Abstract 3133: Firts-in Man Study with Bevacizumab-Eluting Stent: A New Approach for the Inhibition of Plaque Neovascularization.
Introduction: Neovascularization is mainly mediated by vascular endothelial growth factor. Bevacizumab is a monoclonal antibody specific for this growth factor. In this study we investigated the safety and efficacy of bevacizumab-eluting stent, a dedicated stent for inhibition of plaque neovascularization.
Methods: Patients with acute coronary syndromes and ≥ 2 angiographically significant coronary artery stenoses were included in the study. The culprit lesions were successfully treated percutaneously. The non-culprit lesions were less than 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, which bear a phosphorylcholine coating that adsorbs the drug with a “sponge-like” mechanism. Patients were discharged under drug treatment including aspirin (indefinitely) and clopidogrel for 12 months. All patients were scheduled for clinical and angiographic follow-up at 12 months. Intravascular ultrasound of the target vessel was performed immediately after the procedure and at 12 months.
Results: Twenty consecutive patients were included. All stents were successfully delivered (mean stent length 13.4±3.8mm) and all patients were discharged without any complication. During a follow-up period of 11.45 ± 0.73 months there were no adverse cardiac event such as death, myocardial infarction and target vessel revascularization. Angiographic and intravascular ultrasound follow-up were performed in all patients. Acute, subacute or late 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±0.09 mm. Mean neointimal hyperplasia area in stented segments as measured with intravascular ultrasound was 0.7±0.39 mm2.
Conclusions: The implantation of bevacizumab-eluting stents in human coronary arteries is feasible and safe and elicits minimal neointimal proliferation. Additional placebo-controlled trials are required to confirm these promising results.