Transcatheter mitral valve repair (TMVR) resulted in lower rates of hospitalization and all-cause mortality within 24 months for patients with heart failure and moderate/severe secondary mitral regurgitation (MR) who were not responding to maximum doses of guideline-recommended medical therapy alone, said researchers presenting findings from the COAPT trial at TCT 2018.

The trial, findings from which were also published in the New England Journal of Medicine, randomly assigned 614 patients from 78 sites in the U.S. and Canada to either TMVR (device group; N=302) or medical therapy alone (control group; N=312). The primary endpoint was all hospitalizations for heart failure within 24 months of follow-up. The primary safety endpoint was freedom from device-related complications at 12 months.

Overall, the primary endpoint was 35.8 percent in the device group compared with 67.9 percent per patient-year in the control group. Additionally, the rate of freedom from device-related complications at 12 months was 96.6 percent in the device group, compared with a pre-specified performance goal of 88.0 percent. Death from any cause within 24 months was observed in 29.1 percent of patients in the device group vs. 46.1 percent in the control group.

Study findings suggest "transcatheter mitral leaflet approximation with the MitraClip was safe, provided durable reduction in MR, reduced the rate of [heart failure] hospitalizations, and improved survival, quality-of-life and functional capacity during 24-month follow-up," said Gregg W. Stone, MD, FACC, who presented on behalf of the researchers. "As such, the MitraClip is the first therapy shown to improve the prognosis of patients with HF by reducing secondary MR due to LV dysfunction."

However, Stone and colleagues did highlight that longer-term follow-up is needed to "fully characterize the safety and efficacy of the device." In addition, it is unclear whether other transcatheter-based or surgical approaches could have similar results, and/or whether the MitraClip could have similar benefits in less or more critically ill patients or those with lesser degrees of MR severity.

Keywords: TCT18, Transcatheter Cardiovascular Therapeutics, Angiography, Percutaneous Coronary Intervention, Mitral Valve, Mitral Valve Insufficiency, Heart Failure

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