Author + information
- Received June 30, 2020
- Revision received July 8, 2020
- Accepted July 9, 2020
- Published online September 7, 2020.
- Rebecca T. Hahn, MDa,∗ (, )
- Federico Asch, MDb,
- Neil J. Weissman, MDb,
- Paul Grayburn, MDc,
- Saibal Kar, MDd,
- Scott Lim, MDe,
- Ori Ben-Yehuda, MDf,
- Bahira Shahim, MD, PhDf,
- Shmuel Chen, MD, PhDa,f,
- Mengdan Liu, MSf,
- Bjorn Redfors, MD, PhDf,
- Diego Medvedofsky, MDb,
- Rishi Puri, MD, PhDg,
- Samir Kapadia, MDg,
- Anna Sannino, MD, PhDc,
- JoAnn Lindenfeld, MDh,
- William T. Abraham, MDi,
- Michael J. Mack, MDc and
- Gregg W. Stone, MDf,j
- aColumbia University Medical Center, New York Presbyterian Hospital, New York, New York
- bMedstar Health Research Institute, Washington, DC
- cBaylor Scott & White Health, Plano, Texas
- dCedars Sinai Medical Center, Los Angeles, California
- eUniversity of Virginia, Charlottesville, Virginia
- fCardiovascular Research Foundation, New York, New York
- gCleveland Clinic, Cleveland, Ohio
- hVanderbilt University Medical Center, Nashville, Tennessee
- iOhio State University Medical Center, Columbus, Ohio
- jThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York
- ↵∗Address for correspondence:
Dr. Rebecca T. Hahn, Columbia University Medical Center, New York–Presbyterian Hospital, 177 Fort Washington Avenue, New York, New York 10032.
Background The presence of tricuspid regurgitation (TR) may affect prognosis in patients with mitral regurgitation (MR).
Objectives This study sought to determine the impact of TR on outcomes in patients with heart failure and severe secondary MR randomized to guideline-directed medical therapy (GDMT) or edge-to-edge repair with the MitraClip in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial.
Methods A total of 614 patients with symptomatic heart failure with moderate to severe (3+) or severe (4+) secondary MR were randomized to maximally tolerated GDMT plus MitraClip or GDMT alone; 599 had core laboratory evaluable echocardiograms. Patients were divided into 2 groups by baseline TR severity: none/trace/mild TR (≤Mild TR) (n = 501 [83.6%]) and moderate/severe TR (≥Mod TR) (n = 98 [16.4%]). Two-year composite endpoints of death or heart failure hospitalization (HFH) and the individual endpoints were analyzed.
Results Patients with ≥Mod TR were more likely to be New York Heart Association functional class III/IV (p < 0.0001) and have a Society of Thoracic Surgeons score of ≥8 (p < 0.0001), anemia (p = 0.02), chronic kidney disease (p = 0.003), and higher N-terminal pro–B-type natriuretic peptide (p = 0.02) than those with ≤Mild TR. Patients with ≥Mod TR had more severe MR (p = 0.0005) despite smaller left ventricular volumes (p = 0.005) and higher right ventricular systolic pressure (p < 0.0001). At 2 years, the composite rate of death or HFH was higher in patients with ≥Mod TR compared with ≤Mild TR treated with GDMT alone (83.0% vs. 64.3%; hazard ratio: 1.74; 95% confidence interval: 1.24 to 2.45; p = 0.001) but not following MitraClip (48.2% vs. 44.0%; hazard ratio: 1.14; 95% confidence interval: 0.71 to 1.84; p = 0.59). Rates of death or HFH, as well as death and HFH alone, were reduced by MitraClip compared with GDMT, irrespective of baseline TR grade (pinteraction = 0.16, 0.29, and 0.21 respectively).
Conclusions Patients with severe secondary MR who also had ≥Mod TR had worse clinical and echocardiographic characteristics and worse clinical outcomes compared to those with ≤Mild TR. Within the COAPT trial, MitraClip improved outcomes in patients with and without ≥Mod TR severity compared with GDMT alone. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [COAPT]; NCT01626079)
Dr. Hahn has received speaker fees from Boston Scientific Corporation, Baylis Medical, Edwards Lifesciences, and Medtronic; has provided consulting for Abbott Structural, Edwards Lifesciences, Gore & Associates, Medtronic, Navigate, and Philips Healthcare; has received nonfinancial support from 3mensio; has equity with Navigate; and is the chief scientific officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Drs. Asch and Weissman have core lab contracts with Abbott, Neovasc, Ancora, Medtronic, Boston Scientific Corporation, Edwards Lifesciences, Biotronik, and Livanova, for which they receive no direct compensation. Dr. Grayburn has received research grants from Abbott Vascular, Boston Scientific, Cardiovalve, Edwards Lifesciences, W.L. Gore, Medtronic, and Neochord; and receives consulting fees from Abbott Vascular, Edwards Lifesciences, W.L. Gore, and 4C Medical. Dr. Kar has received research grants from Abbott, Boston Scientific, Edwards, and Mitralign; and has received consulting fees from Abbott and Boston Scientific. Dr. Lim receives research grants to his institution on his behalf from Abbott Vascular, Edwards Lifesciences, Medtronic, and W.L. Gore; and receives consulting fees from Abbott Vascular, Edwards Lifesciences, and W.L. Gore. Dr. Lindenfeld has received consulting fees from Abbott, Edwards Lifesciences, Boston Scientific, Relypsa, Boehringer Ingelheim, V-Wave, CVRx, and Impulse Dynamics; and has received a research grant from AstraZeneca. Dr. Abraham has received research funding from Abbott; and has received consulting fees from Abbott and Edwards Lifesciences. Dr. Mack has nonfinancial relationships with Edwards Lifesciences (co–principal investigator of the PARTNER 3 trial), Abbott (co–principal investigator of the COAPT trial), and Medtronic (study chair of the APOLLO trial). Dr. Stone has received speaker honoraria from Cook and Terumo; has served as a consultant to Valfix, TherOx, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions, Miracor, Neovasc, V-Wave, Abiomed, Ancora, MAIA Pharmaceuticals, Vectorious, Reva, and Matrizyme; and owns equity/options from Ancora, Qool Therapeutics, Cagent, Applied Therapeutics, the Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, the MedFocus family of funds, and Valfix. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Yee-Ping Sun, MD, served as Guest Associate Editor for this paper. Deepak L. Bhatt, MD, MPH, served as Guest Editor-in-Chief for this paper.
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 author instructions page.
- Received June 30, 2020.
- Revision received July 8, 2020.
- Accepted July 9, 2020.
- 2020 American College of Cardiology Foundation
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