TY  - BOOK
AU  - Waksman, Ron
AU  - Weissman, Neil J
TI  - 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
SN  - 1774-024X
PY  - 2013///
KW  - *Carbon Compounds, Inorganic
KW  - *Chromium Alloys
KW  - *Coronary Stenosis/th [Therapy]
KW  - *Coronary Vessels/ra [Radiography]
KW  - *Drug-Eluting Stents
KW  - *Percutaneous Coronary Intervention/mt [Methods]
KW  - *Silicon Compounds
KW  - *Sirolimus
KW  - Aged
KW  - Coronary Angiography
KW  - Coronary Restenosis/ep [Epidemiology]
KW  - Coronary Stenosis/co [Complications]
KW  - Drug-Eluting Stents/ae [Adverse Effects]
KW  - Female
KW  - Follow-Up Studies
KW  - Humans
KW  - Hyperplasia/ep [Epidemiology]
KW  - Incidence
KW  - Male
KW  - Middle Aged
KW  - Myocardial Infarction/et [Etiology]
KW  - Myocardial Infarction/th [Therapy]
KW  - Neointima/pa [Pathology]
KW  - Percutaneous Coronary Intervention/ae [Adverse Effects]
KW  - Percutaneous Coronary Intervention/is [Instrumentation]
KW  - Prospective Studies
KW  - Treatment Outcome
KW  - MedStar Heart & Vascular Institute
KW  - Journal Article
KW  - Multicenter Study
KW  - Research Support, Non-U.S. Gov't
N2  - AIMS: 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; 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; METHODS AND 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
UR  - http://dx.doi.org/10.4244/EIJV8I9A155
ER  -