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.
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.
- 2013
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.
English
1774-024X
*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 Outcome
MedStar Heart & Vascular Institute
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
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.
English
1774-024X
*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 Outcome
MedStar Heart & Vascular Institute
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't