New COAPT Results Show Benefits of TMVR in Heart Failure With Mitral Regurgitation
Echocardiography is effective when used for patient selection for transcatheter mitral valve repair (TMVR) and TMVR improves health status in patients with heart failure (HF) and secondary mitral regurgitation (MR), according to results of two new substudies of the COAPT trial presented at ACC.19 in New Orleans.
The COAPT trial compared clinical events and health status in 614 patients with HF and secondary MR randomized to TMVR with the MitraClip vs. standard care. At two years, survival was significantly better among patients in the TMVR group. In the first analysis, Federico M. Asch, MD, FACC, et al., evaluated valve function and patient suitability for TMVR with echocardiography before enrollment and at one, six, 12, 18 and 24 months, using an algorithm developed by expert echocardiographers.
The results showed that TMVR was effective for preventing MR and the effect persisted throughout the two-year follow-up. Patients in all subgroups benefitted from TMVR, with respect to size, function or pressures of the cardiac chambers. "MitraClip was shown to be beneficial in the study population in all subgroups analyzed, regardless of patients' echocardiographic characteristics," Asch said. "Doing an echocardiogram is critical in determining if a patient is a good candidate for MitraClip and in following these patients to evaluate results of the procedure in the long run."
A health status substudy, presented by Suzanne Arnold, MD, et al., evaluated health status, including quality of life (QoL), with the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the Medical Outcomes Study Short-Form 36 (SF-36) physical (PCS) and mental (MCS) Health Survey at one, six, 12 and 24 months from baseline. The mean KCCQ overall score (OS) score at baseline was 52.4, with a QoL score of 44.9. The results were simultaneously published in the Journal of the American College of Cardiology.
At one month, the KCCQ-OS, the SF-36 PCS and SF-36 MCS increased significantly by 16.9 points, 6.0 points and 4.2 points, respectively, in the TMVR group. In the TMVR group, all KCCQ domains improved significantly by one month, with the greatest improvement observed for QoL (23.2 points). Among patients receiving standard therapy, the KCCQ-OS increased by 2.1 points with small but significant changes at later time points and no significant changes in the SF-36 PCS or MCS scores.
The KCCQ-OS increase was significantly greater with TMVR than with standard therapy at one, 12 and 24 months (p<0.001 for all time points), demonstrating only slight attenuation of treatment effect over time. Similar results were observed for the SF-36 PCS and MCS. The health status benefit of TMVR vs. standard therapy was consistent across all subgroups, except for patients with ischemic cardiomyopathy, who derived greater health status benefit than those with nonischemic cardiomyopathy. At 24 months, 39.3 percent of patients in the TMVR group were alive compared with 20.8 percent in the standard therapy group.
"In patients with heart failure and secondary mitral regurgitation, TMVR resulted in early, substantial and sustained improvement in health status compared with standard care," Arnold said. "Showing that TMVR improves patients' symptoms and quality of life adds further support to the use of TMVR in these patients."
Keywords: ACC19, ACC Annual Scientific Session, Mitral Valve Insufficiency, Heart Failure, Echocardiography, Heart Valve Diseases, Mitral Valve, Quality of Life, Cardiac Surgical Procedures, Heart Valve Diseases, Geriatrics
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