POLish Bifurcation Optimal Stenting Study

Study Overview
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Brief Summary
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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).

Official Title
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Regular DES Versus BiOSS Expert® Stent in Coronary Bifurcation Treatment - Randomized, Multicenter, Open-label, Controlled POLBOS I (POLish Bifurcation Optimal Stenting) Study

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Coronary angioplasty with stent implantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: rDES Group<br>Regular drug-eluting stent implantation, one of the following: Device: LucChopin (Balton, Poland) Device: Prolim (Balton, Poland) Device: Xience Pro (Abott Vascular) Device: Biomatrix (Biosensors) Device: Promus (Boston Scientific) Device: Cypher (Cordis) Device: Taxus (Boston Scientific) Device: Coroflex Please (BBraun) Device: Resolute Integrity (Medtronic) | Procedure: Coronary angioplasty with stent implantation<br>* Coronary angioplasty in bifurcation lesion with drug-eluting stent implantation: BiOSS or regular DES (rDES)<br>* Other names: Device: Resolute Integrity (Medtronic);|
| Experimental: BiOSS Group<br>New dedicated bifurcation stent BiOSS Expert (Balton, Warsaw, Poland) implantation | Procedure: Coronary angioplasty with stent implantation<br>* Coronary angioplasty in bifurcation lesion with drug-eluting stent implantation: BiOSS or regular DES (rDES)<br>* Other names: Device: Resolute Integrity (Medtronic);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE | 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). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac death |  | 12 months | 
| all-cause death |  | 12 months | 
| Target lesion revascularization |  | 12 months | 
| Target vessel revascularization |  | 12 months | 
| myocardial infarction |  | 12 months | 
| late lumen loss |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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provisional T stenting, dedicated bifurcation stent