title: Clinical and angiographic experience with a third-generation drug-eluting Orsiro stent in the treatment of single de novo coronary artery lesions (BIOFLOW-I): a prospective, first-in-man study.
abstract: OBJECTIVE
  To report the four-month and nine-month angiographic results as well as one-year clinical follow-up from the first-in-man study with the silicon carbide and sirolimus-eluting bioabsorbable polymer (poly-L-lactic acid (PLLA) polymer) -coated cobalt-chromium Orsiro stent.
  
  
  RESULTS
  A group of 30 patients with documented myocardial ischaemia related to a single de novo coronary stenosis up to 22 mm in length, in vessels with a 2.5 to 3.5 mm reference diameter, and between >50% and <90% diameter stenosis were enrolled at two sites. The primary endpoint of the study was in-stent late lumen loss at nine months. The secondary endpoints included major adverse cardiac events (MACE) at one year defined as the composite of cardiac death, ischaemia-driven target lesion revascularisation (TLR) and target vessel myocardial infarction (MI). Procedural success was 100%. Angiographic late lumen loss was 0.12±0.19 mm and 0.05±0.22 mm at four and nine months respectively. At one-year clinical follow-up, the composite MACE was 10% with one patient who died from cardiac death and two patients who had ischaemia-driven target lesion revascularisation. There was no report of MI or stent thrombosis.
  
  
  CONCLUSIONS
  The Orsiro drug-eluting stent demonstrated potency with low rates of in-stent neointimal hyperplasia and cardiovascular events but warrants further evaluation in a larger population cohort with longer follow-up time points.
authors: Centre Hospitalier Universitaire de Caen, Avenue Côte de Nacre, Caen, Normandie, France. hamon-m@chu-caen.fr
authors: Martial
authors: M
authors: Hamon
authors: Rodica
authors: R
authors: Niculescu
authors: Dan
authors: D
authors: Deleanu
authors: Maria
authors: M
authors: Dorobantu
authors: Neil J
authors: NJ
authors: Weissman
authors: Ron
authors: R
authors: Waksman
mesh_terms: D000368:Aged; D017554:Carbon Compounds, Inorganic; D002858:Chromium Alloys; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000453:epidemiology; D023921:Coronary Stenosis / Q000150:complications / Q000628:therapy*; D003331:Coronary Vessels / Q000000981:diagnostic imaging*; D054855:Drug-Eluting Stents / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006965:Hyperplasia / Q000453:epidemiology; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000628:therapy; D058426:Neointima / Q000473:pathology; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D011446:Prospective Studies; D017655:Silicon Compounds; D020123:Sirolimus; D016896:Treatment Outcome
chemical_list: D017554:Carbon Compounds, Inorganic; D002858:Chromium Alloys; D017655:Silicon Compounds; D020123:Sirolimus; C022088:silicon carbide