The ANCHOR study evaluating 3- and 6-month optical coherence tomographic (OCT) surveillance following percutaneous coronary intervention with the cobalt chromium Angiolite sirolimus-eluting stent system was published by Dr. Rishi Puri, Quebec Heart and Lung Institute (IUCPQ), UL, Canada et al online ahead of print in Catheterization and Cardiovascular Interventions.
Using quantitative OCT analyses, the investigators explored the healing characteristics of the Angiolite device at 3 and 6 months postimplantation. The Angiolite stent was successfully implanted in 103 patients without periprocedural complications. At 3 and 6 months follow-up, OCT strut coverage was evident in 86.3% and 83.3% of struts, mean neointimal thickness was 73.7 ± 46.5 μm and 73.9 ± 54.3 μm, mean neointimal area obstruction of 5.8% ± 10.3% and 4.4% ± 11.3%, and ISA rates were 1.3% ± 7.3% and 1.1% ± 6.2%, respectively. In-stent LLL at 6 months was 0.07 ± 0.37 mm, with a binary in-stent angiographic restenosis rate of 0% without any stent thrombosis, myocardial infarction, or cardiovascular death, with one patient undergoing ischemia-driven target lesion revascularization.
As stated by PI of the ANCHOR study Dr. Josep Rodés-Cabau, “The main purpose of ANCHOR study was to confirm Angiolite’s promising efficacy and safety results obtained in preclinical models. At 6 months, the Angiolite sirolimus-eluting stent was safe and had high rates of strut coverage, modest degrees of neointimal hyperplasia, and very low rates of strut malapposition. These data, coupled with the absence of in-stent binary restenosis and a very low 6-month in-stent LLL, point toward an efficacious drug-eluting stent.”
Angiolite is a sirolimus (1,4 µg/mm2) eluting stent on a L605 CoCr platform with ultra-thin struts of 80 µm. The distal part of the catheter is coated with a proprietary durable hydrophilic coating to minimize friction and improve its trackability. Stent sizes comprise diameters from 2.0 to 4.5 mm and lengths from 9 to 39 mm. Combining extra low profile with effective proven drug eluting coating technology, it will contribute to procedure cost reduction.
The Angiolite DES is commercially available in all Europe and other markets where CE Mark approval can expedite the registration process.