糖尿病患者血管内成像引导与血管造影引导下经皮冠状动脉介入治疗：一项国际、多中心、随机ii型糖尿病试验的理论基础和设计

IF 3.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal Pub Date : 2025-02-04 DOI:10.1016/j.ahj.2025.01.017

Xiao-Fei Gao , Jing Kan , Hao-Yu Wu , Jing Chen , Xiang Chen , Shang-Yu Wen , Yong-Tai Gong , Qian Tong , Jun Luo , Yi-Bing Shao , Badar Ul Ahad Gill , Fazila Tun Nesa Malik , Teguh Santoso , Ramesh Daggubati , Alfredo E. Rodriguez , Lavarra Francesco , Afzalur Rahman , Imad Sheiban , Sasko Kedev , Muhammad Munawar , Shao-Liang Chen

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引用次数: 0

摘要

背景：与血管造影指导相比，血管内成像（IVI）引导下的经皮冠状动脉介入治疗（PCI）可以改善复杂病变或急性冠状动脉综合征患者的临床预后。然而，这种方法对糖尿病患者的影响尚不清楚。试验设计：iv - diabetes试验是一项研究者发起的、前瞻性的、国际的、多中心的随机试验，涉及至少30个站点，旨在招募1332例接受PCI治疗的糖尿病合并阻塞性冠状动脉疾病患者。所有入组患者以1:1的比例随机分配，接受IVI引导的PCI或血管造影引导的PCI。在血管内超声或光学相干断层扫描之间的选择是由操作者自行决定的。主要终点是12个月时靶血管衰竭（TVF），由心源性死亡、靶血管心肌梗死（MI）或临床驱动的靶血管重建术的组合来定义。主要次要终点为无手术相关心肌梗死的TVF。出院后，通过1、6和12个月的临床随访或电话联系进行随访。随访将每年持续至指数程序后5年，以评估长期结果。结论：IVI-DIABETES试验是首个旨在探讨ivi引导下的PCI与血管造影引导下的PCI在糖尿病患者中的临床疗效和安全性的研究。试验注册：clinicaltrials.gov, NCT06380868。

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Intravascular imaging-guided versus angiography-guided percutaneous coronary intervention in patients with diabetes mellitus: Rationale and design of an international, multicenter, randomized IVI-DIABETES trial

Background

Intravascular imaging (IVI)- guided percutaneous coronary intervention (PCI) can improve clinical outcomes compared with angiography guidance in patients with complex lesions or acute coronary syndrome. However, the impact of this approach among diabetic patients remains unknown.

Trial design

IVI-DIABETES trial is an investigator-initiated, prospective, international, multicenter, randomized trial, involving at least 30 sites, aiming to enroll 1,332 diabetic patients with obstructive coronary artery disease undergoing PCI. All enrolled patients are randomly assigned in a 1:1 fashion to undergo IVI- guided PCI or angiography- guided PCI. The choice between intravascular ultrasound or optical coherence tomography is at the discretion of the operator. The primary endpoint is target vessel failure (TVF) at 12 months, defined by the composite of cardiac death, target vessel myocardial infarction (MI), or clinically-driven target vessel revascularization. The major secondary endpoint is TVF without procedure-related MI. After hospital discharge, follow-up is conducted through clinical visits or telephone contact at 1, 6, and 12 months. The follow-up will continue annually until 5 years after the index procedure to assess the long-term outcomes.

Conclusion

IVI-DIABETES trial is the first study designed to investigate the clinical efficacy and safety of IVI-guided PCI in diabetic patients compared to angiography-guided PCI.

Trial registration

clinicaltrials.gov, NCT06380868.

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来源期刊

American heart journal 医学-心血管系统

CiteScore

8.20

自引率

2.10%

发文量

214

审稿时长

38 days

期刊介绍： The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.