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冠状动脉分叉病变中近端优化技术与最终球囊对吻扩张的比较:随机、多中心 PROPOT 试验。

Proximal optimisation technique versus final kissing balloon inflation in coronary bifurcation lesions: the randomised, multicentre PROPOT trial.

机构信息

Department of Medicine, Division of Cardiology, Teikyo University School of Medicine, Tokyo, Japan.

出版信息

EuroIntervention. 2021 Oct 20;17(9):747-756. doi: 10.4244/EIJ-D-20-01386.

Abstract

BACKGROUND

Clinical implications of the proximal optimisation technique (POT) for bifurcation lesions have not been investigated in a randomised controlled trial.

AIMS

This study aimed to investigate whether POT is superior in terms of stent apposition compared with the conventional kissing balloon technique (KBT) in real-life bifurcation lesions using optical coherence tomography (OCT).

METHODS

A total of 120 patients from 15 centres were randomised into two groups - POT followed by side branch dilation or KBT. Finally, 57 and 58 patients in the POT and KBT groups, respectively, were analysed. OCT was performed at baseline, immediately after wire recrossing to the side branch, and at the final procedure.

RESULTS

The primary endpoint was the rate of malapposed struts assessed by the final OCT. The rate of malapposed struts did not differ between the POT and KBT groups (in-stent proximal site: 10.4% vs 7.7%, p=0.33; bifurcation core: 1.4% vs 1.1%, p=0.67; core's distal edge: 6.2% vs 5.3%, p=0.59). More additional treatments were required among the POT group (40.4% vs 6.9%, p<0.01). At one-year follow-up, only one patient in each group underwent target lesion revascularisation (2.0% vs 1.9%).

CONCLUSIONS

POT followed by side branch dilation did not show any advantages over conventional KBT in terms of stent apposition; however, excellent midterm clinical outcomes were observed in both strategies.

摘要

背景

在随机对照试验中,尚未研究分叉病变近端优化技术(POT)的临床意义。

目的

本研究旨在使用光学相干断层扫描(OCT)研究在真实分叉病变中,与传统的对吻球囊技术(KBT)相比,POT 在支架贴壁方面是否更具优势。

方法

共 15 个中心的 120 名患者被随机分为两组 - POT 后行分支扩张或 KBT。最终,POT 和 KBT 组分别有 57 名和 58 名患者进行了分析。OCT 在基线、导丝重新进入分支后即刻以及最终程序时进行。

结果

主要终点是通过最终 OCT 评估的贴壁不良支架的比例。POT 和 KBT 组之间贴壁不良支架的比例没有差异(支架内近端部位:10.4% vs 7.7%,p=0.33;分叉核心:1.4% vs 1.1%,p=0.67;核心的远端边缘:6.2% vs 5.3%,p=0.59)。POT 组需要更多的附加治疗(40.4% vs 6.9%,p<0.01)。在一年的随访中,每组只有一名患者接受了靶病变血运重建(2.0% vs 1.9%)。

结论

在支架贴壁方面,POT 后行分支扩张与传统的 KBT 相比没有任何优势;然而,两种策略均观察到了优异的中期临床结果。

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