How the COAPT trial affected the selection of patients with secondary mitral regurgitation undergoing transcatheter edge-to-edge repair: insights from the GIOTTO registry

IF 3.5 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS American heart journal Pub Date : 2025-05-01 Epub Date: 2025-01-27 DOI:10.1016/j.ahj.2025.01.013

Cesare Baldi MD , Marco Di Maio MD, PhD , Luca Esposito MD , Michele Bellino MD , Angelo Silverio MD, PhD , Marianna Adamo MD, PhD , Antonio Popolo Rubbio MD , Francesco De Felice MD , Arturo Giordano MD , Carmelo Grasso MD , Paolo Denti MD , Cosmo Godino MD , Federico De Marco MD, PhD , Fausto Castriota MD , Ida Monteforte MD , Annalisa Mongiardo MD , Anna Sonia Petronio MD, PhD , Gabriele Crimi MD , Emmanuel Villa MD , Antonio L. Bartorelli MD, PhD , Francesco Bedogni MD

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Abstract

Background

The impact of the COAPT results on clinical practice has not yet been investigated in large real-world cohort study. The aim of the study is to evaluate the potential impact of the COAPT trial by analyzing the temporal trends of baseline characteristics and outcome of secondary mitral regurgitation (SMR) patients undergoing MitraClip (MC) included in the GIOTTO registry.

Methods

The study population was divided into 2 groups, considering the enrolment before or after the COAPT publication. Temporal trend analyses were performed to evaluate the changes in baseline patients’ characteristics and clinical outcome over time, and whether the COAPT publication influenced these changes. The outcome measure was the composite of hospitalization for heart failure (HF) and all-cause death at 1 year.

Results

The analysis included 1184 consecutive SMR patients treated with MC at 19 Italian centres between January 2016 and March 2020, 809 (68.3%) in the pre-COAPT group and 375 (31.7%) in the post-COAPT group. Temporal trend analyses showed a decreasing trend for New York Heart Association (NYHA) class (P = .003), hemoglobin (P = .014), and a significant upward trend for left ventricular ejection fraction (P < .001) and peripheral arterial disease (PAD, P = .046). The publication of the COAPT trial impacted only on NYHA trend. Nonsignificant differences in the composite outcome were observed between groups (P = .086).

Conclusions

The selection process of SMR patients undergoing MC changed over time, with a significant impact of the COAPT publication mainly on the trend of NYHA class. At 1-year, patients in the post-COAPT group showed a nonsignificant reduction in the incidence of hospitalization for HF and all-cause death.

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COAPT试验如何影响继发性二尖瓣返流患者接受经导管边缘到边缘修复的选择：来自GIOTTO Registry的见解。

背景：COAPT结果对临床实践的影响尚未在大型现实世界队列研究中进行调查。本研究的目的是通过分析GIOTTO注册中接受MitraClip （MC）治疗的继发性二尖瓣返流（SMR）患者的基线特征和结局的时间趋势，来评估COAPT试验的潜在影响。方法：根据COAPT发表前后的入组情况，将研究人群分为两组。进行时间趋势分析，以评估基线患者特征和临床结果随时间的变化，以及COAPT的发表是否影响了这些变化。结果测量是1年内因心力衰竭（HF）住院和全因死亡的综合结果。结果：该分析包括2016年1月至2020年3月期间在意大利19个中心接受MC治疗的1184例连续SMR患者，其中coapt前组809例（68.3%），coapt后组375例（31.7%）。时间趋势分析显示，纽约心脏协会（NYHA）分级（p=0.003）、血红蛋白（p=0.014）呈下降趋势，左室射血分数呈显著上升趋势(p)。结论：SMR患者接受MC的选择过程随时间而改变，COAPT发表的显著影响主要是NYHA分级的趋势。1年后，coapt后组患者HF住院率和全因死亡发生率无显著降低。

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来源期刊

American heart journal 医学-心血管系统

CiteScore

8.20

自引率

2.10%

发文量

214

审稿时长

38 days

期刊介绍： The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.