Raphaël Blanc, on behalf on the EESIS-FR study group, EESIS-FR
doi.org/10.1016/j.neurad.2024.01.078
Abstract
Background
The effect of dual antiplatelet therapy (DAPT) duration on total events in patients at high bleeding risk (HBR) after percutaneous coronary intervention (PCI) is unclear.
Objectives
This study aimed to evaluate an abbreviated (median duration, 34 days) vs prolonged (median duration, 192 days) DAPT regimen on total events in 4,579 HBR patients from the MASTER DAPT (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Standard DAPT Regimen) trial.
Introduction and Methods
eCLIPs eB is a unique device designed to retain coils and divert flow at a bifurcation aneurysm with 4 sizes to accommodate neck lengths to 12mm. French eCLIPs™ Efficacy and Safety Investigation (EESIS-FR) is an open label, prospective, historically controlled (vs. optimal performance criteria), multicentre, single-arm study trial partly funded by French HAS under its Forfait Innovation program to demonstrate safety and efficacy of eCLIPs for saccular, intracranial aneurysms, unruptured or previously ruptured (≥1 month since rupture and neurologically stable), arising at a bifurcation of Basilar Tip (BT) or Carotid Terminus (CT), with a minimal diameter of 5mm and a maximal diameter <25mm, has a neck length of ≥4mm or dome:neck ratio <2, branch artery diameters in the range of 1.5mm to 3.25mm.
Results
We report the first 60 patients (of a goal of 119) enrolled at 13 sites (opened on 26 particpating sites). Aneurysm characteristics: 26 BT, 34 CT, 15 recurrent after prior treatment, 9 previously ruptured. Aneurysm metrics are as follows (Table1):
Conclusions
EESIS-FR is the first prospective analysis of eCLIPs eB, showing in preliminary results acceptable safety and efficacy profiles. The complete results of the full cohort of 119 patients are necessary to finalize these conclusions.
