DES Versus BiOSS LIM - POLBOS II 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. Provisional T-stenting (PTS) is the best treatment strategy at the moment. However, 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. POLBOS II study is continuation of POLBOS I (POLish Bifurcation Optimal Stenting) study, in which paclitaxel-eluting stent BiOSS Expert® (Balton, Poland) was assessed. Now performance of sirolimus-eluting stent BiOSS LIM® (Balton, Poland) is verified.

Detailed Description
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After signing the informed consent patients were randomly assigned to one of two treatment strategies: BiOSS LIM® stent implantation or rDES implantation (envelope randomization, 1:1). If the patient was enrolled to rDES Group there was a second randomization: with or without final kissing ballooning (FKB). Clinical follow-up was performed with office visits or telephone contacts at 1 and 12 months after intervention. Adverse events were monitored throughout the study period. Follow-up coronary angiography was performed at 12 months unless clinically indicated earlier.

Official Title
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Regular Drug Eluting Stent Versus Dedicated Bifurcation Sirolimus-eluting Stent BiOSS LIM in Coronary Bifurcation Treatment - Randomized POLBOS II Study.

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Coronary angioplasty with stent implantation
* Drug: Dual antipletlet therapy (DAPT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: stable coronary artery disease (CAD) or non-ST-segment elevation acute coronary syndrome (NSTE-ACS) age ≥ 18 years old, de novo coronary bifurcation lesion (including unprotected LMS), MV diameter ≥ 2.5 mm and SB diameter ≥ 2.0 mm assessed by visual estimation. Exclusion Criteria: ST-elevation myocardial infarction (STEMI), bifurcations with Medina type 0,0,1, serum creatinine level ≥ 2.0 mg/dl, inability to take dual antiplatelet therapy for 12 months, left ejection fraction ≤ 30% lack of an informed consent

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 in coronary lesion within bifurcation LucChopin Xience Promus Resolute Integrity Biomatrix Prolim | Procedure: Coronary angioplasty with stent implantation<br> <br> * Other names: device: Prolim (Balton, Poland);Drug: Dual antipletlet therapy (DAPT)<br>* DAPT given to each patient before stent implantation<br>* Other names: clopidogrel;|
| Experimental: BiOSS LIM Group<br>BiOSS LIM® stent implantation into coronary lesion within bifurcation. | Procedure: Coronary angioplasty with stent implantation<br> <br> * Other names: device: Prolim (Balton, Poland);Drug: Dual antipletlet therapy (DAPT)<br>* DAPT given to each patient before stent implantation<br>* Other names: clopidogrel;|

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) and 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 | 
| MI | myocardial infarction | 12 months | 
| TLR | target lesion revascularization | 12 months | 
| TVR | target vessel revascularization | 12 months | 
| LLL | late lumen loss | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dedicated bifurcation stent, sirolimus eluting stent