Department of Invasive Cardiology, Central Clinical Hospital of the Ministry of Interior, Warsaw, Poland.
EuroIntervention. 2016 Nov 20;12(10):1246-1254. doi: 10.4244/EIJY15M10_05.
The aim of this study was to assess prospectively the effectiveness and safety of a new version of the dedicated bifurcation BiOSS stent, the sirolimus-eluting BiOSS LIM, for the treatment of distal left main (LM) stenosis.
This was a prospective international registry which enrolled patients with NSTE-ACS or stable angina. Provisional T-stenting was the mandated strategy. The primary endpoint was the cumulative rate of cardiac death, myocardial infarction (MI) and target lesion revascularisation (TLR) at 12 months. Twelve-month quantitative coronary angiography endpoints included late lumen loss and percent diameter stenosis. A total of 74 patients with distal LM stenosis were enrolled. Seventy-three of the 74 patients (aged 67±9 years, 23% women, 20.3% NSTE-ACS, SYNTAX score 22.4±4.4) were successfully treated with the BiOSS LIM stent, with additional side branch placement of regular DES in 11 patients (14.9%). Periprocedural MI occurred in one (1.4%) patient. The 12-month MACE rate was 9.5% without cardiac death or definite stent thrombosis. TLR and MI rates were 6.8% (n=5) and 2.7% (n=2), respectively.
The use of the BiOSS LIM dedicated bifurcation stent for the treatment of distal LM stenosis was feasible and safe, with promising long-term clinical effectiveness.
本研究旨在前瞻性评估新型专用分叉 BiOSS 支架——西罗莫司洗脱 BiOSS LIM 在治疗左主干（LM）远端狭窄中的有效性和安全性。
这是一项前瞻性国际注册研究，纳入了 NSTE-ACS 或稳定性心绞痛患者。临时 T 型支架置入是强制性策略。主要终点是 12 个月时心脏死亡、心肌梗死（MI）和靶病变血运重建（TLR）的累积发生率。12 个月时定量冠状动脉造影的终点包括晚期管腔丢失和直径狭窄百分比。共纳入 74 例 LM 远端狭窄患者。74 例患者中的 73 例（年龄 67±9 岁，女性占 23%，20.3%为 NSTE-ACS，SYNTAX 评分 22.4±4.4）成功接受了 BiOSS LIM 支架治疗，11 例（14.9%）患者额外在分支血管中置入了常规 DES。1 例（1.4%）患者发生围手术期 MI。12 个月时 MACE 发生率为 9.5%，无心脏死亡或明确支架血栓形成。TLR 和 MI 发生率分别为 6.8%（n=5）和 2.7%（n=2）。
使用 BiOSS LIM 专用分叉支架治疗 LM 远端狭窄是可行且安全的，具有良好的长期临床疗效。
