Transcatheter mitral leaflet approximation with the MitraClip proved safe and had better outcomes at three years in heart failure (HF) patients with moderate or severe secondary mitral regurgitation (MR), compared with maximally-tolerated guideline-directed medical therapy (GDMT), based on new data from the COAPT trial presented Sept. 28 at TCT 2019.

Michael J. Mack, MD, FACC, and colleagues sought to describe the three-year clinical outcomes of patients enrolled in the COAPT trial, including those who crossed over to MitraClip. They also specifically analyzed the impact of MitraClip crossovers in patients assigned to GDMT alone (n=58/312; 18.6 percent). Per trial protocol, patients randomized to GDMT were not allowed to crossover to the MitraClip prior to 24 months; but were permitted to do so after that point.

Results found that at 36 months transcatheter mitral leaflet approximation with the MitraClip was safe, provided durable reduction in MR, reduced the rate of HF hospitalizations, and improved survival, quality of life and functional capacity compared with GDMT. In patients assigned to only GDMT who crossed-over and received a MitraClip, fewer HF hospitalizations and deaths or HF rehospitalizations within 12 months were observed, compared with patients who did not crossover. Mack noted that rates were comparable to patients originally assigned to the MitraClip.

Meanwhile, in a separate COAPT study published in the Journal of the American College of Cardiology, Federico M. Asch, MD, FACC, and colleagues implemented a novel echocardiographic algorithm for grading MR severity during the screening process. Results found patients in the COAPT trial selected using strict echocardiographic criteria, benefitted from transcatheter mitral valve repair with reduced two-year rates of death and HF hospitalization. "Strict application of these echocardiographic criteria should enable the COAPT results to be translated to clinical practice," said Asch, et al.

Keywords: TCT19, Transcatheter Cardiovascular Therapeutics, Angiography, Percutaneous Coronary Intervention, Mitral Valve Insufficiency, Heart Failure

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