title: Clinical, angiographic, and intravascular ultrasound results of the VestSaync II trial.
abstract: OBJECTIVE
  We sought to assess the long term efficacy of the novel VESTAsync™ Eluting Stent (VES) combining a Cro-Co platform with a nanothin-microporous hydroxyapatite surface coating impregnated with a polymer-free low-dose of Sirolimus (55 μg).
  
  
  METHODS
  The Vestasync II trial was a randomized (2:1), double-blinded, multicenter comparison of the VES to its platform, the Gen X stent, with microporous hydroxyapatite surface coating without sirolimus. Patients were eligible if they presented de novo lesions in native coronary arteries with 3.0-3.5 mm diameter and ≤ 14 mm in length. Primary endpoint was 8-month in-stent late loss and % of stent obstruction. Lifelong aspirin and 6-month clopidogrel were prescribed to all patients.
  
  
  RESULTS
  Seventy-five patients were enrolled (VES = 50 pts). Baseline characteristics included mean age of 58 years and 29% of diabetics. Reference vessel diameter and lesion length were 2.8 ± 0.4 mm and 13.0 ± 2.0 mm, respectively. In-stent late loss (0.39 ± 0.20 vs. 0.74 ± 0.52, P = 0.03) and % of neointima hyperplasia (9.3 ± 6.6% vs. 17.6 ± 9.4%, P = 0.0016) were significantly reduced in the VES cohort. Up to 1 year, there was a single case of myocardial infarction and one target lesion revascularization (TLR) (2%) in the VES group while in the control cohort there were one TLR (4%) and one cardiac death (4%).
  
  
  CONCLUSIONS
  The VestSync II trial is a proof-of-concept study and demonstrates the sustained efficacy of this novel polymer-free sirolimus drug-eluting stents. A larger trial, with more complex lesions, clinical endpoints and longer FU period is warranted. © 2013 Wiley Periodicals, Inc.
authors: Department of Invasive Cardiology, Instituto Dante Pazzanese de Cardiologia, São Paulo, Brasil.
authors: J Ribamar
authors: JR
authors: Costa
authors: Breno A
authors: BA
authors: Oliveira
authors: Alexandre
authors: A
authors: Abizaid
authors: Ricardo
authors: R
authors: Costa
authors: Marco
authors: M
authors: Perin
authors: Andréa
authors: A
authors: Abizaid
authors: Daniel
authors: D
authors: Chamié
authors: Luiz
authors: L
authors: Fernando Tanajura
authors: Amanda
authors: A
authors: Sousa
authors: J Eduardo M R
authors: JE
authors: Sousa
mesh_terms: D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography / Q000379:methods*; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000601:surgery*; D004311:Double-Blind Method; D054855:Drug-Eluting Stents; D004562:Electrocardiography; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D011446:Prospective Studies; D011474:Prosthesis Design; D015607:Stents; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional / Q000379:methods*
chemical_list: D020099:Coated Materials, Biocompatible
keywords: drug-eluting stent; hydroxyapatite; polymer-free system; sirolimus