Author + information
- Received February 7, 2020
- Revision received February 28, 2020
- Accepted March 1, 2020
- Published online April 27, 2020.
- Suzanne V. Arnold, MD, MHAa,b,∗ (, )@arnoldgehrke,
- Gregg W. Stone, MDc,d,
- Michael J. Mack, MDe,
- Adnan K. Chhatriwalla, MDa,b,
- Bethany A. Austin, MDa,b,
- Zixuan Zhang, MSc,
- Ori Ben-Yehuda, MDc,f,
- Saibal Kar, MDg,
- D. Scott Lim, MDh,
- JoAnn Lindenfeld, MDi,
- William T. Abraham, MDj,
- David J. Cohen, MD, MScb,
- on behalf of the COAPT Investigators
- aSaint Luke’s Mid America Heart Institute, Kansas City, Missouri
- bUniversity of Missouri–Kansas City, Kansas City, Missouri
- cClinical Trials Center, Cardiovascular Research Foundation, New York, New York
- dThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York
- eBaylor Scott & White Health, Plano, Texas
- fNewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York
- gCedars-Sinai Medical Center, Los Angeles, California
- hDivision of Cardiology, University of Virginia, Charlottesville, Virginia
- iVanderbilt Heart and Vascular Institute, Nashville, Tennessee
- jDivision of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio
- ↵∗Address for correspondence:
Dr. Suzanne V. Arnold, Saint Luke’s Mid America Heart Institute, 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) with the MitraClip rapidly improved health status and reduced the long-term risks for death and heart failure (HF) hospitalization in patients with HF and severe secondary mitral regurgitation who remained symptomatic despite maximally tolerated guideline-directed medical therapy (GDMT).
Objectives The aim of this study was to examine if early health status changes were associated with long-term clinical outcomes in the COAPT population.
Methods The association between change in health status (Kansas City Cardiomyopathy Questionnaire overall summary score [KCCQ-OS]) from baseline to 1 month and the composite rate of death or HF hospitalization between 1 month and 2 years in the COAPT trial were evaluated, and whether treatment (TMVr or GDMT alone) modified this association was tested.
Results Among 551 patients with HF and severe secondary mitral regurgitation who were alive at 1 month, those randomized to TMVr were more likely than those randomized to GDMT alone to achieve a ≥10-point improvement in KCCQ-OS from baseline to 1 month (TMVr, 58%; GDMT alone, 26%). Early improvement in KCCQ-OS was inversely associated with the risk for death or HF hospitalization between 1 month and 2 years (p < 0.001). When analyzed as a continuous variable, a 10-point increase in KCCQ-OS was associated with a 14% lower risk for death or HF hospitalization (hazard ratio: 0.86; 95% confidence interval: 0.81 to 0.92; p < 0.001), with no significant interaction with treatment group (pinteraction = 0.17). After adjusting for demographic and clinical factors, the association between change in KCCQ-OS and outcomes was strengthened (hazard ratio: 0.79; 95% confidence interval: 0.73 to 0.86; p < 0.001).
Conclusions In patients with HF and severe secondary mitral regurgitation, a short-term change in disease-specific health status was strongly associated with the subsequent long-term risk for death or HF hospitalization. These findings reinforce the prognostic utility of serial KCCQ-OS assessments to identify patients at risk for poor long-term clinical outcomes in this population. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial]; NCT01626079)
- health status
- heart failure
- mitral regurgitation
- mitral valve
- mitral valve repair
- randomized clinical trial
The COAPT trial was sponsored by Abbott and designed collaboratively by the principal investigators and the sponsor. The present analysis was conducted by the first and last authors in conjunction with academic investigators at the Clinical Trials Center of the Cardiovascular Research Foundation. Dr. Stone has received consulting income from Neovasc, Gore, Ancora, and Valfix; and holds equity or options in Cardiac Success, Ancora, and Valfix. Dr. Mack has served as a co–primary investigator for the PARTNER trial for Edwards Lifesciences and the COAPT trial for Abbott; and has served as study chair for the APOLLO trial for Medtronic. Dr. Chhatriwalla is a member of the Speakers Bureau for Abbott, Edwards Lifesciences, and Medtronic; is a proctor for Edwards Lifesciences and Medtronic; and has received consulting income from Boston Scientific and Silk Road Medical. Dr. Kar has received research grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Mitralign; and has received consulting income from Abbott Vascular and Boston Scientific. Dr. Lim has received research grant support and consulting income from Abbott Vascular. Dr. Lindenfeld has received research grant support from AstraZeneca; and has received consulting income from Abbott Vascular, Edwards Lifesciences, Boston Scientific, RESMED, Relypsa, Boehringer Ingelheim, and V-Wave. Dr. Abraham has received research grant support and consulting income from Abbott Vascular. Dr. Cohen has received research grant support from Abbott Vascular, Edwards Lifesciences, Medtronic, and Boston Scientific; and has received consulting income from Abbott Vascular, Edwards Lifesciences, Medtronic, and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Thomas Meinertz, MD, PhD, served as Guest Associate Editor for this paper.
- Received February 7, 2020.
- Revision received February 28, 2020.
- Accepted March 1, 2020.
- 2020 American College of Cardiology Foundation
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