Sex-Specific Outcomes of Transcatheter Mitral-Valve Repair and Medical Therapy for Mitral Regurgitation in Heart Failure

Ioanna Kosmidou; JoAnn Lindenfeld; William T Abraham; Michael J Rinaldi; Samir R Kapadia; Vivek Rajagopal; Ian J Sarembock; Andreas Brieke; Prakriti Gaba; Jason H Rogers; Bahira Shahim; Björn Redfors; Zixuan Zhang; Michael J Mack; Gregg W Stone

doi:10.1016/j.jchf.2021.04.011

Sex-Specific Outcomes of Transcatheter Mitral-Valve Repair and Medical Therapy for Mitral Regurgitation in Heart Failure

JACC Heart Fail. 2021 Sep;9(9):674-683. doi: 10.1016/j.jchf.2021.04.011. Epub 2021 Aug 11.

Authors

Affiliations

¹ NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York, USA; Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA.
² Advanced Heart Failure and Cardiac Transplantation Section, Vanderbilt Heart and Vascular Institute, Nashville, Tennessee, USA.
³ Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio, USA.
⁴ Sanger Heart & Vascular Institute/Atrium Health, Charlotte, North Carolina, USA.
⁵ Cleveland Clinic, Cleveland, Ohio, USA.
⁶ Piedmont Hospital, Atlanta, Georgia, USA.
⁷ The Christ Hospital and Lindner Clinical Research Center, Cincinnati, Ohio, USA.
⁸ University Of Colorado Hospital, Aurora, Colorado, USA.
⁹ NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York, USA.
¹⁰ UC Davis Medical Center, Davis, California, USA.
¹¹ Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA.
¹² NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York, USA; Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA; Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden.
¹³ Baylor Scott & White Health, Plano, Texas, USA.
¹⁴ Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA; 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: 34391744
DOI: 10.1016/j.jchf.2021.04.011

Abstract

Objectives: This study sought to assess the sex-specific outcomes in patients with heart failure (HF) with 3+ and 4+ secondary mitral regurgitation (SMR) treated with transcatheter mitral valve repair (TMVr) plus guideline-directed medical therapy (GDMT) versus GDMT alone in the COAPT trial.

Background: The impact of sex in patients with HF and severe SMR treated with TMVr with the MitraClip compared with GDMT alone is unknown.

Methods: Patients were randomized 1:1 to TMVr versus GDMT alone. Two-year outcomes were examined according to sex.

Results: Among 614 patients, 221 (36.0%) were women. Women were younger than men and had fewer comorbidities, but reduced quality of life and functional capacity at baseline. In a joint frailty model accounting for the competing risk of death, the 2-year cumulative incidence of the primary endpoint of all HF hospitalizations (HFH) was higher in men compared with women treated with GDMT alone. However, the relative reduction in HFHs with TMVr was greater in men (HR: 0.43; 95% CI: 0.34-0.54) than women (HR: 0.78; 95% CI: 0.57-1.05) (P_interaction = 0.002). A significant interaction between TMVr versus GDMT alone treatment and time was present for all HFHs in women (HR: 0.57; 95% CI: 0.39-0.84, and HR: 1.39; 95% CI: 0.83-2.33 between 0-1 year and 1-2 years after randomization, respectively, P_interaction = 0.007) but not in men (HR: 0.48; 95% CI: 0.36-0.64, and HR: 0.33; 95% CI: 0.21-0.51; P_interaction = 0.16). Female sex was independently associated with a lower adjusted risk of death at 2 years (HR: 0.64; 95% CI: 0.46-0.90; P = 0.011). TMVr consistently reduced 2-year mortality compared with GDMT alone, irrespective of sex (P_interaction = 0.99).

Conclusions: In the COAPT trial, TMVr with the MitraClip resulted in improved clinical outcomes compared with GDMT alone, irrespective of sex. However, the impact of TMVr in reducing HFH was less pronounced in women compared with men beyond the first year after treatment. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Tria] [COAPT]; NCT01626079).

Keywords: heart failure; mortality; sex; transcutaneous mitral valve repair.

Publication types

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

MeSH terms

Cardiac Catheterization
Female
Heart Failure* / surgery
Heart Failure* / therapy
Heart Valve Prosthesis Implantation*
Humans
Male
Mitral Valve Insufficiency* / surgery
Quality of Life
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT01626079