Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City, Kansas City, Missouri.
Cedars-Sinai Medical Center, Los Angeles, California.
J Am Coll Cardiol. 2019 May 7;73(17):2123-2132. doi: 10.1016/j.jacc.2019.02.010. Epub 2019 Mar 17.
In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial, transcatheter mitral valve repair (TMVr) led to reduced heart failure (HF) hospitalizations and improved survival in patients with symptomatic HF and 3+ to 4+ secondary mitral regurgitation (MR) on maximally-tolerated medical therapy. Given the advanced age and comorbidities of these patients, improvement in health status is also an important treatment goal.
The purpose of this study was to understand the health status outcomes of patients with HF and 3+ to 4+ secondary MR treated with TMVr versus standard care.
The COAPT trial randomized patients with HF and 3+ to 4+ secondary MR to TMVr (n = 302) or standard care (n = 312). Health status was assessed at baseline and at 1, 6, 12, and 24 months with the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the SF-36 health status survey. The primary health status endpoint was the KCCQ overall summary score (KCCQ-OS; range 0 to 100; higher = better; minimum clinically important difference = 5 points).
At baseline, patients had substantially impaired health status (mean KCCQ-OS 52.4 ± 23.0). While health status was unchanged over time in the standard care arm, patients randomized to TMVr demonstrated substantial improvement in the KCCQ-OS at 1 month (mean between-group difference 15.9 points; 95% confidence interval [CI]: 12.3 to 19.5 points), with only slight attenuation of this benefit through 24 months (mean between-group difference 12.8 points; 95% CI: 7.5 to 18.2 points). At 24 months, 36.4% of TMVr patients were alive with a moderately large (≥10-point) improvement versus 16.6% of standard care patients (p < 0.001), for a number needed to treat of 5.1 patients (95% CI: 3.6 to 8.7 patients). TMVr patients also reported better generic health status at each timepoint (24-month mean difference in SF-36 summary scores: physical 3.6 points; 95% CI: 1.4 to 5.8 points; mental 3.6 points; 95% CI: 0.8 to 6.4 points).
Among patients with symptomatic HF and 3+ to 4+ secondary MR receiving maximally-tolerated medical therapy, edge-to-edge TMVr resulted in substantial early and sustained health status improvement compared with medical therapy alone. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial] [COAPT]; NCT01626079).
在 COAPT（经导管二尖瓣修复术治疗有功能性二尖瓣反流的心力衰竭患者的心血管结局评估）试验中，对于接受最大耐受药物治疗的有症状心力衰竭和 3+至 4+继发性二尖瓣反流（MR）的患者，经导管二尖瓣修复术（TMVr）可降低心力衰竭（HF）住院率并提高生存率。鉴于这些患者的年龄较大和合并症较多，改善健康状况也是一个重要的治疗目标。
本研究旨在了解接受 TMVr 与标准治疗的 3+至 4+继发性 MR 心力衰竭患者的健康状况结果。
COAPT 试验将 302 名有心力衰竭和 3+至 4+继发性 MR 的患者随机分为 TMVr 组（n=302）或标准治疗组（n=312）。在基线时以及 1、6、12 和 24 个月时使用堪萨斯城心肌病问卷（KCCQ）和 SF-36 健康状况调查评估健康状况。主要健康状况终点是 KCCQ 总综合评分（KCCQ-OS；范围 0 至 100；越高越好；最小临床重要差异为 5 分）。
在基线时，患者的健康状况明显受损（平均 KCCQ-OS 为 52.4±23.0）。虽然标准治疗组的健康状况随时间无变化，但随机接受 TMVr 的患者在 1 个月时 KCCQ-OS 显著改善（组间平均差异 15.9 分；95%置信区间[CI]：12.3 至 19.5 分），在 24 个月时仅有轻微衰减（组间平均差异 12.8 分；95%CI：7.5 至 18.2 分）。在 24 个月时，36.4%的 TMVr 患者存活且有中度较大（≥10 分）改善，而标准治疗组为 16.6%（p<0.001），治疗人数为 5.1 人（95%CI：3.6 至 8.7 人）。TMVr 患者在每个时间点也报告了更好的一般健康状况（24 个月时 SF-36 综合评分的平均差异：身体 3.6 分；95%CI：1.4 至 5.8 分；精神 3.6 分；95%CI：0.8 至 6.4 分）。
在接受最大耐受药物治疗的有症状心力衰竭和 3+至 4+继发性 MR 的患者中，与单独药物治疗相比，边缘到边缘的 TMVr 可带来早期和持续的健康状况显著改善。（经导管二尖瓣修复术治疗有功能性二尖瓣反流的心力衰竭患者的心血管结局评估[COAPT 试验] [COAPT]；NCT01626079）。
