DES Versus BiOSS LIM - POLBOS II Study

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

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease

Treatments: Procedure: Coronary angioplasty with stent implantation; Drug: Dual antipletlet therapy (DAPT)

Study type: Interventional

Funder types: Other

Identifiers

NCT02198300

2.1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 202 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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202 participants in 2 patient groups

rDES Group

Active Comparator group

Description:

regular drug-eluting stent implantation in coronary lesion within bifurcation LucChopin Xience Promus Resolute Integrity Biomatrix Prolim

Treatment:

Drug: Dual antipletlet therapy (DAPT)

Procedure: Coronary angioplasty with stent implantation

BiOSS LIM Group

Experimental group

Description:

BiOSS LIM® stent implantation into coronary lesion within bifurcation.

Treatment:

Drug: Dual antipletlet therapy (DAPT)

Procedure: Coronary angioplasty with stent implantation