At EuroPCR (22 May–25 May, Paris, France), the 12-month results of the ANGIOLITE trial were presented for the first time by J Moreu Burgos. The randomised prospective multicentre controlled trial enrolled 223 patients and had the objective of demonstrating Angiolite drug-eluting stent (iVascular) non inferiority vs. the Xience drug-eluting stent (Abbott).
Both primary and secondary endpoints were met with statistical significance: 0.04mm late lumen loss at six months, and 5.4% target lesion failure (composite endpoint), 0.7% binary artery restenosis (intra-stent), 0.7% definite thrombosis, as well as 6.4% major adverse cardiac events at 12 months.
Six-month optical coherence tomography (OCT) results confirmed optimal struts coverage (90.8%) with only 64.3µm neointimal thickness, and very low malapposition (1.3%) despite high ratio of myocardial infarction patients.
Moreu comments: “The Angiolite drug-eluting stents demonstrates a favourable early healing profile, long term efficacy and optimised deliverability”, adding that such outcomes are “positioning it as one of the most competitive drug-eluting stents available on the market”.
Lluis Duocastella, CEO of iVascular, states: “We are happy to have those data confirming the safety and long-term efficacy of our innovative Angiolite drug-eluting stents. Further developments are on the way to continue to provide the best of technology to the patients.
According to a press release, the 24-month results of the ANGIOLITE Trial are expected to be presented at Euro PCR 2019.