DES Versus BiOSS LIM - POLBOS II Study

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Procedure: Coronary angioplasty with stent implantation; Drug: Dual antipletlet therapy (DAPT)

• Registration Number: NCT02198300
• Lead Sponsor: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland

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.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2014-07-20
• Study First Submitted QC: 2014-07-21
• Study First Posted: 2014-07-23
• Primary Completion: 2014-12
• Study Completion: 2015-03
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-28
• Last Update Posted: 2015-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rDES Group	Coronary angioplasty with stent implantation	regular drug-eluting stent implantation in coronary lesion within bifurcation LucChopin Xience Promus Resolute Integrity Biomatrix Prolim
BiOSS LIM Group	Dual antipletlet therapy (DAPT)	BiOSS LIM® stent implantation into coronary lesion within bifurcation.
BiOSS LIM Group	Coronary angioplasty with stent implantation	BiOSS LIM® stent implantation into coronary lesion within bifurcation.
rDES Group	Dual antipletlet therapy (DAPT)	regular drug-eluting stent implantation in coronary lesion within bifurcation LucChopin Xience Promus Resolute Integrity Biomatrix Prolim

Primary Outcome Measures

Name	Time	Method
MACE	12 months	Cumulative rate of major adverse cardiovascular events (MACE) including cardiac death, myocardial infarction (MI) and repeated revascularization of the target lesion (TLR)

Secondary Outcome Measures

Name	Time	Method
TVR	12 months	target vessel revascularization
all-cause death	12 months
LLL	12 months	late lumen loss
cardiac death	12 months
MI	12 months	myocardial infarction
TLR	12 months	target lesion revascularization

Trial Locations

Locations (1)

Central Clinical Hospital of the Ministry of Interior; 🇵🇱 Warsaw, Mazowieckie, Poland