Non -inferiority, randomized and multicenter clinical trial to compare the efficacy and safety of Angiolite vs EES. Published at Eurointervention, July 2019.
DESCRIPTION
Device
Angiolite
Number of patients
223
Follow up
24-month
Type of lesions
De novo coronary lesions
OUTCOMES
ANGIOLITE trial achieves the primary endpoint demostrating the non-inferiority in-stent LLL*
*QCA at 6-month, p value of non-inferiority = 0.002
0.04 mm VS 0.08 mm
Angiolite shows a good clinical performance with comparable clinical outcomes between the two groups at 2 years follow up
J. Moreu et. al. EuroIntervention Dec 2019;15:e1081-e1089
CONCLUSIONS
“Angiolite is among the best of the new DES generation”
In conclusion, this first randomized trial with Angiolite, novel thin-strut, cobalt-chromium SES with a durable fluoro-acrylate-based biostable polymer found it to be non-inferior to the gold standard second generation EES in terms of angiographic parameters of restenosis. From the clinical point of view, the number of events at 2 years was very low in both groups, reflecting good clinical performance of angiolite.
This trial demonstrates similar anti-restenotic efficacy at mid-term follow-up of the Angiolite®SES vs. EES. Clinical endpoints were comparable between groups at 2-year follow-up.
The publication of ANGIOLITE Trial at 2 years is available here.
MAIN INVESTIGATOR
Dr J. Moreu Burgos
Hospital Virgen de la Salud (Toledo, SPA)
