Abstract 4541: Long Term Results of Bevacizumab Eluting Stent: First in Man Application of a Stent Dedicated to the Inhibition of Plaque Neovascularization
Background: Endothelial growth factor is the main mediator of neovascularization. Bevacizumab is a monoclonal antibody specific for vascular endothelial growth factor. In this study we present the long-term results of the safety and efficacy study of the first-in-man application of bevacizumab-eluting stent.
Methods: Patients with acute coronary syndromes and ≥2 angiographically significant coronary artery stenoses were included in the study. The culprit lesions were successfully treated. The non-culprit lesions to be included were ≤20 mm in length, producing a significant stenosis (≥50%, in vessels with reference diameter ≥2.25mm). Local delivery of bevacizumab was accomplished via BiodivYsio stents. Patients were discharged under aspirin and clopidogrel for 24 months. All patients were scheduled for angiographic follow-up at 24 months and clinical follow-up at 36 months. Intravascular ultrasound of the target vessel was performed immediately after the procedure and at 24 months.
Results: Twenty five consecutive patents were included. All stents were successfully delivered without any complication. During a follow-up period of 37.16±5.22 months there were no adverse cardiac events such as death, myocardial infarction and target vessel revascularization. Angiographic and intravascular ultrasound follow-up were performed at 22.25±2.84 months. Stent thrombosis was not observed. Angiographic and intravascular ultrasound follow-up did not reveal any restenosis (50% vessel narrowing) in any target vessel. Stent malapposition was not observed in any patient. In-stent late loss was 0.15±0.9 mm, and in-lesion late loss was 0.16±0.03 mm. Mean neointimal hyperplasia in stented segments as measured with intravascular ultrasound was 0.82±0.29 mm.
Conclusions: The implantation of bevacizumab-eluting stents in human coronary arteries is feasible and safe and elicits minimal neointimal proliferation. Moreover, there were no late adverse cardiac events. Futher randomized trials need to be performed.