普通药物洗脱支架与专用冠状动脉分叉BiOSS专家支架对比：多中心开放标签随机对照POLBOS I试验

Regular Drug-Eluting Stent vs Dedicated Coronary Bifurcation BiOSS Expert Stent: Multicenter Open-Label Randomized Controlled POLBOS I Trial.

作者信息

Gil Robert J, Bil Jacek, Džavík Vladimír, Vassilev Dobrin, Kern Adam, Formuszewicz Radoslaw, Zalewska-Adamiec Małgorzata, Dobrzycki Sławomir

机构信息

Department of Invasive Cardiology, Central Clinical Hospital of the Ministry of Interior, Warsaw, Poland; Institute of Experimental and Clinical Medicine, Polish Academy of Science, Warsaw, Poland.

Department of Invasive Cardiology, Central Clinical Hospital of the Ministry of Interior, Warsaw, Poland.

出版信息

Can J Cardiol. 2015 May;31(5):671-8. doi: 10.1016/j.cjca.2014.12.024. Epub 2014 Dec 24.

DOI:10.1016/j.cjca.2014.12.024

PMID:25828372

Abstract

BACKGROUND

Results of regular drug-eluting stents (rDESs) in bifurcation treatment are not optimal. The aim of the Polish Bifurcation Optimal Stenting I (POLBOS I) trial was to compare bifurcation treatment with any rDES vs the dedicated bifurcation paclitaxel-eluting stent BiOSS Expert (Balton, Poland). The second aim was to study the effect of final kissing balloon (FKB) inflation on clinical outcomes.

METHODS

Between October 2010 and January 2013 patients with stable coronary artery disease or non-ST-elevation acute coronary syndrome were assigned 1:1 to 1 of 2 treatment strategies: BiOSS Expert stent or rDES implantation. Coronary angiography was performed at 12 months. The primary end point was a composite of cardiac-related death, myocardial infarction (MI), and target lesion revascularization (TLR) at 12 months.

RESULTS

The BiOSS Expert was implanted in 120 patients (49.4%), and an rDES was implanted in 123 patients. The target vessel was the left anterior descending (LAD) artery (52% vs 70%) followed by the left main stem (LMS) coronary artery (22% vs 15%). In the rDES group, 38.2% received paclitaxel-eluting stents. There were 3 stent implantation failures (2 in the rDES group and 1 in the BiOSS Expert group). Side branch treatment with an rDES was required in 10% of cases in both groups. At 12 months, the incidence of cumulative major adverse cardiovascular events (MACE) was similar in both groups: 13.3% vs 12.2% (P = 0.7). The TLR rate was significantly higher in the BiOSS Expert group compared with the rDES group (11.5% vs 7.3%; P = 0.02). Significantly lower rates of restenosis were observed in FKB subgroups of both the BiOSS Expert (8.1% vs 13.2%; P < 0.05) and rDES groups (4.9% vs 9.5%; P < 0.05).

CONCLUSIONS

MACE rates were comparable between the 2 groups; however, the TLR rate was higher in the BiOSS Expert group. A more aggressive protocol yielded better angiographic and clinical outcomes.

摘要

背景

常规药物洗脱支架（rDES）用于分叉病变治疗的效果并不理想。波兰分叉病变优化支架置入I（POLBOS I）试验的目的是比较使用任何rDES进行分叉病变治疗与使用专用的紫杉醇洗脱分叉支架BiOSS Expert（波兰Balton公司）的效果。第二个目的是研究最终球囊对吻扩张（FKB）对临床结局的影响。

方法

2010年10月至2013年1月期间，将稳定型冠状动脉疾病或非ST段抬高型急性冠状动脉综合征患者按1:1随机分配至以下两种治疗策略之一：植入BiOSS Expert支架或rDES。在12个月时进行冠状动脉造影。主要终点是12个月时心脏相关死亡、心肌梗死（MI）和靶病变血运重建（TLR）的复合终点。

结果

120例患者（49.4%）植入了BiOSS Expert支架，123例患者植入了rDES。靶血管为左前降支（LAD）动脉（分别为52%和70%），其次是左主干（LMS）冠状动脉（分别为22%和15%）。在rDES组中，38.2%的患者植入了紫杉醇洗脱支架。有3例支架植入失败（rDES组2例，BiOSS Expert组1例）。两组均有10%的病例需要使用rDES对分支进行治疗。12个月时，两组累积主要不良心血管事件（MACE）的发生率相似：分别为13.3%和12.2%（P = 0.7）。BiOSS Expert组的TLR率显著高于rDES组（分别为11.5%和7.3%；P = 0.02）。在BiOSS Expert组（分别为8.1%和13.2%；P < 0.05）和rDES组（分别为4.9%和9.5%；P < 0.05）的FKB亚组中，再狭窄率均显著降低。