Novel PARADIGM in carotid revascularisation: Prospective evaluation of All comer peRcutaneous cArotiD revascularisation in symptomatic and Increased risk asymptomatic carotid artery stenosis using CGuard(tm) MicroNet covered embolic prevention stent system.
AIMS Our aim was to determine (1) periprocedural and 30 day clinical safety and efficacy of the CGuard MicroNet covered embolic prevention carotid stent system (MN EPS) in routine use for unselected carotid stenosis (CS) patients undergoing CAS, as well as (2) feasibility of MN EPS post dilatation optimisation to minimise residual stenosis after CAS. METHODS AND RESULTS This was a non industry funded, prospective academic study in all referrals tracked symptomatic and asymptomatic CS. In asymptomatic lesions, intervention was mandated only in case of increased stroke risk CS features. There was independent neurologist evaluation before CAS, at 48 hours and 30 days. There was external source data verification, angiographic core lab, and statistical analysis. Over 11 months, 108 referrals were recommended by the NeuroVascular Team for revascularisation: 101 (51 86 years, 55 symptomatic, evolving stroke in nine) underwent 106 (100% MN EPS use) neuroprotection device assisted (46% proximal, 54% distal) CAS; CEA was performed in seven. MN EPS device success was 99.1% Angiographic diameter stenosis was reduced from 83+ 9% to 6.7+ 5% (p<0.001) No MN EPS foreshortening/elongation occurred (30 mm long was 29.82+ 0.68 mm; 40 mm long was 39.89+ 0.59 mm) The periprocedural death/major stroke/MI rate was 0% One event, with no change in NIHSS or modified Rankin Scale and no clinical sequel, was adjudicated by the clinical events committee as minor stroke (0.9% By 30 days there were no new events (0% CONCLUSIONS These increased risk consecutive patient data (1) indicate safety and efficacy of routine MN EPS use in achieving endovascular reconstruction across all comer CS lesion subsets, and (2) are consistent with MN EPS protection against cerebral events extending throughout the stent healing period.
EuroIntervention journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology