DES Versus BiOSS LIM - POLBOS II Study

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02198300

Acronym

POLBOS II

Enrollment

202

Registered

2014-07-23

Start date

2012-11-30

Completion date

2015-03-31

Last updated

2015-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

dedicated bifurcation stent, sirolimus eluting stent

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.

Interventions

PROCEDURECoronary angioplasty with stent implantation

DRUGDual antipletlet therapy (DAPT)

DAPT given to each patient before stent implantation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
all-cause death	12 months	—
MI	12 months	myocardial infarction
cardiac death	12 months	—
TVR	12 months	target vessel revascularization
LLL	12 months	late lumen loss
TLR	12 months	target lesion revascularization

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026