Twelve-Month Data Presented for iVascular's Angiolite DES
July 3, 2018—Twelve-month results from ANGIOLITE trial were presented by J. Moreu Burgos, MD, at EuroPCR 2018, which was held May 21–25 in Paris, France. The randomized, prospective, multicenter, controlled trial enrolled 223 patients with the objective of demonstrating the noninferiority of iVascular's Angiolite drug-eluting stent (DES) versus Abbott Vascular's Xience DES.
Dr. Moreu Burgos commented in the company's press release, “Angiolite DES demonstrates a favorable early healing profile, long-term efficacy, and optimized deliverability."
According to iVascular, both primary and secondary endpoints were met with statistical significance. At 6 months, late lumen loss was 0.04 mm, target lesion failure (composite endpoint) was 5.4%, binary artery restenosis (intrastent) was 0.7%, and definite thrombosis was 0.7%. At 12 months, the rate of major adverse cardiac events was 6.4%.
Optical coherence tomography results at 6 months confirmed optimal struts coverage (90.8%) with only 64.3-µm neointimal thickness and very low malapposition (1.3%), despite a high ratio of myocardial infarction patients, stated iVascular.
The company added that the data confirm the safety and long-term efficacy of the Angiolite DES. The 24-month results of the ANGIOLITE trial are expected to be presented at EuroPCR 2019.