药物涂层球囊联合切割球囊治疗真性冠状动脉分叉病变分支的疗效与安全性：一项多中心、前瞻性、随机对照试验的研究方案

Efficacy and safety of drug-coated balloon combined with cutting balloon for side branch of true coronary bifurcation lesions: Study protocol for a multicenter, prospective, randomized controlled trial.

作者信息

Wu Haoyu, Deng Jizhao, Liang Lei, Lei Xinjun, Yao Xiaowei, Han Wenqi, Chen Haichao, Shou Xiling

机构信息

Department of Cardiology, Shaanxi Provincial People's Hospital, Xi'an, China.

Department of Cardiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.

出版信息

Front Cardiovasc Med. 2022 Nov 3;9:1035728. doi: 10.3389/fcvm.2022.1035728. eCollection 2022.

DOI:10.3389/fcvm.2022.1035728

PMID:36407430

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9669449/

Abstract

BACKGROUND

Coronary bifurcation lesions are common of percutaneous coronary intervention (PCI), and the optimal interventional therapy strategy is still a matter of debate and remains a challenge for interventional cardiologists. The provisional stenting technique is still a preferred method for most bifurcation lesions, but restenosis of the side branch (SB) occurs in approximately 17-19% of cases. Therefore, the dilemma of reducing SB restenosis still exists, and further research on strategies to reduce restenosis for SB is necessary. Drug-coated balloon (DCB) can reduce clinical events in small vessel disease and in-stent restenosis. The efficacy and safety of DCB for SB of true coronary bifurcation lesions have not been fully investigated. A randomized comparison of DCB combined with cutting balloon angioplasty vs. cutting balloon angioplasty for SB has never been published.

METHODS AND DESIGN

The purpose of this study is to explore the superiority of DCB combined with cutting balloon vs. cutting balloon angioplasty for SB after main vessel (MV) drug-eluting stent implantation of true coronary bifurcation lesions. This study is a multicenter, prospective, randomized controlled trial including 140 patients with true coronary bifurcation lesions. Patients will be randomized in a 1:1 manner to receive either DCB combined with cutting balloon or cutting balloon angioplasty for SB after MV drug-eluting stent implantation. The primary endpoint is the evaluation of late lumen loss (LLL) of SB at the 9-month follow-up. The secondary endpoints include procedural success during initial hospitalization, LLL of MV at the 9-month follow-up, binary angiographic restenosis in MV and SB at the 9-month follow-up, the proportion of patients with a final post-PCI quantitative flow ratio result ≤ 0.80 for SB at the 9-month follow-up, and major adverse cardiac events during the 24-month follow-up.

CONCLUSIONS

This clinical trial will provide evidence as to whether DCB combined with cutting balloon for SB of true coronary bifurcation lesions is a superior treatment approach.

TRIAL REGISTRATION NUMBER

ChiCTR2000040475.

DISSEMINATION

The results of this clinical trial will be published in a peer-reviewed journal.

摘要

背景

冠状动脉分叉病变是经皮冠状动脉介入治疗（PCI）中常见的病变，最佳的介入治疗策略仍存在争议，对介入心脏病学家来说仍是一项挑战。临时支架置入技术仍是大多数分叉病变的首选方法，但约17%-19%的病例会发生边支（SB）再狭窄。因此，降低SB再狭窄的困境依然存在，有必要进一步研究降低SB再狭窄的策略。药物涂层球囊（DCB）可减少小血管疾病和支架内再狭窄的临床事件。DCB用于真性冠状动脉分叉病变SB的疗效和安全性尚未得到充分研究。DCB联合切割球囊血管成形术与切割球囊血管成形术治疗SB的随机对照研究尚未发表。

方法与设计

本研究旨在探讨真性冠状动脉分叉病变主支（MV）药物洗脱支架植入术后，DCB联合切割球囊与切割球囊血管成形术治疗SB的优越性。本研究是一项多中心、前瞻性、随机对照试验，纳入140例真性冠状动脉分叉病变患者。患者将以1:1的方式随机分组，在MV药物洗脱支架植入术后接受DCB联合切割球囊或切割球囊血管成形术治疗SB。主要终点是9个月随访时SB的晚期管腔丢失（LLL）评估。次要终点包括初次住院期间的手术成功率、9个月随访时MV的LLL、9个月随访时MV和SB的二元血管造影再狭窄、9个月随访时SB最终PCI后定量血流比结果≤0.80的患者比例，以及24个月随访期间的主要不良心脏事件。