3-Year Outcomes of Transcatheter Mitral Valve Repair in Patients With Heart Failure.

BACKGROUND

In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial, transcatheter mitral valve repair (TMVr) resulted in fewer heart failure hospitalizations (HFHs) and lower mortality at 24 months in patients with heart failure (HF) with mitral regurgitation (MR) secondary to left ventricular dysfunction compared with guideline-directed medical therapy (GDMT) alone.

OBJECTIVES

This study determined if these benefits persisted to 36 months and if control subjects who were allowed to cross over at 24 months derived similar benefit.

METHODS

This study randomized 614 patients with HF with moderate-to-severe or severe secondary MR, who remained symptomatic despite maximally tolerated GDMT, to TMVr plus GDMT versus GDMT alone. The primary effectiveness endpoint was all HFHs through 24-month follow-up. Patients have now been followed for 36 months.

RESULTS

The annualized rates of HFHs per patient-year were 35.5% with TMVr and 68.8% with GDMT alone (hazard ratio [HR]: 0.49; 95% confidence interval [CI]: 0.37 to 0.63; p < 0.001; number needed to treat (NNT) = 3.0; 95% CI: 2.4 to 4.0). Mortality occurred in 42.8% of the device group versus 55.5% of control group (HR: 0.67; 95% CI: 0.52 to 0.85; p = 0.001; NNT = 7.9; 95% CI: 4.6 to 26.1). Patients who underwent TMVr also had sustained 3-year improvements in MR severity, quality-of-life measures, and functional capacity. Among 58 patients assigned to GDMT alone who crossed over and were treated with TMVr, the subsequent composite rate of mortality or HFH was reduced compared with those who continued on GDMT alone (adjusted HR: 0.43; 95% CI: 0.24 to 0.78; p = 0.006).

CONCLUSIONS

Among patients with HF and moderate-to-severe or severe secondary MR who remained symptomatic despite GDMT, TMVr was safe, provided a durable reduction in MR, reduced the rate of HFH, and improved survival, quality of life, and functional capacity compared with GDMT alone through 36 months. Surviving patients who crossed over to device treatment had a prognosis comparable to those originally assigned to transcatheter therapy. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation [COAPT]; NCT01626079).

Informations de copyright

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Funding Support and Author Disclosures This study was supported by Abbott. Dr. Mack has received grant support from Abbott. Dr. Lindenfeld has received grant support from AstraZeneca; and has received consulting fees from Abbott, AstraZeneca, CVRx, Edwards Lifesciences, Impulse Dynamics, Boehringer Ingelheim, VoluMetrix, and V-Wave. Dr. Abraham has received personal fees from Abbott; has received consulting fees from Boehringer Ingelheim, Respicardia, Sensible Medical, CVRx, and Impulse Dynamics; and has received salary support from V-Wave Medical, all for work done in the field of heart failure. Dr. Kar has received grants from Abbott, Boston Scientific, Edwards Lifesciences, and 4TECH; has been a consultant for Boston Scientific, Edwards Lifesciences, Medtronic, and 4TECH; and holds stock options in 4TECH. Dr. Lim has received institutional grant support from Abbott. Dr. Grayburn has received grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, W.L. Gore, Neochord, and CardioValve; and has received personal fees from Abbott, Edwards Lifesciences, Medtronic, W.L. Gore, and 4C Medical. Dr. Rinaldi has been a consultant and speaker for Abbott, Boston Scientific, and Edwards Lifesciences; has taught courses and has been a proctor for Abbott and Edwards Lifesciences; and has been a member of the advisory board and received a research grant for Boston Scientific. Dr. Sarembock has been a consultant for Boston Scientific. Dr. Rogers has received a research grant and physician training services from and has been a member of the advisory board for Abbott. Dr. Marx has received honorarium for membership in CEC from the Cardiovascular Research Foundation. Dr. Cohen has received institutional research grants and consulting fees from Abbott, Edwards LifeSciences, Medtronic, and Boston Scientific. Dr. Weissman has received grants from Abbott, Boston Scientific, Medtronic, and Edwards Lifesciences. Dr. Stone has been a speaker for and has received honoraria from Cook, Terumo, QOOL Therapeutics, and Orchestra Biomed; has been a consultant for Valfix, TherOx, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions, Miracor, Neovasc, V-Wave, Abiomed, Ancora, MAIA Pharmaceuticals, Vectorious, Reva, Matrizyme, and Cardiomech; and holds equity/options from Ancora, Qool Therapeutics, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, MedFocus family of funds, and Valfix. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.