title: Safety and efficacy of the cobalt chromium PRO-Kinetik coronary stent system: results of the MULTIBENE study.
abstract: BACKGROUND
  The aim of this MULTIBENE study was to evaluate the safety and efficacy of the silicon carbide coated cobalt chromium PRO-Kinetik coronary stent system in patients with single de novo coronary lesions.
  
  
  METHODS
  This prospective international multicenter study included 202 patients at 10 European sites. Analysis was performed on the per protocol population of 197 patients. Patients were followed until 12 months, a subset of patients (n=72) underwent additional coronary angiography at 6 months. Primary endpoint was 6-months rate of target vessel failure (TVF), defined as a composite of cardiac death, myocardial infarction and target vessel revascularization (TVR).
  
  
  RESULTS
  At 6 months, rate of TVF was 10.9% and rate of major adverse cardiac events, a composite of cardiac death, MI, target lesion revascularization (TLR) and coronary artery bypass graft, was 11.4%, both being mainly attributed to TVR respective TLR. No cardiac death or stent thrombosis occurred. In-segment late lumen loss was 0.66±0.61mm and binary restenosis was 20.8%, as determined by core laboratory in the angiographic subgroup.
  
  
  CONCLUSIONS
  Based on these data, the PRO-Kinetik coronary stent system was found to be safe and effective.
authors.affiliation: ZNA Middelheim, Department Interventional Cardiology, Antwerpen 2020, Belgium. paul.vermeersch@zna.be
authors.forename: Paul
authors.initials: P
authors.lastname: Vermeersch
authors.forename: Yolande
authors.initials: Y
authors.lastname: Appelman
authors.forename: Dieter
authors.initials: D
authors.lastname: Horstkotte
authors.forename: Gert
authors.initials: G
authors.lastname: Richardt
authors.forename: Jean
authors.initials: J
authors.lastname: Boland
authors.forename: Jacques
authors.initials: J
authors.lastname: Lalmand
authors.forename: Patrick
authors.initials: P
authors.lastname: Coussement
authors.forename: Marc
authors.initials: M
authors.lastname: Castadot
authors.forename: Luc
authors.initials: L
authors.lastname: Janssens
authors.forename: Pierfrancesco
authors.initials: P
authors.lastname: Agostoni
authors.forename: Ian
authors.initials: I
authors.lastname: Buysschaert
authors.forename: Maarten J
authors.initials: MJ
authors.lastname: Suttorp
mesh_terms: D000328:Adult; D000368:Aged; D017554:Carbon Compounds, Inorganic / Q000009:adverse effects; D002857:Chromium / Q000009:adverse effects / Q000627:therapeutic use*; D003035:Cobalt / Q000009:adverse effects / Q000627:therapeutic use*; D003324:Coronary Artery Disease / Q000628:therapy*; D023903:Coronary Restenosis / Q000628:therapy*; D003643:Death; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000150:complications; D062645:Percutaneous Coronary Intervention; D011446:Prospective Studies; D017655:Silicon Compounds / Q000009:adverse effects; D015607:Stents; D016896:Treatment Outcome
chemical_list: D017554:Carbon Compounds, Inorganic; D017655:Silicon Compounds; D002857:Chromium; D003035:Cobalt; C022088:silicon carbide