Intravascular Imaging-Guided Versus Angiography-Guided Complex PCI in Patients With High Bleeding Risk: A Secondary Analysis of the RENOVATE-COMPLEX PCI Trial.

IF 6.1 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
Jinhwan Jo, Sang Yoon Lee, Woochan Kwon, Seung-Jae Lee, Jong-Young Lee, Seung Hun Lee, Doosup Shin, Sang Min Kim, Kyeong Ho Yun, Jae Young Cho, Chan Joon Kim, Hyo-Suk Ahn, Chang-Wook Nam, Hyuck-Jun Yoon, Yong Hwan Park, Wang Soo Lee, Ki Hong Choi, Taek Kyu Park, Jeong Hoon Yang, Seung-Hyuk Choi, Hyeon-Cheol Gwon, Young Bin Song, Joo-Yong Hahn, Sang Yeub Lee, Joo Myung Lee
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引用次数: 0

Abstract

Background: Although patients with high bleeding risk (HBR) often have complex coronary artery lesions, it is not known whether intravascular imaging-guided percutaneous coronary intervention (PCI) improves their prognosis. We sought to investigate the benefit of intravascular imaging-guided PCI for complex coronary artery lesions in patients with HBR.

Methods: This was a secondary analysis of the RENOVATE-COMPLEX-PCI trial (Randomized Controlled Trial of Intravascular Imaging Guidance Versus Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention) in which patients with complex coronary artery lesions undergoing PCI were enrolled at 20 sites in Korea from May 2018 through May 2021. Patients were randomized to receive intravascular imaging-guided PCI or angiography-guided PCI and classified according to the presence of HBR. The primary end point was target vessel failure, which was a composite of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization.

Results: Of 1639 trial population, 478 patients met HBR criteria. There was no significant difference in the risk of the primary end point between HBR and non-HBR patients (11.8% versus 8.2%; adjusted hazard ratio [HR], 1.05 [95% CI, 0.72-1.54]; P=0.790). However, patients with HBR were at higher risk for cardiac death or spontaneous target vessel-related myocardial infarction (adjusted HR, 2.04 [95% CI, 1.09-3.80]; P=0.025), all-cause death (adjusted HR, 3.30 [95% CI, 1.93-5.62]; P<0.001), and cardiac death (adjusted HR, 2.36 [95% CI, 1.10-5.09]; P=0.028). Intravascular imaging-guided PCI showed a lower risk of the primary end point compared with angiography-guided PCI in both HBR patients (9.7% versus 15.8%; adjusted HR, 0.57 [95% CI, 0.31-1.02]; P=0.060) and non-HBR patients (6.9% versus 10.8%; adjusted HR, 0.65 [95% CI, 0.43-0.99]; P=0.045), without significant interaction (P for interaction=0.796).

Conclusions: Patients with HBR were associated with an increased risk of adverse cardiovascular events after complex PCI compared with those without HBR. Intravascular imaging-guided PCI showed a lower risk of the target vessel failure without significant interaction between treatment strategy and the presence of HBR in patients undergoing complex PCI.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03381872.

高出血风险患者血管内成像引导与血管造影引导下的复杂PCI: RENOVATE-COMPLEX PCI试验的二次分析
背景:虽然高出血风险(HBR)患者通常有复杂的冠状动脉病变,但血管内成像引导下的经皮冠状动脉介入治疗(PCI)是否能改善其预后尚不清楚。我们试图研究血管内成像引导下PCI治疗HBR患者复杂冠状动脉病变的益处。方法:这是对RENOVATE-COMPLEX-PCI试验(血管内成像指导与血管造影指导复杂经皮冠状动脉介入治疗后临床结果的随机对照试验)的二次分析,该试验于2018年5月至2021年5月在韩国的20个地点招募了接受PCI治疗的复杂冠状动脉病变患者。患者随机接受血管内成像引导的PCI或血管造影引导的PCI,并根据HBR的存在进行分类。主要终点是靶血管衰竭,这是心源性死亡、靶血管相关性心肌梗死或临床驱动的靶血管重建术的复合。结果:在1639例试验人群中,478例患者符合HBR标准。HBR和非HBR患者的主要终点风险无显著差异(11.8% vs 8.2%;校正风险比[HR], 1.05 [95% CI, 0.72-1.54];P = 0.790)。然而,HBR患者发生心源性死亡或自发性靶血管相关心肌梗死的风险更高(校正后风险比为2.04 [95% CI, 1.09-3.80];P=0.025),全因死亡(校正风险比3.30 [95% CI, 1.93-5.62];页= 0.028)。在两名HBR患者中,血管内成像引导下的PCI与血管造影引导下的PCI相比,主要终点的风险更低(9.7% vs 15.8%;调整后的HR, 0.57 [95% CI, 0.31-1.02];P=0.060)和非hbr患者(6.9% vs 10.8%;调整后的HR, 0.65 [95% CI, 0.43-0.99];P=0.045),无显著交互作用(交互作用P= 0.796)。结论:与没有HBR的患者相比,有HBR的患者在复杂PCI术后发生不良心血管事件的风险增加。血管内成像引导的PCI显示,在接受复杂PCI的患者中,治疗策略和HBR之间没有明显的相互作用,靶血管衰竭的风险较低。注册:网址:https://www.clinicaltrials.gov;唯一标识符:NCT03381872。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Circulation: Cardiovascular Interventions
Circulation: Cardiovascular Interventions CARDIAC & CARDIOVASCULAR SYSTEMS-
CiteScore
10.30
自引率
1.80%
发文量
221
审稿时长
6-12 weeks
期刊介绍: Circulation: Cardiovascular Interventions, an American Heart Association journal, focuses on interventional techniques pertaining to coronary artery disease, structural heart disease, and vascular disease, with priority placed on original research and on randomized trials and large registry studies. In addition, pharmacological, diagnostic, and pathophysiological aspects of interventional cardiology are given special attention in this online-only journal.
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