ANCHOR OCT Surveillance Study Evaluates iVascular's Angiolite Sirolimus-Eluting Stent System
July 17, 2017—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 (iVascular) was published by Rishi Puri, MD, 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 investigators noted that preclinical results of the Angiolite device were promising.
As summarized in Catheterization and Cardiovascular Interventions, a total of 103 patients with de novo coronary lesions underwent percutaneous coronary intervention with the Angiolite sirolimus-eluting stent and were randomized 1:3 into two cohorts for angiographic and OCT follow-up, with 28 and 70 patients returning for 3- or 6-month post-PCI surveillance, respectively. The primary endpoints were the 6-month rates of OCT-derived neointimal proliferation, strut coverage, and incomplete strut apposition (ISA). The secondary endpoints were 3-month OCT-derived measures of strut coverage and ISA, as well as 6-month quantitative coronary angiography–derived measures (late lumen loss [LLL], binary restenosis).
The investigators reported that the Angiolite stent was successfully implanted in all 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.
The investigators concluded that 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. Future studies are required to evaluate its efficacy in broader lesion subsets with longer follow-up, advised the investigators in Catheterization and Cardiovascular Interventions.