Author + information
- Received January 24, 2019
- Revision received February 13, 2019
- Accepted February 13, 2019
- Published online April 29, 2019.
- Suzanne V. Arnold, MD, MHAa,
- Khaja M. Chinnakondepalli, MSa,
- John A. Spertus, MD, MPHa,
- Elizabeth A. Magnuson, ScDa,
- Suzanne J. Baron, MD, MSca,
- Saibal Kar, MDb,
- D. Scott Lim, MDc,
- Jacob M. Mishell, MDd,
- William T. Abraham, MDe,
- JoAnn A. Lindenfeld, MDf,
- Michael J. Mack, MDg,
- Gregg W. Stone, MDh,
- David J. Cohen, MD, MSca,∗ (, )@djc795@MidAmericaHeart,
- on behalf of the COAPT Investigators
- aSaint Luke’s Mid America Heart Institute and University of Missouri-Kansas City, Kansas City, Missouri
- bCedars-Sinai Medical Center, Los Angeles, California
- cUniversity of Virginia, Charlottesville, Virginia
- dKaiser Permanente-San Francisco Hospital, San Francisco, California
- eOhio State University, Columbus, Ohio
- fVanderbilt Heart and Vascular Institute, Nashville, Tennessee
- gBaylor Scott and White Health, Plano, Texas
- hNew York-Presbyterian Hospital and Cardiovascular Research Foundation, New York, New York
- ↵∗Address for correspondence:
Dr. David J. Cohen, Saint Luke’s Mid America Heart Institute, University of Missouri-Kansas City, 4401 Wornall Road, Kansas City, Missouri 64111.
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) led to reduced heart failure (HF) hospitalizations and improved survival in patients with symptomatic HF and 3+ to 4+ secondary mitral regurgitation (MR) on maximally-tolerated medical therapy. Given the advanced age and comorbidities of these patients, improvement in health status is also an important treatment goal.
Objectives The purpose of this study was to understand the health status outcomes of patients with HF and 3+ to 4+ secondary MR treated with TMVr versus standard care.
Methods The COAPT trial randomized patients with HF and 3+ to 4+ secondary MR to TMVr (n = 302) or standard care (n = 312). Health status was assessed at baseline and at 1, 6, 12, and 24 months with the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the SF-36 health status survey. The primary health status endpoint was the KCCQ overall summary score (KCCQ-OS; range 0 to 100; higher = better; minimum clinically important difference = 5 points).
Results At baseline, patients had substantially impaired health status (mean KCCQ-OS 52.4 ± 23.0). While health status was unchanged over time in the standard care arm, patients randomized to TMVr demonstrated substantial improvement in the KCCQ-OS at 1 month (mean between-group difference 15.9 points; 95% confidence interval [CI]: 12.3 to 19.5 points), with only slight attenuation of this benefit through 24 months (mean between-group difference 12.8 points; 95% CI: 7.5 to 18.2 points). At 24 months, 36.4% of TMVr patients were alive with a moderately large (≥10-point) improvement versus 16.6% of standard care patients (p < 0.001), for a number needed to treat of 5.1 patients (95% CI: 3.6 to 8.7 patients). TMVr patients also reported better generic health status at each timepoint (24-month mean difference in SF-36 summary scores: physical 3.6 points; 95% CI: 1.4 to 5.8 points; mental 3.6 points; 95% CI: 0.8 to 6.4 points).
Conclusions Among patients with symptomatic HF and 3+ to 4+ secondary MR receiving maximally-tolerated medical therapy, edge-to-edge TMVr resulted in substantial early and sustained health status improvement compared with medical therapy alone. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial] [COAPT]; NCT01626079)
The COAPT trial was sponsored by Abbott and designed collaboratively by the principal investigators and the sponsor. The present analysis was conducted by academic investigators at Saint Luke’s Mid America Heart Institute. Dr. Arnold is supported by a Career Development Grant Award (K23 HL116799) from the National Heart, Lung, and Blood Institute. Dr. Spertus owns the copyright for the KCCQ; has equity interest in Health Outcomes Sciences; has received consulting income from Novartis, Bayer, AstraZeneca, V-wave, Corvia, and Janssen; has served on the Advisory Board for United Healthcare; and has served on the Board of Directors for Blue Cross Blue Shield of Kansas City. Dr. Magnuson has received research grant support from Edwards Lifesciences, Medtronic, Boston Scientific, Abbott, and CSI. Dr. Baron has received consulting income from Edwards Lifesciences; and has received research grant support from Boston Scientific. Dr. Kar has received research grant support from Abbott, Boston Scientific, Edwards Lifesciences, and Mitralign; and has received consulting income from Abbott and Boston Scientific. Drs. Lim and Abraham have received research grant support and consulting income from Abbott. Dr. Lindenfeld has received research grant support from AstraZeneca; and has received consulting income from Abbott, Edwards Lifesciences, Boston Scientific, RESMED, Relypsa, Boehringer Ingelheim, and V-Wave. Dr. Mack has served as co-primary investigator for the Partner Trial for Edwards Lifesciences and COAPT trial for Abbott; and has served as Study Chair for the APOLLO trial for Medtronic. Dr. Stone has received consulting income from Claret, Medical Development Technologies, Backbeat, Sirtex, Matrizyme, Miracor, Neovasc, V-wave, Shockwave, Valfix, TherOx, Reva, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions, and Ancora; has received speaker honoraria from Terumo and Amaranth; has received Advisory Board fees from QOOL Therapeutics and SpectraWAVE; has equity/options in Ancora, Cagent, Qool Therapeutics, Aria, Caliber, MedFocus family of funds, Biostar family of funds, Applied Therapeutics, and SpectraWAVE; has served as director of SpectraWave; and his employer, Columbia University, receives royalties for sale of the MitraClip from Abbott. Dr. Cohen has received research grant support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott; and has received consulting fees from Medtronic and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Listen to this manuscript's audio summary by Editor-in-Chief Dr. Valentin Fuster on JACC.org.
- Received January 24, 2019.
- Revision received February 13, 2019.
- Accepted February 13, 2019.
- 2019 American College of Cardiology Foundation
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