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Published on: October 16, 2021
Sex-Specific Outcomes of Transcatheter Mitral-Valve Repair and Medical Therapy for Mitral Regurgitation in
Ioanna Kosmidou1, JoAnn Lindenfeld2, William T Abraham3
1NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York, USA; Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA.
Insights
Transcatheter mitral valve repair (TMVr) improved heart failure outcomes, but its benefit in reducing hospitalizations was less pronounced in women than men after the first year. TMVr consistently reduced mortality for both sexes in the COAPT trial.
Area of Science:
- Cardiology
- Interventional Cardiology
- Heart Failure Management
Background:
- Severe secondary mitral regurgitation (SMR) in heart failure (HF) patients poses significant challenges.
- The impact of sex on treatment outcomes for SMR with transcatheter mitral valve repair (TMVr) remains largely unexplored.
Purpose of the Study:
- To evaluate sex-specific outcomes in patients with HF and severe SMR treated with TMVr plus guideline-directed medical therapy (GDMT) versus GDMT alone.
- To analyze the differential effects of TMVr on heart failure hospitalizations and mortality between men and women within the COAPT trial.
Main Methods:
- Randomized controlled trial (COAPT) comparing TMVr plus GDMT versus GDMT alone.
- Analysis of 2-year outcomes stratified by sex, including heart failure hospitalizations (HFH) and mortality.
- Utilized a joint frailty model to account for competing risks.
Main Results:
- Women were younger with fewer comorbidities but had lower baseline quality of life and functional capacity.
- While GDMT alone showed higher HFH in men, TMVr demonstrated a greater relative reduction in HFH for men compared to women (Pinteraction=0.002).
- TMVr consistently reduced 2-year mortality irrespective of sex (Pinteraction=0.99), with female sex independently associated with lower adjusted mortality risk.
Conclusions:
- TMVr with MitraClip improved clinical outcomes in HF patients with SMR, regardless of sex.
- The reduction in HFH with TMVr was less pronounced in women than men beyond the first year post-treatment.
- While mortality benefits were consistent across sexes, further investigation into sex-specific HFH responses to TMVr is warranted.
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).
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