title: First-in-man study with bevacizumab-eluting stent: a new approach for the inhibition of atheromatic plaque neovascularisation.
abstract: OBJECTIVE
  Neovascularisation is mainly mediated by vascular endothelial growth factor (VEGF). Bevacizumab is a monoclonal antibody specific for VEGF. We assessed the safety of a bevacizumab-eluting stent, a dedicated stent for inhibition of plaque neovascularisation.
  
  
  RESULTS
  Patients with acute coronary syndromes and >2 significant coronary artery stenoses were included in the study. The culprit lesions should be successfully treated percutaneously. The targeted non-culprit lesions were <20 mm in length, producing significant stenosis (>50%). Local delivery of bevacizumab was accomplished via BiodivYsio stents which bear a phosphorylcholine coating that adsorbs the drug. Patients were discharged under aspirin and clopidogrel for six months. All patients were scheduled for clinical and angiographic follow-up at six months, and intravascular ultrasound (IVUS) imaging of the target vessel immediately after the procedure and at six months. Twenty consecutive patients were included. All stents were successfully delivered. During a follow-up period of 9.23+/-0.87 months there were no adverse cardiac events, including death, myocardial infarction and target vessel revascularisation. Angiographic and IVUS follow-up was performed in all patients. Acute, subacute or late thrombosis was not observed. Angiographic restenosis was not observed in any target vessel. In-stent late loss was 0.2+/-0.1 mm, and in-lesion late loss was 0.2+/-0.1 mm. Mean neointimal hyperplasia area in stented segments was 0.8+/-0.5 mm2 (12.4+/-7.7%) by IVUS.
  
  
  CONCLUSIONS
  The implantation of bevacizumab-eluting stents in human coronary arteries seems safe and elicits minimal neointimal hyperplasia. This new approach for high-risk plaque stabilisation through inhibition of plaque neovascularisation requires further investigation through placebo-controlled trials.
authors.affiliation: First Department of Cardiology, Hippokration Hospital, Athens, Greece.
authors.forename: Christodoulos
authors.initials: C
authors.lastname: Stefanadis
authors.forename: Konstantinos
authors.initials: K
authors.lastname: Toutouzas
authors.forename: Eleftherios
authors.initials: E
authors.lastname: Tsiamis
authors.forename: Manolis
authors.initials: M
authors.lastname: Vavuranakis
authors.forename: Elli
authors.initials: E
authors.lastname: Stefanadi
authors.forename: Nicholas
authors.initials: N
authors.lastname: Kipshidze