Focus on Mitral Valve Interventions
NYHA Functional Classification and Outcomes After Transcatheter Mitral Valve Repair in Heart Failure: The COAPT Trial

https://doi.org/10.1016/j.jcin.2020.06.058Get rights and content
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Abstract

Objectives

The aim of this study was to evaluate the outcomes of MitraClip implantation versus guideline-directed medical therapy (GDMT) in patients with secondary mitral regurgitation (SMR) according to baseline functional status as assessed by the widely used New York Heart Association (NYHA) functional classification.

Background

Patients with heart failure (HF) and impaired functional status at baseline have poor prognosis. Whether the effects of transcatheter repair of secondary SMR in patients with HF are influenced by baseline functional status is unknown.

Methods

In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial, patients with HF with moderate to severe or severe SMR who remained symptomatic despite maximally tolerated GDMT were randomized to MitraClip implantation versus GDMT alone. Outcomes were evaluated according to baseline functional status as assessed using the NYHA functional classification. The primary endpoint of interest was the rate of death or HF-related hospitalization (HFH) at 2 years in time-to-first-event analyses.

Results

Among 613 randomized patients, 240 were in NYHA functional class II (39.2%), 322 were in NYHA functional class III (52.5%), and 51 were in ambulatory NYHA functional class IV (8.3%). Rates of death or HFH were progressively higher with increasing NYHA functional class. Compared with GDMT alone, MitraClip implantation resulted in lower 2-year rates of death or HFH consistently in patients in NYHA functional class II (39.7% vs. 63.7%; hazard ratio [HR]: 0.54; 95% confidence interval [CI]: 0.37 to 0.77), NYHA functional class III (46.6% vs. 65.5%; HR: 0.60; 95% CI: 0.45 to 0.82), and NYHA functional class IV (66.7% vs. 85.2%; HR: 0.55; 95% CI: 0.28 to 1.10; pinteraction = 0.86). Greater improvements in quality of life at 2 years were observed in patients treated with the MitraClip compared with GDMT irrespective of baseline functional status.

Conclusions

The NYHA functional classification provides prognostic utility in patients with HF and moderate to severe or severe SMR. In the COAPT trial, the benefits of MitraClip implantation were consistent in patients with better or worse functional status as assessed by NYHA functional class. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial] [COAPT]; NCT01626079)

Key Words

heart failure
medical therapy
MitraClip
NYHA functional class
secondary mitral regurgitation

Abbreviations and Acronyms

6MWD
6-min walk distance
CI
confidence interval
GDMT
guideline-directed medical therapy
HF
heart failure
HFH
heart failure–related hospitalization
HR
hazard ratio
KCCQ-OS
Kansas City Cardiomyopathy Questionnaire Overall Summary
LV
left ventricular
NYHA
New York Heart Association
QOL
quality of life
SMR
secondary mitral regurgitation
TMVr
transcatheter mitral valve repair

Cited by (0)

The COAPT trial was sponsored by Abbott. Dr. Giustino has received consulting fees (advisory board) from Bristol Myers Squibb/Pfizer. Dr. Lindenfeld has received research grant support from AstraZeneca; and has received consulting income from Abbott Vascular, AstraZeneca, CVRx, Edwards Lifesciences, Impulse Dynamics, Boehringer Ingelheim, and V-Wave. Dr. Abraham has received research grant support from Abbott Vascular; and has received consulting income from Abbott Vascular. Dr. Kar has received consulting fees from and is an advisory board member for Boston Scientific; has received consulting fees from and holds stock equity in Valcare; and has received consulting fees from W.L. Gore and Medtronic. Dr. Lim has received research grant support from Abbott, Edwards Lifesciences, Medtronic, and W.L. Gore; is a consultant for Abbott, Edwards Lifesciences, Keystone Heart, Pipeline, Siemens, Valgen, and Venus; is an advisory board member for Ancora and Venus; and holds equity in 510 Kardiac Devices and Venus. Dr. Grayburn has received consulting fees from Abbott Vascular, Edwards Lifesciences, W.L. Gore, Medtronic, and 4C Medical; and has received grant support from Abbott Vascular, Boston Scientific, Cardiovalve, Edwards Lifesciences, W.L. Gore, Medtronic, and NeoChord. Dr. Kapadia holds stock options in Navigate Cardiac Structures. Dr. Cohen has received research grant support from Abbott, Medtronic, Edwards Lifesciences, and Boston Scientific; and has received consulting income from Abbott, Medtronic, Edwards Lifesciences, and Boston Scientific. Dr. Weissman is associate director of an academic echocardiography core laboratory (MedStar Health Research Institute) with institutional contracts with Abbott, Neovasc, Ancora, Mitralign, Medtronic, Boston Scientific, Edwards Lifesciences, Biotronik, and LivaNova. Dr. Mack served as co–primary investigator for the PARTNER trial for Edwards Lifesciences and the COAPT trial for Abbott; and served as study chair for the APOLLO trial for Medtronic. Dr. Stone has received speaking or other honoraria from Cook, Terumo, Qool Therapeutics, and Orchestra Biomed; is a consultant to Valfix, TherOx, Vascular Dynamics, Robocath, HeartFlow, W.L. Gore, Ablative Solutions, Miracor, Neovasc, V-Wave, Abiomed, Ancora, MAIA Pharmaceuticals, Vectorious, Reva, Matrizyme, CardioMech; holds equity or options in Ancora, Qool Therapeutics, Cagent, Applied Therapeutics, the Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, the MedFocus family of funds, and Valfix; and is principal investigator for the COAPT trial (uncompensated). Dr. Kotinkaduwa has reported that she has no relationships relevant to the contents of this paper to disclose.

The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Cardiovascular Interventions author instructions page.