Baldi Cesare, Di Maio Marco, Esposito Luca, Bellino Michele, Silverio Angelo, Adamo Marianna, Popolo Rubbio Antonio, De Felice Francesco, Giordano Arturo, Grasso Carmelo, Denti Paolo, Godino Cosmo, De Marco Federico, Castriota Fausto, Monteforte Ida, Mongiardo Annalisa, Petronio Anna Sonia, Crimi Gabriele, Villa Emmanuel, Bartorelli Antonio L, Citro Rodolfo, Galasso Gennaro, Tarantini Giuseppe, Tamburino Corrado, Bedogni Francesco
Interventional Cardiology Unit, University Hospital San Giovanni di Dio e Ruggi d'Aragona, Salerno Italy.
Interventional Cardiology Unit, University Hospital San Giovanni di Dio e Ruggi d'Aragona, Salerno Italy; Department of Medicine, Surgery and Dentistry, University of Salerno, Baronissi, Salerno, Italy.
Am Heart J. 2025 May;283:43-52. doi: 10.1016/j.ahj.2025.01.013. Epub 2025 Jan 27.
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.
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.
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).
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.
在大型真实世界队列研究中，尚未对COAPT试验结果对临床实践的影响进行调查。本研究的目的是通过分析纳入GIOTTO注册研究的接受MitraClip（MC）治疗的继发性二尖瓣反流（SMR）患者的基线特征和结局的时间趋势，评估COAPT试验的潜在影响。
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患者基线特征和临床结局随时间的变化，以及COAPT的发表是否影响了这些变化。结局指标为1年时心力衰竭（HF）住院和全因死亡的复合终点。
分析纳入了2016年1月至2020年3月期间在19个意大利中心接受MC治疗的1184例连续SMR患者，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 = .003）、血红蛋白（P = .014）呈下降趋势，左心室射血分数（P < .001）和外周动脉疾病（PAD，P = .046）呈显著上升趋势。COAPT试验的发表仅影响NYHA趋势。两组间复合结局无显著差异（P = .086）。
接受MC治疗的SMR患者的选择过程随时间发生了变化，COAPT发表的主要影响是NYHA分级趋势。1年时，COAPT后组患者HF住院和全因死亡发生率有不显著的降低。
