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
Nanjing First Hospital, Nanjing Medical University, Nanjing, China.
Punjab Institute of Cardiology, Lahore, Pakistan.
JACC Cardiovasc Interv. 2025 Feb 10;18(3):283-293. doi: 10.1016/j.jcin.2024.09.061. Epub 2024 Oct 28.
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.
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.
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.
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.
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).
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。
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。
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。
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。
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)。