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

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 two 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=0.003), hemoglobin (p=0.014), and a significant upward trend for left ventricular ejection fraction (p<0.001) and peripheral arterial disease (PAD, p=0.046). The publication of the COAPT trial impacted only on NYHA trend. Non-significant differences in the composite outcome were observed between groups (p = 0.086).

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 non-significant reduction in the incidence of hospitalization for HF and all-cause death.