COPD 对二尖瓣夹合术治疗继发性二尖瓣反流患者结局的影响：COAPT 试验。
Impact of COPD on Outcomes After MitraClip for Secondary Mitral Regurgitation: The COAPT Trial.
机构信息
Saint Luke's Mid America Heart Institute, Kansas City, Missouri, USA; University of Missouri-Kansas City, Kansas City, Missouri, USA.
University of Missouri-Kansas City, Kansas City, Missouri, USA.
出版信息
JACC Cardiovasc Interv. 2020 Dec 14;13(23):2795-2803. doi: 10.1016/j.jcin.2020.09.023.
OBJECTIVES
The aim of this study was to examine the relationship between chronic obstructive pulmonary disease (COPD) and outcomes after transcatheter mitral valve repair (TMVr) for severe secondary mitral regurgitation.
BACKGROUND
TMVr with the MitraClip improves clinical and health-status outcomes in patients with heart failure and severe (3+ to 4+) secondary mitral regurgitation. Whether these benefits are modified by COPD is unknown.
METHODS
COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) was an open-label, multicenter, randomized trial of TMVr plus guideline-directed medical therapy (GDMT) versus GDMT alone. Patients on corticosteroids or continuous oxygen were excluded. Multivariable models were used to examine the associations of COPD with mortality, heart failure hospitalization (HFH), and health status and to test whether COPD modified the benefit of TMVr compared with GDMT.
RESULTS
Among 614 patients, 143 (23.2%) had COPD. Among patients treated with TMVr, unadjusted analyses demonstrated increased 2-year mortality in those with COPD (hazard ratio [HR]: 2.08; 95% confidence interval [CI]: 1.33 to 3.26), but this association was attenuated after risk adjustment (adjusted HR: 1.48; 95% CI: 0.87 to 2.52). Although TMVr led to reduced 2-year mortality among patients without COPD (adjusted HR: 0.47; 95% CI: 0.33 to 0.67), for patients with COPD, 2-year all-cause mortality was similar after TMVr versus GDMT alone (adjusted HR: 0.94; 95% CI: 0.54 to 1.65; p = 0.04), findings that reflect offsetting effects on cardiovascular and noncardiovascular mortality. In contrast, TMVr reduced HFH (adjusted HR: 0.48 [95% CI: 0.28 to 0.83] vs. 0.46 [95% CI: 0.34 to 0.63]; p = 0.89) and improved both generic and disease-specific health status to a similar extent compared with GDMT alone in patients with and without COPD (p >0.30 for all scales).
CONCLUSIONS
In the COAPT trial, COPD was associated with attenuation of the survival benefit of TMVr versus GDMT compared with patients without COPD. However, the benefits of TMVr on both HFH and health status were similar regardless of COPD. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial] [COAPT]; NCT01626079).
目的
本研究旨在探讨慢性阻塞性肺疾病（COPD）与严重二尖瓣反流经导管二尖瓣修复术（TMVr）后结局之间的关系。
背景
对于心力衰竭和严重（3+至 4+）二尖瓣反流患者，TMVr 联合 MitraClip 可改善临床和健康状况结局。尚不清楚 COPD 是否会改变这些获益。
方法
COAPT（功能性二尖瓣反流心力衰竭患者经皮 MitraClip 治疗的心血管结局评估）是一项 TMVr 加指南指导的药物治疗（GDMT）与 GDMT 单用的开放性、多中心、随机试验。排除接受皮质激素或持续吸氧的患者。采用多变量模型来检验 COPD 与死亡率、心力衰竭住院（HFH）和健康状况之间的关联，并检验 COPD 是否改变了 TMVr 相对于 GDMT 的获益。
结果
在 614 例患者中，143 例（23.2%）患有 COPD。在接受 TMVr 治疗的患者中，未经校正的分析显示 COPD 患者的 2 年死亡率增加（风险比[HR]：2.08；95%置信区间[CI]：1.33 至 3.26），但风险调整后这种关联减弱（校正 HR：1.48；95%CI：0.87 至 2.52）。尽管 TMVr 可降低无 COPD 患者的 2 年死亡率（校正 HR：0.47；95%CI：0.33 至 0.67），但对于 COPD 患者，TMVr 与 GDMT 单用相比，2 年全因死亡率相似（校正 HR：0.94；95%CI：0.54 至 1.65；p=0.04），这反映了对心血管和非心血管死亡率的相互抵消作用。相比之下，TMVr 降低了 HFH（校正 HR：0.48 [95%CI：0.28 至 0.83] vs. 0.46 [95%CI：0.34 至 0.63]；p=0.89），并改善了有无 COPD 患者的一般健康状况和特定疾病健康状况，与 GDMT 单用相比具有相似程度的改善（所有量表 p＞0.30）。
结论
在 COAPT 试验中，与无 COPD 患者相比，COPD 与 TMVr 相对于 GDMT 的生存获益减弱相关。然而，TMVr 在 HFH 和健康状况方面的获益无论 COPD 情况如何都相似。（功能性二尖瓣反流心力衰竭患者经皮 MitraClip 治疗的心血管结局评估[COAPT 试验] [COAPT]；NCT01626079）。
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