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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rDES Group | Active Comparator | regular drug-eluting stent implantation in coronary lesion within bifurcation LucChopin Xience Promus Resolute Integrity Biomatrix Prolim |
|
| BiOSS LIM Group | Experimental | BiOSS LIM® stent implantation into coronary lesion within bifurcation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary angioplasty with stent implantation | Procedure |
|
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| cardiac death | 12 months | |
| all-cause death | 12 months | |
| MI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert J Gil, MD, PhD | Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Clinical Hospital of the Ministry of Interior | Warsaw | Masovian Voivodeship | 02-507 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24708143 | Background | Bil J, Gil RJ, Vassilev D, Rzezak J, Kulawik T, Pawlowski T. Dedicated bifurcation paclitaxel-eluting stent BiOSS Expert(R) in the treatment of distal left main stem stenosis. J Interv Cardiol. 2014 Jun;27(3):242-51. doi: 10.1111/joic.12119. Epub 2014 Apr 7. | |
| 24157310 | Background | Vassilev D, Mateev H, Alexandrov A, Stankev M, Rigatelli G, Gil RJ. Stenting below-the-knee bifurcations with dedicated bifurcation stent BiOSS Lim - first in man case report. Cardiovasc Revasc Med. 2014 Apr;15(3):171-7. doi: 10.1016/j.carrev.2013.09.005. Epub 2013 Oct 22. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000800 | Angioplasty, Balloon |
| D015374 | Biosensing Techniques |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D017130 | Angioplasty |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
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| Dual antipletlet therapy (DAPT) | Drug | DAPT given to each patient before stent implantation |
|
|
myocardial infarction
| 12 months |
| TLR | target lesion revascularization | 12 months |
| TVR | target vessel revascularization | 12 months |
| LLL | late lumen loss | 12 months |
| 23868287 | Background | Gil RJ, Bil J, Michalek A, Vassiliev D, Costa RA. Comparative analysis of lumen enlargement mechanisms achieved with the bifurcation dedicated BiOSS) stent versus classical coronary stent implantations by means of provisional side branch stenting strategy: an intravascular ultrasound study. Int J Cardiovasc Imaging. 2013 Dec;29(8):1667-76. doi: 10.1007/s10554-013-0264-0. Epub 2013 Jul 19. |
| 22829507 | Background | Gil RJ, Vassilev D, Michalek A, Kern A, Formuszewicz R, Dobrzycki S, Wojcik J, Lesiak M, Kardaszewicz P, Lekston A. Dedicated paclitaxel-eluting bifurcation stent BiOSS(R) (bifurcation optimisation stent system): 12-month results from a prospective registry of consecutive all-comers population. EuroIntervention. 2012 Jul 20;8(3):316-24. doi: 10.4244/EIJV8I3A50. |
| 21930466 | Background | Vassilev D, Gil R, Milewski K. Bifurcation Optimisation Stent System (BiOSS Lim) with sirolimus elution: results from porcine coronary artery model. EuroIntervention. 2011 Sep;7(5):614-20. doi: 10.4244/EIJV7I5A98. |
| 33782985 | Derived | Gil RJ, Kern A, Formuszewicz R, Inigo Garcia LA, Dobrzycki S, Vassilev D, Bil J. 6-year results of BiOSS stents in coronary bifurcation treatment. Eur J Clin Invest. 2021 Aug;51(8):e13555. doi: 10.1111/eci.13555. Epub 2021 Mar 29. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D014656 |
| Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |
| D015336 | Molecular Probe Techniques |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |