BACKGROUND In the COAPT trial, transcatheter mitral valve repair (TMVr) with the MitraClip rapidly improved health status and reduced the long-term risks of death and heart failure (HF) hospitalization in patients with HF and severe secondary mitral regurgitation (SMR) who remained symptomatic despite maximally-tolerated guideline directed medical therapy (GDMT). OBJECTIVE To examine if early health status changes were associated with long-term clinical outcomes in the COAPT population. METHODS We evaluated the association between change in health status (KCCQ-OS) from baseline to 1 month and the composite rate of death or HF hospitalization between 1 month and 2 years in the COAPT trial and tested whether treatment (TMVr or GDMT alone) modified this association. RESULTS Among 551 patients with HF and severe SMR who were alive at 1 month, those randomized to TMVr were more likely than GDMT alone to achieve a ≥10-point improvement in KCCQ-OS from baseline to 1 month (TMVr 58%, GDMT alone 26%). Early improvement in KCCQ-OS was inversely associated with the risk of death or HF hospitalization between 1 month and 2 years (p<0.001). When analyzed as a continuous variable, a 10-point increase in KCCQ-OS was associated with a 14% lower risk of death or HF hospitalization (HR 0.86, 95% CI 0.81-0.92, p<0.001), with no significant interaction with treatment group (pinteraction=0.17). After adjusting for demographic and clinical factors, the association between change in KCCQ-OS and outcomes was strengthened (HR 0.79, 95% CI 0.73-0.86, p<0.001). CONCLUSION In patients with HF and severe SMR, a short-term change in disease-specific health status was strongly associated with the subsequent long-term risk of death or HF hospitalization. These findings reinforce the prognostic utility of serial KCCQ-OS assessments to identify patients at risk for poor long-term clinical outcomes in this population.

中文翻译：

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心力衰竭和二尖瓣关闭不全患者的健康状况变化和结果：来自 COAPT

背景在 COAPT 试验中，使用 MitraClip 的经导管二尖瓣修复术 (TMVr) 迅速改善了健康状况，并降低了心衰和严重继发性二尖瓣关闭不全 (SMR) 患者的长期死亡和心力衰竭 (HF) 住院风险。尽管有最大耐受指南指导的药物治疗 (GDMT)，但仍有症状。目的 检验早期健康状况变化是否与 COAPT 人群的长期临床结果相关。方法 我们评估了 COAPT 试验中从基线到 1 个月的健康状况变化 (KCCQ-OS) 与 1 个月到 2 年间死亡或 HF 住院的复合率之间的关联，并测试了治疗（单独的 TMVr 或 GDMT）是否改变这个协会。结果 在 551 例 1 个月时存活的 HF 和重度 SMR 患者中，从基线到 1 个月，随机分配到 TMVr 的患者比单独的 GDMT 更有可能在 KCCQ-OS 方面实现≥10 分的改善（TMVr 58%，单独的 GDMT 26%）。KCCQ-OS 的早期改善与 1 个月至 2 年之间的死亡或心衰住院风险呈负相关（p<0.001）。当作为连续变量进行分析时，KCCQ-OS 增加 10 点与死亡或心衰住院风险降低 14% 相关（HR 0.86，95% CI 0.81-0.92，p<0.001），与治疗组（pinteraction=0.17）。在调整人口统计学和临床​​因素后，KCCQ-OS 变化与结果之间的关联得到加强（HR 0.79，95% CI 0.73-0.86，p<0.001）。结论 在 HF 和严重 SMR 患者中，特定疾病健康状况的短期变化与随后的长期死亡或心衰住院风险密切相关。这些发现加强了连续 KCCQ-OS 评估的预后效用，以识别该人群中存在长期临床结果不佳风险的患者。