Department of Cardiology, Institut Mutualiste Montsouris, Paris, France.
EuroIntervention. 2021 Jun 11;17(2):e124-e131. doi: 10.4244/EIJ-D-20-01121.
Intravascular ultrasound (IVUS)-guided PCI improves the prognosis of left main stem (LMS) PCI and is currently recommended by international guidelines. Although OCT resolution is greater than that of IVUS, this tool is not yet recommended in LMS angioplasty due to the absence of data.
This pilot study aimed to analyse the feasibility, safety and impact of OCT-guided LMS PCI.
This prospective, multicentre trial investigated whether patients might benefit from OCT-guided PCI for mid/distal LMS according to a pre-specified protocol. The primary endpoint was procedural success defined as follows: residual angiographic stenosis <50% + TIMI 3 flow in all branches + adequate OCT stent expansion (LEMON criteria).
Seventy patients were included in the final analysis (median age: 72 [64-81] years, 73% male). The OCT pre-specified protocol was applied in all patients. The primary endpoint was achieved in 86% of subjects. Adequate stent expansion was observed in 86%, significant edge dissection in 30% and residual significant strut malapposition in 24% of the cases. OCT guidance modified the operators' strategy in 26% of the patients. The rate of one-year survival free from major adverse clinical events was 98.6% (97.2-100).
This pilot study is the first to report the feasibility and performance of OCT-guided LMS PCI according to a pre-specified protocol.
血管内超声(IVUS)指导下的 PCI 可改善左主干(LMS)PCI 的预后,目前被国际指南推荐。尽管 OCT 的分辨率大于 IVUS,但由于缺乏数据,该工具在 LMS 血管成形术中尚未被推荐。
本研究旨在分析 OCT 指导的 LMS PCI 的可行性、安全性和影响。
这是一项前瞻性、多中心试验,根据预先设定的方案,研究了患者是否可能受益于 OCT 指导的 LMS 近段/中段 PCI。主要终点定义为:残余血管造影狭窄<50%+所有分支 TIMI 3 血流+OCT 支架充分扩张(LEMON 标准)。
70 例患者最终纳入分析(中位年龄:72[64-81]岁,73%为男性)。所有患者均应用 OCT 预设方案。主要终点在 86%的患者中达到。86%的患者支架充分扩张,30%的患者出现明显边缘夹层,24%的患者出现残余明显支架贴壁不良。OCT 指导改变了 26%患者的操作策略。一年无重大不良临床事件的生存率为 98.6%(97.2-100)。
这是第一项根据预设方案报告 OCT 指导的 LMS PCI 的可行性和性能的研究。