Regular Drug Eluting Stent Versus Dedicated Bifurcation Sirolimus-eluting Stent BiOSS LIM in Coronary Bifurcation Treatment - Randomized POLBOS II Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- MACE
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
BiOSS LIM Group
BiOSS LIM® stent implantation into coronary lesion within bifurcation.
干预措施: Dual antipletlet therapy (DAPT) (Drug)
rDES Group
regular drug-eluting stent implantation in coronary lesion within bifurcation LucChopin Xience Promus Resolute Integrity Biomatrix Prolim
干预措施: Coronary angioplasty with stent implantation (Procedure)
rDES Group
regular drug-eluting stent implantation in coronary lesion within bifurcation LucChopin Xience Promus Resolute Integrity Biomatrix Prolim
干预措施: Dual antipletlet therapy (DAPT) (Drug)
BiOSS LIM Group
BiOSS LIM® stent implantation into coronary lesion within bifurcation.
干预措施: Coronary angioplasty with stent implantation (Procedure)
结局指标
主要结局
MACE
时间窗: 12 months
Cumulative rate of major adverse cardiovascular events (MACE) including cardiac death, myocardial infarction (MI) and repeated revascularization of the target lesion (TLR)
次要结局
- all-cause death(12 months)
- LLL(12 months)
- cardiac death(12 months)
- MI(12 months)
- TLR(12 months)
- TVR(12 months)
研究者
Jacek Bil
MD, PhD
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland