Clinical trial NCT02198300: DES Versus BiOSS LIM - POLBOS II Study
Official title: Regular Drug Eluting Stent Versus Dedicated Bifurcation Sirolimus-eluting Stent BiOSS LIM in Coronary Bifurcation Treatment - Randomized POLBOS II Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: dedicated bifurcation stent
sirolimus eluting stent
Lead sponsor: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
Sponsor class: OTHER
First posted: 2014-07-23
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: MACE
timeFrame: 12 months
Secondary outcomes:
measure: cardiac death
timeFrame: 12 months
measure: all-cause death
timeFrame: 12 months
measure: MI
timeFrame: 12 months
measure: TLR
timeFrame: 12 months
measure: TVR
timeFrame: 12 months
measure: LLL
timeFrame: 12 months
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Central Clinical Hospital of the Ministry of Interior
state: Mazowieckie
Study officials:
affiliation: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
name: Robert J Gil, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.