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

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Sex-Specific Outcomes of Transcatheter Mitral-Valve Repair and Medical Therapy for Mitral Regurgitation in Heart Failure
JACC: Heart Failure ( IF 10.3 ) Pub Date : 2021-08-11 , DOI: 10.1016/j.jchf.2021.04.011
Ioanna Kosmidou ₁ , JoAnn Lindenfeld ₂ , William T Abraham ₃ , Michael J Rinaldi ₄ , Samir R Kapadia ₅ , Vivek Rajagopal ₆ , Ian J Sarembock ₇ , Andreas Brieke ₈ , Prakriti Gaba ₉ , Jason H Rogers ₁₀ , Bahira Shahim ₁₁ , Björn Redfors ₁₂ , Zixuan Zhang ₁₁ , Michael J Mack ₁₃ , Gregg W Stone ₁₄

Affiliation

NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York, USA; Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA.
Advanced Heart Failure and Cardiac Transplantation Section, Vanderbilt Heart and Vascular Institute, Nashville, Tennessee, USA.
Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio, USA.
Sanger Heart & Vascular Institute/Atrium Health, Charlotte, North Carolina, USA.
Cleveland Clinic, Cleveland, Ohio, USA.
Piedmont Hospital, Atlanta, Georgia, USA.
The Christ Hospital and Lindner Clinical Research Center, Cincinnati, Ohio, USA.
University Of Colorado Hospital, Aurora, Colorado, USA.
NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York, USA.
UC Davis Medical Center, Davis, California, USA.
Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA.
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.
Baylor Scott & White Health, Plano, Texas, USA.
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.

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. The impact of sex in patients with HF and severe SMR treated with TMVr with the MitraClip compared with GDMT alone is unknown. Patients were randomized 1:1 to TMVr versus GDMT alone. Two-year outcomes were examined according to sex. 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) ( = 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, = 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; = 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; 0.011). TMVr consistently reduced 2-year mortality compared with GDMT alone, irrespective of sex ( = 0.99). 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]; )

中文翻译：

心力衰竭二尖瓣反流经导管二尖瓣修复和药物治疗的性别特异性结果

本研究旨在评估经导管二尖瓣修复术 (TMVr) 加指南指导药物治疗 (GDMT) 与 GDMT 治疗的 3+ 和 4+ 继发性二尖瓣反流 (SMR) 心力衰竭 (HF) 患者的性别特异性结局独自参加 COAPT 试验。与单独使用 GDMT 相比，性别对使用 TMVr 联合 MitraClip 治疗的心力衰竭和严重 SMR 患者的影响尚不清楚。患者按 1:1 的比例随机分配至 TMVr 组和单独的 GDMT 组。根据性别检查两年的结果。 614 名患者中，221 名（36.0%）为女性。女性比男性更年轻，合并症也更少，但基线时的生活质量和功能能力有所下降。在考虑死亡竞争风险的关节衰弱模型中，与仅接受 GDMT 治疗的女性相比，男性所有 HF 住院 (HFH) 主要终点的 2 年累积发生率较高。然而，男性 (HR: 0.43; 95% CI: 0.34-0.54) 相对于 TMVr 的 HFH 降低幅度大于女性 (HR: 0.78; 95% CI: 0.57-1.05) (= 0.002)。对于女性的所有 HFH，TMVr 与单独 GDMT 治疗和时间之间存在显着的交互作用（HR：0.57；95% CI：0.39-0.84，HR：1.39；95% CI：0-1 年和 1 年间）随机化后-2 年分别 = 0.007），但男性则不然（HR：0.48；95% CI：0.36-0.64；HR：0.33；95% CI：0.21-0.51；= 0.16）。女性与 2 岁时较低的调整后死亡风险独立相关（HR：0.64；95% CI：0.46-0.90；0.011）。与单独使用 GDMT 相比，TMVr 持续降低了 2 年死亡率，无论性别如何 (= 0.99)。在 COAPT 试验中，无论性别，与单独使用 GDMT 相比，TMVr 与 MitraClip 均可改善临床结果。然而，治疗后第一年之后，与男性相比，TMVr 在减少 HFH 方面对女性的影响不太明显。（MitraClip 经皮治疗功能性二尖瓣反流心力衰竭患者的心血管结果评估 [COAPT Tria] [COAPT]；）

更新日期：2021-08-11

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