Author + information
- Received February 7, 2020
- Revision received February 28, 2020
- Accepted March 1, 2020
- Published online March 16, 2020.
- Suzanne V. Arnold, MD, MHAa,b,∗ (, )
- 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
- ↵∗Corresponding author Suzanne V. Arnold, MD, MHA Saint Luke’s Mid America Heart Institute 4401 Wornall Rd Kansas City, MO 64111 Phone: 816-932-8606 Fax: 816-932-5613 Twitter: @arnoldgehrke
Background In the COAPT trial, transcatheter mitral valve repair (TMVr) with the MitraClip rapidly improved health status and reduced the long-term risks of death and heart failure (HF) hospitalization in patients with HF and severe secondary mitral regurgitation (SMR) who remained symptomatic despite maximally-tolerated guideline directed medical therapy (GDMT).
Objective To examine if early health status changes were associated with long-term clinical outcomes in the COAPT population.
Methods We evaluated the association between change in health status (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 and tested whether treatment (TMVr or GDMT alone) modified this association.
Results Among 551 patients with HF and severe SMR who were alive at 1 month, those randomized to TMVr were more likely than 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 of 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 of death or HF hospitalization (HR 0.86, 95% CI 0.81-0.92, 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 (HR 0.79, 95% CI 0.73-0.86, p<0.001).
Conclusion In patients with HF and severe SMR, a short-term change in disease-specific health status was strongly associated with the subsequent long-term risk of 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.
- Heart failure
- health status
- mitral valve
- mitral regurgitation
- mitral valve repair
- randomized clinical trial
Funding: 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 (New York, New York). The authors had unrestricted access to the study data, drafted the manuscript, made the decision to submit for publication, and vouch for the veracity and completeness of its content.
Disclosures: GWS: Consulting income from Neovasc, Gore, Ancora and Valfix; equity/options in Cardiac Success, Ancora and Valfix. MJM: Served as co-primary investigator for the PARTNER Trial for Edwards Lifesciences and COAPT trial for Abbott; served as study chair for the APOLLO trial for Medtronic. AKC: Speakers bureau for Abbott, Edwards Lifesciences, and Medtronic Inc., proctor for Edwards Lifesciences and Medtronic Inc., consulting income from Boston Scientific and Silk Road Medical. SK: Research grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Mitralign; consulting income from Abbott Vascular and Boston Scientific. DSL: Research grant support from Abbott Vascular; consulting income from Abbott Vascular. JL: Research grant support from AstraZeneca; consulting income from Abbott Vascular, Edwards Lifesciences, Boston Scientific, RESMED, Relypsa, Boehringer Ingelheim, and V-Wave. WTA: Research grant support from Abbott Vascular; consulting income from Abbott Vascular. DJC: Research grant support from Abbott Vascular, Edwards Lifesciences, Medtronic, and Boston Scientific; consulting income from Abbott Vascular, Edwards Lifesciences, Medtronic, and Boston Scientific. The other authors report no conflicts.
- Received February 7, 2020.
- Revision received February 28, 2020.
- Accepted March 1, 2020.
- 2020 American College of Cardiology Foundation
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