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.

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Citation: Eurointervention. 8(9):1006-11, 2013 Jan 22.PMID: 23339805Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal Article | Multicenter Study | Research Support, Non-U.S. Gov'tSubject headings: *Carbon Compounds, Inorganic | *Chromium Alloys | *Coronary Stenosis/th [Therapy] | *Coronary Vessels/ra [Radiography] | *Drug-Eluting Stents | *Percutaneous Coronary Intervention/mt [Methods] | *Silicon Compounds | *Sirolimus | Aged | Coronary Angiography | Coronary Restenosis/ep [Epidemiology] | Coronary Stenosis/co [Complications] | Drug-Eluting Stents/ae [Adverse Effects] | Female | Follow-Up Studies | Humans | Hyperplasia/ep [Epidemiology] | Incidence | Male | Middle Aged | Myocardial Infarction/et [Etiology] | Myocardial Infarction/th [Therapy] | Neointima/pa [Pathology] | Percutaneous Coronary Intervention/ae [Adverse Effects] | Percutaneous Coronary Intervention/is [Instrumentation] | Prospective Studies | Treatment OutcomeYear: 2013ISSN:
  • 1774-024X
Name of journal: EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of CardiologyAbstract: 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.All authors: Deleanu D, Dorobantu M, Hamon M, Niculescu R, Waksman R, Weissman NJFiscal year: FY2014Digital Object Identifier: Date added to catalog: 2013-09-17
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Journal Article MedStar Authors Catalog Article 23339805 Available 23339805

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.

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