Sex-Specific Outcomes of Transcatheter Mitral-Valve Repair and Medical Therapy for Mitral Regurgitation in Heart Failure.
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) (Pinteraction = 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, Pinteraction = 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; Pinteraction = 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 (Pinteraction = 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).
['Kosmidou|Ioanna|I|', 'Lindenfeld|JoAnn|J|', 'Abraham|William T|WT|', 'Rinaldi|Michael J|MJ|', 'Kapadia|Samir R|SR|', 'Rajagopal|Vivek|V|', 'Sarembock|Ian J|IJ|', 'Brieke|Andreas|A|', 'Gaba|Prakriti|P|', 'Rogers|Jason H|JH|', 'Shahim|Bahira|B|', 'Redfors|Björn|B|', 'Zhang|Zixuan|Z|', 'Mack|Michael J|MJ|', 'Stone|Gregg W|GW|']
D006328:Cardiac Catheterization D005260:Female D006333:Heart Failure D019918:Heart Valve Prosthesis Implantation D006801:Humans D008297:Male D008944:Mitral Valve Insufficiency D011788:Quality of Life D016896:Treatment Outcome
heart failure sex mortality transcutaneous mitral valve repair