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Randomized Controlled Trial
. 2021 Aug;9(8):559-567.
doi: 10.1016/j.jchf.2021.03.011.

Impact of Diabetes on Outcomes After Transcatheter Mitral Valve Repair in Heart Failure: COAPT Trial

Bahira Shahim  1 , Ori Ben-Yehuda  2 , Shmuel Chen  3 , Björn Redfors  4 , Mahesh V Madhavan  3 , Saibal Kar  5 , D Scott Lim  6 , Federico M Asch  7 , Neil J Weissman  7 , David J Cohen  8 , Suzanne V Arnold  9 , Mengdan Liu  1 , JoAnn Lindenfeld  10 , William T Abraham  11 , Michael J Mack  12 , Gregg W Stone  13
Affiliations
Free article
Randomized Controlled Trial

Impact of Diabetes on Outcomes After Transcatheter Mitral Valve Repair in Heart Failure: COAPT Trial

Bahira Shahim et al. JACC Heart Fail. 2021 Aug.
Free article

Abstract

Objectives: This paper sought to determine whether diabetes influences the outcomes of transcatheter mitral valve repair (TMVr) in patients with heart failure (HF) and secondary mitral regurgitation (SMR).

Background: Diabetes is associated with worse outcomes in patients with HF.

Methods: The COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With functional Mitral Regurgitation) trial randomized HF patients with 3+ or 4+ SMR to MitraClip plus guideline-directed medical therapy (GDMT) versus GDMT alone. Two-year outcomes were evaluated in patients with versus without diabetes.

Results: Of 614 patients, 229 (37.3%) had diabetes. Diabetic patients had higher 2-year rates of death than those without diabetes (40.8% vs 32.3%, respectively; adjusted P = 0.04) and tended to have higher rates of HF hospitalization (HFH) (HFH: 50.1% vs 43.0%, respectively; adjusted P = 0.07). TMVr reduced the 2-year rate of death consistently in patients with (30.3% vs 49.9%, respectively; adjusted HR: 0.51; 95% CI: 0.32 to 0.81) and without (27.0% vs 38.3%, respectively; adjusted HR: 0.57; 95% CI: 0.39-0.84) diabetes (Pinteraction = 0.72). TMVr also consistently reduced the 2-year rates of HFH in patients with (32.2% vs 54.8%, respectively; adjusted HR: 0.41; 95% CI: 0.28-0.58) and without (41.5% vs 59.0%, respectively; adjusted HR: 0.54: 95% CI 0.35-0.82) diabetes (Pinteraction = 0.33). Greater movements in quality-of-life (QOL) and exercise capacity occurred with TMVr than with GDMT alone, regardless of diabetic status.

Conclusions: Among HF patients with severe SMR in the COAPT trial, those with diabetes had a worse prognosis. Nonetheless, diabetic and nondiabetic patients had consistent reductions in the 2-year rates of death and HFH and improvements in QOL and functional capacity following TMVr treatment using the MitraClip than with maintenance on GDMT alone. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [COAPT]; NCT01626079).

Keywords: diabetes; heart failure; mitral regurgitation; transcatheter mitral valve repair.

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Conflict of interest statement

Funding Support and Author Disclosures The COAPT trial was supported by Abbott. Dr Shahim is supported by the Foundation Blanceflor and the Swedish Heart-Lung Foundation. Dr Madhavan has received an institutional grant to Columbia University Irving Medical Center from the National Institutes of Health/National Heart Lung Blood Institute grant T32 HL007854. Dr Kar is a consultant and an advisory board member for Boston Scientific; and is a consultant for and holds stock equity in Valcare; and is a consultant for WL Gore and Medtronic. Dr Lim has received research support from Abbott, Edwards Lifesciences, Medtronic, and WL Gore; and is a consultant for Abbott, Edwards Lifesciences, Keystone Heart, Pipeline, Siemens, Valgen, and Venus; and is an advisory board member for Ancora and Venus; and holds equity in 510Kardiac and Venus. Drs. Asch and Weissman have institutional contracts with Abbott, Neovasc, Ancora, Mitralign, Medtronic, Boston Scientific, Edwards Lifesciences, Biotronik, and Livanova. Dr Cohen has received research support from Abbott, Medtronic, Edwards Lifesciences, and Boston Scientific; and is a consultant for Abbott, Medtronic, Edwards Lifesciences, and Boston Scientific. Dr Lindenfeld has received research support from AstraZeneca; and is a consultant for Abbott Vascular, AstraZeneca, CVRx, Edwards Lifesciences, Impulse Dynamics, Boehringer Ingelheim, VoluMetrix, and V-Wave. Dr Abraham has received research support from Abbott Vascular; and he is a consultant for Abbott Vascular. Dr Mack has served as co-primary investigator for the PARTNER trial for Edwards Lifesciences, the COAPT trial for Abbott, and as study chair for the APOLLO trial for Medtronic. Dr Stone has received speaker and honoraria fees from Cook, Terumo, and Orchestra Biomed; and is a consultant for Valfix, TherOx, Vascular Dynamics, Robocath, HeartFlow, WL Gore, Ablative Solutions, Miracor, Neovasc, V-Wave, Abiomed, Ancora, MAIA Pharmaceuticals, Vectorious, Reva, Matrizyme, and Cardiomech; and holds equity in Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, and MedFocus family of funds, Valfix. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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