Hospitalizations and Mortality in Patients With Secondary Mitral Regurgitation and Heart Failure: The COAPT Trial

Gennaro Giustino; Anton Camaj; Samir R Kapadia; Saibal Kar; William T Abraham; JoAnn Lindenfeld; D Scott Lim; Paul A Grayburn; David J Cohen; Björn Redfors; Zhipeng Zhou; Stuart J Pocock; Federico M Asch; Michael J Mack; Gregg W Stone

doi:10.1016/j.jacc.2022.08.803

Hospitalizations and Mortality in Patients With Secondary Mitral Regurgitation and Heart Failure: The COAPT Trial

J Am Coll Cardiol. 2022 Nov 15;80(20):1857-1868. doi: 10.1016/j.jacc.2022.08.803.

Authors

Gennaro Giustino¹, Anton Camaj², Samir R Kapadia³, Saibal Kar⁴, William T Abraham⁵, JoAnn Lindenfeld⁶, D Scott Lim⁷, Paul A Grayburn⁸, David J Cohen⁹, Björn Redfors¹⁰, Zhipeng Zhou¹⁰, Stuart J Pocock¹¹, Federico M Asch¹², Michael J Mack¹³, Gregg W Stone¹⁴

Affiliations

¹ The Zena and Michael A. Wiener Cardiovascular Institute Icahn School of Medicine at Mount Sinai, New York, New York, USA. Electronic address: https://twitter.com/@g_giustinoMD.
² The Zena and Michael A. Wiener Cardiovascular Institute Icahn School of Medicine at Mount Sinai, New York, New York, USA.
³ Cleveland Clinic, Cleveland, Ohio, USA.
⁴ Los Robles Regional Medical Center, Thousand Oaks, California, USA; Bakersfield Heart Hospital, Bakersfield, California, USA.
⁵ Division of Cardiovascular Medicine, The Ohio State University Medical Center, Columbus, Ohio, USA.
⁶ Advanced Heart Failure and Cardiac Transplantation Section, Vanderbilt Heart and Vascular Institute, Nashville, Tennessee, USA.
⁷ Division of Cardiology, University of Virginia, Charlottesville, Virginia, USA.
⁸ Baylor University Medical Center, Baylor Heart and Vascular Institute, Dallas, Texas, USA.
⁹ St Francis Hospital, Roslyn, New York, USA; Clinical Trials Center Cardiovascular Research Foundation, New York, New York, USA.
¹⁰ Clinical Trials Center Cardiovascular Research Foundation, New York, New York, USA.
¹¹ London School of Hygiene and Tropical Medicine, London, United Kingdom.
¹² MedStar Health Research Institute, Washington, DC, USA; Georgetown University, Washington, DC, USA.
¹³ Baylor Scott and White Health, Plano, Texas, USA.
¹⁴ The Zena and Michael A. Wiener Cardiovascular Institute Icahn School of Medicine at Mount Sinai, New York, New York, USA. Electronic address: gregg.stone@mountsinai.org.

PMID: 36357085
DOI: 10.1016/j.jacc.2022.08.803

Abstract

Background: The impact of transcatheter edge-to-edge repair (TEER) on the rate and prognostic impact of hospitalizations in patients with heart failure (HF) and severe secondary mitral regurgitation is unknown.

Objectives: This study sought to evaluate the effect of the MitraClip percutaneous edge-to edge repair system on fatal and nonfatal hospitalizations and their relationship with mortality in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial.

Methods: Patients with HF (n = 614) with severe secondary mitral regurgitation were randomized to TEER plus guideline-directed medical therapy (GDMT) versus GDMT alone. Hospitalizations were classified as fatal if death occurred during that hospitalization or nonfatal if the patient was discharged alive.

Results: At 2 years, TEER treatment, compared with GDMT alone, resulted in lower time-to-first-event rates of any heart failure hospitalization (HFH) (34.8% vs 56.4%; HR: 0.51; 95% CI: 0.39-0.66) and fatal HFH (6.5% vs 12.6%; HR: 0.47; 95% CI: 0.26-0.85). TEER also resulted in lower rates of all-cause nonfatal and fatal hospitalizations. During the 2-year follow-up period, patients who underwent TEER spent an average of 2 more months alive and out of the hospital than did patients treated with GDMT alone (581 ± 27 days vs 519 ± 26 days; P = 0.002). All HFHs (adjusted HR: 6.37; 95% CI: 4.63-8.78) and nonfatal HFHs (adjusted HR: 1.78; 95% CI: 1.27-2.49) were consistently independently associated with increased 2-year mortality in both the TEER and GDMT groups (P_interaction = 0.34 and 0.39, respectively).

Conclusions: In the COAPT trial, compared with GDMT alone, patients with HF and severe secondary mitral regurgitation undergoing TEER with the percutaneous edge-to edge repair system had lower 2-year rates of fatal and nonfatal all-cause hospitalizations and HFH and spent more time alive and out of the hospital. HFHs were strongly associated with mortality, irrespective of treatment. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial] and COAPT CAS [COAPT]; NCT01626079).

Keywords: guideline-directed medical therapy; in-hospital mortality; mitral valve insufficiency; transcatheter mitral valve repair.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Heart Failure* / complications
Heart Failure* / therapy
Heart Valve Prosthesis Implantation* / methods
Hospitalization
Humans
Mitral Valve Insufficiency* / complications
Mitral Valve Insufficiency* / surgery
Outcome Assessment, Health Care
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT01626079