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糖尿病合并急性冠状动脉综合征患者中血管内超声引导与血管造影引导下的经皮冠状动脉介入治疗:血管内超声-急性冠状动脉综合征试验

IVUS-Guided vs Angiography-Guided PCI in Patients With Diabetes With Acute Coronary Syndromes: The IVUS-ACS Trial.

作者信息

Gao Xiaofei, Kan Jing, Wu Zhiming, Anjun Mohammad, Chen Xiang, Chen Jing, Sheiban Imad, Mintz Gary S, Zhang Jun-Jie, Stone Gregg W, Chen Shao-Liang

机构信息

Nanjing First Hospital, Nanjing Medical University, Nanjing, China.

Punjab Institute of Cardiology, Lahore, Pakistan.

出版信息

JACC Cardiovasc Interv. 2025 Feb 10;18(3):283-293. doi: 10.1016/j.jcin.2024.09.061. Epub 2024 Oct 28.

Abstract

BACKGROUND

Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) reduces the risk for clinical events in patients with acute coronary syndromes (ACS), compared with angiographic guidance. However, the benefits of IVUS guidance in high-risk patients with diabetes with ACS is uncertain.

OBJECTIVES

The aim of this prespecified stratified subgroup analysis from the IVUS-ACS randomized trial was to determine the effectiveness of IVUS-guided PCI vs angiography-guided PCI in patients with diabetes with ACS.

METHODS

From August 20, 2019, to October 27, 2022, 1,105 patients with diabetes with ACS were randomized, including 554 patients in the IVUS-guided group and 551 in the angiography-guided group. The primary endpoint was the rate of target vessel failure (TVF) at 1 year, defined as the composite of cardiac death, target vessel myocardial infarction, or clinically driven target vessel revascularization.

RESULTS

At 1-year follow-up, TVF occurred in 20 patients in the IVUS guidance group and in 46 patients in the angiographic guidance group (Kaplan-Meier rates 3.6% vs 8.3%; HR: 0.46; 95% CI: 0.27-0.81; P = 0.007), driven by a reduction in clinically driven target vessel revascularization (0.9% vs 3.8%; P = 0.003). IVUS-guided PCI also reduced the risk for TVF without procedural myocardial infarction (2.0% vs 6.7%; HR: 0.29; 95% CI: 0.15-0.57; P < 0.001) and all-cause mortality (HR: 0.30; 95% CI: 0.10-0.93; P = 0.037). There were no significant differences in the rates of stent thrombosis or major bleeding between the groups.

CONCLUSIONS

In the large-scale IVUS-ACS trial, IVUS-guided PCI improved 1-year clinical outcomes in high-risk patients with diabetes with ACS. (1-Month vs 12-Month DAPT for ACS Patients Who Underwent PCI Stratified by IVUS: IVUS-ACS and ULTIMATE-DAPT Trials; NCT03971500).

摘要

背景

与血管造影引导相比,血管内超声(IVUS)引导的经皮冠状动脉介入治疗(PCI)可降低急性冠状动脉综合征(ACS)患者发生临床事件的风险。然而,IVUS引导对高危糖尿病合并ACS患者的益处尚不确定。

目的

这项来自IVUS-ACS随机试验的预先指定分层亚组分析的目的是确定IVUS引导的PCI与血管造影引导的PCI在糖尿病合并ACS患者中的有效性。

方法

从2019年8月20日至2022年10月27日,对1105例糖尿病合并ACS患者进行随机分组,其中IVUS引导组554例,血管造影引导组551例。主要终点是1年时的靶血管失败(TVF)率定义为心源性死亡、靶血管心肌梗死或临床驱动的靶血管血运重建的复合事件。

结果

在1年随访时,IVUS引导组有20例患者发生TVF,血管造影引导组有46例患者发生TVF(Kaplan-Meier率分别为3.6%和8.3%;HR:0.46;95%CI:0.27-0.81;P=0.007),这是由于临床驱动的靶血管血运重建减少所致(0.9%对3.8%;P=0.003)。IVUS引导的PCI还降低了无程序性心肌梗死的TVF风险(2.0%对6.7%;HR:0.29;95%CI:0.15-0.57;P<0.001)和全因死亡率(HR:0.30;95%CI:0.10-0.93;P=0.037)。两组之间的支架血栓形成率或大出血率无显著差异。

结论

在大规模的IVUS-ACS试验中,IVUS引导的PCI改善了高危糖尿病合并ACS患者的1年临床结局。(根据IVUS分层的接受PCI的ACS患者的1个月与12个月双联抗血小板治疗:IVUS-ACS和ULTIMATE-DAPT试验;NCT03971500)。

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