First human experience with angiopeptin-eluting stent: A quantitative coronary angiography and three-dimensional intravascular ultrasound study

Angiopeptin has been shown to reduce in‐stent restenosis in various animal models. Meanwhile, BiodivYsio DD phosphorylcholine (PC)‐coated stent provides a platform for local delivery of antiproliferative agents to the coronary artery. We studied the feasibility, safety, and impact on tissue growth of angiopeptin‐eluting BiodivYsio DD PC‐coated stents in human native de novo coronary lesions. We enrolled 14 patients (16 lesions) who underwent intravascular ultrasound (IVUS)‐guided angiopeptin‐eluting stent implantation in native coronary arteries between 3.0 and 4.0 mm in diameter with lesion length ≤ 18 mm. We successfully implanted 13 stents loaded with 22 μg of angiopeptin and three stents with 126 μg of angiopeptin. No major adverse cardiac events or target vessel failure occurred at 1‐year clinical follow‐up. All patients underwent 6‐month angiographic and volumetric IVUS follow‐up. In‐stent late loss was 0.46 ± 0.32 mm in the low‐dose group and 0.26 ± 0.14 mm in the high‐dose group. Binary restenosis rate was 0%. Follow‐up percentage neointimal hyperplasia by IVUS was 18.4% ± 22.5% for the low‐dose group and 10.2% ± 5.8% for the high‐dose group, respectively. There were no edge effect and late stent malapposition. Angiopeptin‐eluting BiodivYsio DD PC stent appears feasible and safe in treating native de novo coronary lesions with modest degree of neointimal hyperplasia. © 2005 Wiley‐Liss, Inc.