Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, Texas.
Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, Texas.
J Am Coll Cardiol. 2020 Sep 1;76(9):1007-1014. doi: 10.1016/j.jacc.2020.07.010.
Transcatheter mitral valve repair with the MitraClip results in marked clinical improvement in some but not all patients with secondary mitral regurgitation (MR) and heart failure (HF).
This study sought to evaluate the clinical predictors of a major response to treatment in the COAPT trial.
Patients with HF and severe MR who were symptomatic on maximally tolerated guideline-directed medical therapy (GDMT) were randomly assigned to MitraClip plus GDMT or GDMT alone. Super-responders were defined as those alive without HF hospitalization and with ≥20-point improvement in the Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) score at 12 months. Responders were defined as those alive without HF hospitalization and with a 5 to <20-point KCCQ-OS improvement at 12 months. Nonresponders were those who either died, were hospitalized for HF, or had <5-point improvement in KCCQ-OS at 12 months.
Among 614 enrolled patients, 41 (6.7%) had missing KCCQ-OS data and could not be classified. At 12 months, there were 79 super-responders (27.2%), 55 responders (19.0%), and 156 nonresponders (53.8%) in the MitraClip arm compared with 29 super-responders (10.2%), 46 responders (16.3%), and 208 nonresponders (73.5%) in the GDMT-alone arm (overall p < 0.0001). Independent baseline predictors of clinical responder status were lower serum creatinine and KCCQ-OS scores and treatment assignment to MitraClip. MR grade and estimated right ventricular systolic pressure at 30 days were improved to a greater degree in super-responders and responders but not in nonresponders.
Baseline predictors of clinical super-responders in patients with HF and severe secondary MR in the COAPT trial were lower serum creatinine, KCCQ-OS score and MitraClip treatment. Improved MR severity and reduced right ventricular systolic pressure at 30 days are associated with a long-term favorable clinical response after transcatheter mitral valve repair. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [COAPT]; NCT01626079).
经导管二尖瓣修复术联合使用 MitraClip 可显著改善部分而非所有因继发性二尖瓣反流（MR）和心力衰竭（HF）而接受治疗的患者的临床状况。
本研究旨在评估 COAPT 试验中治疗主要反应的临床预测因素。
HF 合并严重 MR 的患者，在最大耐受指南指导的药物治疗（GDMT）下仍存在症状，随机分为 MitraClip 联合 GDMT 或 GDMT 单独治疗组。超级反应者定义为：在 12 个月时无 HF 住院且堪萨斯城心肌病问卷整体评分（KCCQ-OS）改善≥20 分；反应者定义为：在 12 个月时无 HF 住院且 KCCQ-OS 改善 5-<20 分；无反应者定义为：12 个月时死亡、HF 住院或 KCCQ-OS 改善<5 分。
在 614 名入组患者中，有 41 名（6.7%）患者的 KCCQ-OS 数据缺失，无法分类。在 12 个月时，MitraClip 组中有 79 名超级反应者（27.2%）、55 名反应者（19.0%）和 156 名无反应者（53.8%），而 GDMT 组中有 29 名超级反应者（10.2%）、46 名反应者（16.3%）和 208 名无反应者（73.5%）（总体 p<0.0001）。临床反应者状态的独立基线预测因素是血清肌酐和 KCCQ-OS 评分较低，以及接受 MitraClip 治疗。超级反应者和反应者的 MR 分级和 30 天估计右心室收缩压改善程度更大，但无反应者则没有。
在 COAPT 试验中，HF 合并严重继发性 MR 患者的临床超级反应者的基线预测因素为血清肌酐、KCCQ-OS 评分和 MitraClip 治疗。30 天时 MR 严重程度和右心室收缩压降低与经导管二尖瓣修复后长期有利的临床反应相关。
