so the MITRA-FR trial was launched to see whether percutaneous mitral valve repair with the MitraClip device (Abbott Vascular) would lead to improved outcomes.
“We don’t know if the regurgitation is a consequence or cause of disease or just a marker, but what we know for sure is that it is directly correlated to the prognosis,” Obadia said at a press conference. “The more severe the regurgitation, the poorer the prognosis. As a consequence, it has been proposed to treat this regurgitation by surgery … or by a new technique with a clip. But we did not know if the correction of the regurgitation modifies the prognosis.”
He noted that evidence for treatment with medical therapy is weak and has just a Class IIb recommendation in the guidelines.
Obadia and colleagues randomly assigned 304 patients with severe secondary mitral regurgitation, defined as effective regurgitant orifice area > 20 mm2 or regurgitant volume > 30 ml per beat, and HF with EF between 15% and 40% to receive percutaneous mitral valve repair plus medical therapy (mean age, 70 years; 79% men) or medical therapy alone (mean age, 71 years; 70% men).
The primary outcome was all-cause mortality or unplanned HF hospitalization at 12 months. The results were simultaneously published in The New England Journal of Medicine.
According to the researchers, the primary outcome occurred in 54.6% of the intervention group and 51.3% of the control group (OR = 1.16; 95% CI, 0.73-1.84).
All-cause mortality did not differ between the groups (intervention, 24.3%; control, 22.4%; HR = 1.11; 95% CI, 0.69-1.77), nor did unplanned HF hospitalization (intervention, 48.7%; control, 47.4%; HR = 1.13; 95% CI, 0.81-1.56), Obadia said.
The percutaneous mitral valve repair procedure was safe with few complications and there were no conversions to open surgery, he said. In the intervention group, 96% of patients had decreased mitral regurgitation after the procedure, he noted.
“This is the first randomized trial in this area, and we answered two questions,” Obadia said during the press conference. “Is the procedure safe and efficient? The answer is yes. The device did its job to decrease regurgitation. Does it improve the clinical outcomes? For this part of the question, the answer is no. The main cause of the disease is the underlying cardiomyopathy, and the regurgitation is probably just a signal or marker of the disease, but not the real cause of the prognosis of the patient. It is also important to consider that this conclusion should be applied to a population of patients corresponding to our inclusion criteria. Therefore, we cannot exclude a positive answer in a subgroup of patients with better ventricular function treated at an earlier stage of the disease.”
In a discussant presentation, Stephan Windecker, MD, physician-in-chief and director of invasive cardiology at the department of cardiology, Swiss Cardiovascular Center Bern, Switzerland, said that use of the MitraClip in this population as palliative care may be considered in patients who are severely symptomatic and with contractile reserve. – by Erik Swain
Obadia J-F, et al. Hot Line Session 3. Presented at: European Society of Cardiology Congress; Aug. 25-29, 2018; Munich.
Obadia J-F, et al. N Engl J Med. 2018;doi:10.1056/NEJMoa1805374.
Disclosure: The study was funded mainly by the French Ministry of Health and in part by Abbott Vascular. Obadia reports he received grants from Abbott and Neochord and personal fees from Delacroix-Chevalier, Edwards Lifesciences, Landanger, Medtronic, Novartis and Servier. Please see the study for a list of the other authors’ relevant financial disclosures.