الفهرس 
Introduction and aim of the workOnly 14 pages are availabe for public view
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Abstract
The BiOSS Expert is a dedicated coronary bifurcation balloon expandable stent made of 316L stainless steel with a strut thickness of 120 μm and covered with a mixture of biodegradable polymer and an anti-proliferative substance — paclitaxel. The BiOSS Expert has a unique delivery system, which assures exact stent placement at the point of the bifurcation.
Aim of the work:
To evaluate the acute success, the in hospital outcome and intermediate term outcome of a new stent dedicated for coronary bifurcation stenosis (BiOSS)
Methods:
This study was conducted on 40 patients with coronary bifurcation lesions amenable to percutaneous stenting. Patients divided non randomly into two groups, each group included 20 patients. (BiOSS DES were used in group I while traditional DES were used in group II)
The Inclusion criteria were: Patients with symptomatic ischemic heart disease with any type of coronary bifurcation lesions (except medina 001) with side branch 2.0 mm or more.
The Exclusion criteria were: Contraindications for cardiac catheterization, patient with life expectancy less than the follow up period (6 months)
Every patient was subjected to:
1) Thorough history taking, 12-lead ECG and echocardiography.
2) Coronary angiography:
a- Preprocedural; followed by lesion evaluation and PCI. BiOSS DES stents used in group I and traditional DES in group II.
b- Follow up coronary angiography after 6 months to assess the stent or earlier if there is ischemic chest pain.
The primary endpoint was the incidence of major adverse cardiac events (cardiac death, myocardial infarction with or without ST- segment elevation & clinically driven TVR) 180 days after enrollment.
The secondary endpoint was the device performance and peri-procedural safety.
Results:
No statistically significance differences between both groups as regard variables of baseline demographic and clinical characteristics of patients including (age, sex, risk factors, history of CAD, clinical examination and echocardiography) as well as baseline lesion and procedural characteristics.
There was no statistically significant difference between the two groups as regard the primary End Point and the secondary End Point.
The initial success including (device, lesion and procedure success) was 100% in both groups, No statistically significant difference between the two groups as regards in-hospital complications.
There was no death or myocardial infarction during the index hospitalization, at 30 days and 6 months of follow up for any patients in both groups during the study.
Follow up coronary angiography were done for 15 patients (75%) in group I and 16 patients (80%) in group II (P=0.705), only one patient (6.7%) showed instent restenosis in group I (BiOSS group) and 2 patients (12.5%) in group II (P=0.583).
Clinically and angiographically driven target vessel revascularization (TVR) were done for only one patient (5%) in group I and 2 patients (10%) in group II (P=0.548).
There was statistically significant less frequent SB compromise, a trend towards less worsening of initial SB stenosis with BiOSS stent as side branch post-dilatation were done for 4 patients (20%) in BiOSS group and for 8 patients (40%) in traditional DES group due to side branch osteal affection after stenting of the main vessel.
Conclusion
Comparing BiOSS stent versus traditional drug eluting stent, the initial procedural success, in-hospital complications, and event-free survival at follow up are the same.
Simple and fast bifurcation treatment with a single dedicated bifurcation stent (BiOSS) is feasible and highly successful (100% implantation rate). The BiOSS stent reduces SB compromise in comparison with traditional drug eluting stent.
Recommendations
Our study showed that BiOSS stent reduces SB compromise in comparison with traditional drug eluting stent, with no significant difference in MACE (1ry end point).
Further randomized multicenter studies with greater number of patients and good follow up are recommended.