Eligibility to COAPT trial in the daily practice: a real-world experience at 4 years

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) ### Competing Interest Statement Francesco maisano Grant and/or Research Support Abbott; Medtronic; Edwards Lifesciences; Biotronik; Boston Scientific Corporation Consulting fees, Honoraria Abbott; Medtronic; Edwards Lifesciences; Swissvortex Perifect; Xeltis; Transseptal solutions; Cardiovalve Royalty Income/IP Rights Edwards Lifesciences (FMR surgical annuloplasty) ; 4Tech (tricuspid catheter interventions) ### Funding Statement no funding ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The San Raffaele Hospital Institutional Ethic Committee approved this study on mitral regurgitation and tricuspid insufficiency 125/INT/2022 and waived individual consent for this retrospective analysis I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes The data collected are available on demand