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Randomized Controlled Trial
. 2020 Dec 1;76(22):2595-2606.
doi: 10.1016/j.jacc.2020.09.609.

Pulmonary Hypertension in Transcatheter Mitral Valve Repair for Secondary Mitral Regurgitation: The COAPT Trial

Ori Ben-Yehuda  1 , Bahira Shahim  2 , Shmuel Chen  3 , Mengdan Liu  2 , Bjorn Redfors  2 , Rebecca T Hahn  3 , Federico M Asch  4 , Neil J Weissman  4 , Diego Medvedofsky  4 , Rishi Puri  5 , Samir Kapadia  5 , Anna Sannino  6 , Paul Grayburn  6 , Saibal Kar  7 , Scott Lim  8 , JoAnn Lindenfeld  9 , William T Abraham  10 , Michael J Mack  6 , Gregg W Stone  11
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Free article
Randomized Controlled Trial

Pulmonary Hypertension in Transcatheter Mitral Valve Repair for Secondary Mitral Regurgitation: The COAPT Trial

Ori Ben-Yehuda et al. J Am Coll Cardiol. .
Free article

Abstract

Background: Pulmonary hypertension worsens prognosis in patients with heart failure (HF) and secondary mitral regurgitation (SMR).

Objectives: This study sought to determine whether baseline pulmonary hypertension influences outcomes of transcatheter mitral valve repair (TMVr) in patients with HF with SMR.

Methods: In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial, 614 patients with HF with moderate-to-severe or severe SMR were randomized to TMVr with the MitraClip plus guideline-directed medical therapy (GDMT) (n = 302) versus GDMT alone (n = 312). Baseline pulmonary artery systolic pressure (PASP) estimated from echocardiography was categorized as substantially increased (≥50 mm Hg) versus not substantially increased (<50 mm Hg).

Results: Among 528 patients, 184 (82 TMVr, 102 GDMT) had PASP of ≥50 mm Hg (mean: 59.1 ± 8.8 mm Hg) and 344 (171 TMVr, 173 GDMT) had PASP of <50 mm Hg (mean: 36.3 ± 8.1 mm Hg). Patients with PASP of ≥50 mm Hg had higher 2-year rates of death or HF hospitalization (HFH) compared to those with PASP of <50 mm Hg (68.8% vs. 49.1%; adjusted hazard ratio: 1.52; 95% confidence interval: 1.17 to 1.97; p = 0.002). Rates of death or HFH were reduced by TMVr versus GDMT alone, irrespective of baseline PASP (pinteraction = 0.45). TMVr reduced PASP from baseline to 30 days to a greater than GDMT alone (adjusted least squares mean: -4.0 vs. -0.9 mm Hg; p = 0.006), a change that was associated with reduced risk of death or HFH between 30 days and 2 years (adjusted hazard ratio: 0.91 per -5 mm Hg PASP; 95% confidence interval: 0.86 to 0.96; p = 0.0009).

Conclusions: Elevated PASP is associated with a worse prognosis in patients with HF with severe SMR. TMVr with the MitraClip reduced 30-day PASP and 2-year rates of death or HFH compared with GDMT alone, irrespective of PASP.

Keywords: heart failure; mitral regurgitation; mitral valve repair; pulmonary hypertension; transcatheter.

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Conflict of interest statement

Author Disclosures The COAPT trial was funded by Abbott. Drs. Ben-Yehuda, Shahim, and Redfors are employees of the Cardiovascular Research Foundation which has received research grants in connection with the COAPT trial from Abbott; they have no personal financial relationships with Abbott. Dr. Hahn has received speaker fees from Boston Scientific Corporation, Baylis Medical, Edwards Lifesciences, and Medtronic; has been a consultant 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 are the director and associate director, respectively, of an academic echocardiography core laboratory with institutional contracts with Abbott, Neovasc, Ancora, Medtronic, Boston Scientific, Edwards Lifesciences, Biotronik, and Livanova. Dr. Grayburn has received research grant support from Abbott, Edwards Lifesciences, Medtronic, W.L. Gore, and Boston Scientific; has consulted for Abbott, Edwards, Medtronic, and Neochord; and has imaging core laboratory contracts with Edwards Lifesciences, Neochord, W.L. Gore, and Cardiovalve. 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. Dr. Lim has received research grant support and consulting fees from Abbott Vascular. Dr. Lindenfeld has received consulting fees from Abbott, AstraZeneca, Edwards Lifesciences, Relypsa, Boehringer Ingelheim, V-Wave, CVRx, and Impulse Dynamics; and has received research grant support from AstraZeneca. Dr. Abraham has received research grant support from Abbott; and has received consulting fees from Abbott and Edwards Lifesciences. Dr. Mack has served as coprincipal investigator for the Edwards Lifesciences–sponsored PARTNER 3 trial and the Abbott-sponsored COAPT trial; and has served as study chairman for the Medtronic-sponsored 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 in 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.

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