DES Versus BiOSS LIM - POLBOS II Study

Coronary Artery Disease Clinical Trial

— POLBOS II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02198300
• Other study ID #: 2.1
• Status: Completed
• Phase: Phase 4
• First received: July 20, 2014
• Last updated: July 28, 2015
• Start date: November 2012
• Est. completion date: March 2015

Study information

• Verified date: July 2015
• Source: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Coronary angioplasty with stent implantation

Drug:
• Dual antipletlet therapy (DAPT)
DAPT given to each patient before stent implantation

Locations

Country	Name	City	State
Poland	Central Clinical Hospital of the Ministry of Interior	Warsaw	Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland

Country where clinical trial is conducted

Poland, 

References & Publications (5)

Bil J, Gil RJ, Vassilev D, Rzezak J, Kulawik T, Pawlowski T. Dedicated bifurcation paclitaxel-eluting stent BiOSS Expert® 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. — View 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. — View Citation

Gil RJ, Vassilev D, Michalek A, Kern A, Formuszewicz R, Dobrzycki S, Wójcik J, Lesiak M, Kardaszewicz P, Lekston A. Dedicated paclitaxel-eluting bifurcation stent BiOSS® (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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	cardiac death		12 months	Yes
Secondary	all-cause death		12 months	Yes
Secondary	MI	myocardial infarction	12 months	Yes
Secondary	TLR	target lesion revascularization	12 months	No
Secondary	TVR	target vessel revascularization	12 months	No
Secondary	LLL	late lumen loss	12 months	No