Coronary Artery Disease
Conditions
Keywords
provisional T stenting, dedicated bifurcation stent
Brief summary
Coronary bifurcation lesions pose therapeutic problems during percutaneous coronary interventions (PCI) and are associated with higher rates of periprocedural complications as well as higher rates of in-stent restenosis and stent thrombosis. Therefore the optimal approach to coronary bifurcations treatment is still a subject of debate, especially when the side branch is large, not easily accessible and narrowed by a long lesion. One of the proposed alternatives are dedicated bifurcation stents (DBS). However, there is large scarcity of randomized trials with DBS. The aim of POLBOS I (POLish Bifurcation Optimal Stenting) study was to compare two intervention strategies for bifurcation treatment: provisional T-stenting (PTS) with any regular drug-eluting stent (rDES), the best treatment strategy at the moment, with stenting of bifurcation lesions with dedicated bifurcation paclitaxel-eluting stent BiOSS Expert® (Balton, PL).
Interventions
Coronary angioplasty in bifurcation lesion with drug-eluting stent implantation: BiOSS or regular DES (rDES)
Sponsors
University National Heart Hospital
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Subject able to verbally confirm understandings of risks, benefits of receiving PCI for true bifurcation lesions, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure. * Target main branch lesion(s) located in a native coronary artery with diameter of ≥ 2.5 mm and ≤ 4.5 mm. Target side branch lesion(s) located in a native coronary artery with diameter of ≥ 2.0 mm. * Target lesion(s) amenable for PCI with balloon angioplasty of the side branch.
Exclusion criteria
* STEMI * Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment). * Subjects who refuse to give informed consent. * Subjects with LVEF\<30% * Subjects with moderate or severe degree valvular heart disease or primary cardiomyopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACE | 12 months | Cumulative rate of major adverse cardiovascular events (MACE) including cardiac death, myocardial infarction (MI) with or without ST-segment elevation and need for repeated revascularization of the target lesion (TLR). |
Secondary
| Measure | Time frame |
|---|---|
| all-cause death | 12 months |
| Target lesion revascularization | 12 months |
| cardiac death | 12 months |
| myocardial infarction | 12 months |
| late lumen loss | 12 months |
| Target vessel revascularization | 12 months |
Countries
Poland
Outcome results
None listed