Eligibility to COAPT trial in the daily practice: a real-world experience

ABSTRACT Background The COAPT Trial was the first ever to demonstrate a survival benefit in treating functional mitral regurgitation (FMR). That was achieved through transcatheter mitral repair in selected patient. The exact proportion of patients fulfilling COAPT selection criteria in the real-world is unknown. Objectives to assess the applicability of COAPT criteria in real-world and its impact on patients’ survival. Methods We assessed the clinical data and follow-up results of all consecutive patients admitted for FMR at our Department between January 2016 and May 2021 according to COAPT eligibility. COAPT eligibility was retrospectively assessed by a cardiac surgeon and a cardiologist. Results Among 394 patients, 56 (14%) were COAPT eligible. The most frequent reasons for exclusion were MR<=2 (22%), LVEF <20% or >50% (19%), and non-optimized GDMT (21.3%). Among NON-COAPT patients, weighted 4-year survival was higher in patients who received MitraClip compared to those who were left in optimized medical therapy (91.5% (CI: [0.864, 0.96] vs 71.8 % (CI = [0.509, 0.926]) respectively, p=0.027) Conclusions Only a minority (14%) of real-world patients with FMR referred to a tertiary hospital fulfilled the COAPT selection criteria. Among NON-COAPT patients, weighted 4-year survival was higher in patients who received MitraClip compared to those who were left in optimized medical therapy (91.5% (CI: [0.864, 0.96] vs 71.8 % (CI = [0.509, 0.926]) respectively, p=0.027) Condensed Abstract In the present real-life single center experience, only a small proportion of patients with functional mitral regurgitation were COAPT-like. Non-COAPT like patients treated with MitraClip experienced improved survival compared to those left in medical therapy and similar survival compared to patients treated with MitraClip fulfilling COAPT criteria. While these findings require further validation, the numerous patients currently referred to percutaneous repair outside the COAPT criteria should not be denied intervention but should receive a tailored Heart-Team evaluation. Further refinement of patients selection for transcatheter mitral valve repair and longer follow-up remain necessary. Key messages What is already known about this subject? It is established the efficacy of TEER in case of FMR and the results form the highly selective COAPT trial. What does this study add? This is the first article that prove the applicability of COAPT in real practice and shows the good outcomes also in patients excluded by the trial. How might this impact on clinical practice? This may help the operator not to exclude patients with anatomy and clinical features considered not fit from one of the most important trials in the last 10 years on TEER and medical therapy.