A single-centre real world experience has found that the vast majority of patients with severe mitral regurgitation (MR) were not eligible for inclusion in the COAPT trial, with the most frequent reason for exclusion being that they were not on maximal guideline directed medical therapy (GDMT). Despite a better profile and improved drug regimen after discharge, non-COAPT patients who were left in GDMT had worse one-year survival than non-COAPT patients treated with Mitra Clip.
The data were presented by Eduardo Zancanaro (San Raffaele Hospital, Milan, Italy) on behalf of his fellow investigators at a moderated poster session at PCR London Valves 2019 (17–19 November, London, UK). The aim of the study was to assess the applicability of the COAPT trial in a single centre real world practice, and the overall survival of patients affected by severe MR, depending on their eligibility for entry into the COAPT trial.
In all, 292 patients referred to the cardiac surgery department at San Raffaele Hospital from January 2016 to May 2018 were retrospectively reviewed to determine whether they were eligible for COAPT; after exclusions, 186 patients with secondary MR that were refused surgery remained. Of these, 37 were judged suitable for COAPT and underwent a Mitra Clip procedure. One-year follow-up was collected through in-hospital data and/or telephone interview. Patients underwent transoesophageal echocardiogram (TEE) with multiparamteric MR assessment according to European Society of Cardiology (ESC) guidelines and heart team discussion.
Of the 149 considered ineligible, Zancanaro and colleagues found that the most common reasons for this were medical therapy that was not considered optimal (44), an ejection fraction not within the required range (31), and unsuitable anatomy (17). In the non-COAPT group, 108 underwent a Mitra Clip procedure, 11 received transmitral valve replacement (TMVR), and 30 patients proceeded with medical therapy.
Zancanaro highlighted that, among non-COAPT patients, the volume and diameter of the ventricles, and ejection fraction was “much worse among patients with Mitra Clip compared to medical therapy. On this profile, the medical therapy patients were much better.”
Investigators found no difference in outcomes between Mitra Clip non-COAPT patients and Mitra Clip COAPT-eligible patients. But added Zancanaro “there is a statistical difference between the Mitra Clip non-COAPT and the medical therapy non-COAPT. There is 90% overall survival at one year for the Mitra Clip non-COAPT group, and 83% for medical therapy non-COAPT.”