PMID- 33092705
OWN - NLM
STAT- MEDLINE
DCOM- 20210727
LR  - 20210727
IS  - 1876-7605 (Electronic)
IS  - 1936-8798 (Linking)
VI  - 13
IP  - 20
DP  - 2020 Oct 26
TI  - NYHA Functional Classification and Outcomes After Transcatheter Mitral Valve 
      Repair in Heart Failure: The COAPT Trial.
PG  - 2317-2328
LID - S1936-8798(20)31472-2 [pii]
LID - 10.1016/j.jcin.2020.06.058 [doi]
AB  - 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; 
      p(interaction) = 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).
CI  - Copyright (c) 2020. Published by Elsevier Inc.
FAU - Giustino, Gennaro
AU  - Giustino G
AD  - The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine 
      at Mount Sinai, New York, New York.
FAU - Lindenfeld, JoAnn
AU  - Lindenfeld J
AD  - Advanced Heart Failure and Cardiac Transplantation Section, Vanderbilt Heart and 
      Vascular Institute, Nashville, Tennessee.
FAU - Abraham, William T
AU  - Abraham WT
AD  - Division of Cardiovascular Medicine, The Ohio State University College of 
      Medicine, Columbus, Ohio.
FAU - Kar, Saibal
AU  - Kar S
AD  - Los Robles Regional Medical Center, Thousand Oaks, California; Bakersfield Heart 
      Hospital, Bakersfield, California.
FAU - Lim, D Scott
AU  - Lim DS
AD  - Division of Cardiology, University of Virginia, Charlottesville, Virginia.
FAU - Grayburn, Paul A
AU  - Grayburn PA
AD  - Baylor University Medical Center, Baylor Heart and Vascular Institute, Dallas, 
      Texas.
FAU - Kapadia, Samir R
AU  - Kapadia SR
AD  - Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland 
      Clinic, Cleveland, Ohio.
FAU - Cohen, David J
AU  - Cohen DJ
AD  - University of Missouri-Kansas City School of Medicine, Kansas City, Missouri.
FAU - Kotinkaduwa, Lak N
AU  - Kotinkaduwa LN
AD  - Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.
FAU - Weissman, Neil J
AU  - Weissman NJ
AD  - MedStar Health Research Institute, Washington, DC; Georgetown University, 
      Washington, DC.
FAU - Mack, Michael J
AU  - Mack MJ
AD  - Baylor Scott and White Heart Hospital Plano, Plano, Texas.
FAU - Stone, Gregg W
AU  - Stone GW
AD  - The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine 
      at Mount Sinai, New York, New York; Clinical Trials Center, Cardiovascular 
      Research Foundation, New York, New York. Electronic address: 
      gregg.stone@mountsinai.org.
LA  - eng
SI  - ClinicalTrials.gov/NCT01626079
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - JACC Cardiovasc Interv
JT  - JACC. Cardiovascular interventions
JID - 101467004
SB  - IM
CIN - JACC Cardiovasc Interv. 2020 Oct 26;13(20):2329-2330. PMID: 33092706
MH  - *Heart Failure/surgery
MH  - *Heart Valve Prosthesis Implantation
MH  - Humans
MH  - Mitral Valve/surgery
MH  - Quality of Life
MH  - Treatment Outcome
OTO - NOTNLM
OT  - MitraClip
OT  - NYHA functional class
OT  - heart failure
OT  - medical therapy
OT  - secondary mitral regurgitation
EDAT- 2020/10/24 06:00
MHDA- 2021/07/28 06:00
CRDT- 2020/10/23 05:34
PHST- 2020/06/01 00:00 [received]
PHST- 2020/06/24 00:00 [revised]
PHST- 2020/06/30 00:00 [accepted]
PHST- 2020/10/23 05:34 [entrez]
PHST- 2020/10/24 06:00 [pubmed]
PHST- 2021/07/28 06:00 [medline]
AID - S1936-8798(20)31472-2 [pii]
AID - 10.1016/j.jcin.2020.06.058 [doi]
PST - ppublish
SO  - JACC Cardiovasc Interv. 2020 Oct 26;13(20):2317-2328. doi: 
      10.1016/j.jcin.2020.06.058.