Abstract 18198: Long Term Results of a Novel Approach for the Inhibition of Plaque Neovascularization. First In Man Application of Bevacizumab Eluting Stent
Background: Bevacizumab is a monoclonal antibody specific for vascular endothelial growth factor, the most important mediator of neovascularization. Neovascularization plays an important role in the development and destabilization of the atheromatic plaque. In this study we present 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 shorter than 20 mm, 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 aspirin (indefinitely) and clopidogrel for 24 months, and were scheduled for angiographic follow-up at 24 months and clinical follow-up at 50 months. Intravascular ultrasound of the target vessel was performed immediately after the procedure and at 24 months.
Results: Twenty consecutive patents were included. All stents were successfully delivered (mean stent length 13.55±4.1 mm) and all patients were discharged without any complication. 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 at the angiographic follow-up. 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. During a follow-up period of 48.11±3.11 months there were no adverse cardiac events such as death, myocardial infarction and target vessel revascularization. There was no adverse event between the 2nd and 4th year of clinical follow-up period.
Conclusions: Non-culprit de novo lesions of patients with acute coronary syndromes can be safely treated with bevacizumab-eluting stents. These findings warrant further confirmation in larger studies.
- © 2010 by American Heart Association, Inc.