Hong David, Ha Junho, Choi Ki Hong, Lee Seung Hun, Shin Doosup, Lee Jong-Young, Lee Seung-Jae, Lee Sang Yeub, Kim Sang Min, Yun Kyeong Ho, Cho Jae Young, Kim Chan Joon, Ahn Hyo-Suk, Nam Chang-Wook, Yoon Hyuck-Jun, Park Yong Hwan, Lee Wang Soo, Yang Jeong Hoon, Choi Seung-Hyuk, Gwon Hyeon-Cheol, Song Young Bin, Hahn Joo-Yong, Park Taek Kyu, Lee Joo Myung
Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Department of Internal Medicine and Cardiovascular Center, Chonnam National University Hospital, Gwangju, Korea.
Rev Esp Cardiol (Engl Ed). 2025 Jun;78(6):542-552. doi: 10.1016/j.rec.2024.11.007. Epub 2024 Dec 4.
Recent randomized controlled trials support the use of intravascular imaging-guided percutaneous coronary intervention (PCI) to improve patient prognosis. However, the subsequent risk of clinical events in patients with coronary artery disease is not determined solely by lesion characteristics or how these lesions are treated. The current study investigated whether the effects of intravascular imaging in complex PCI vary according to atherothrombotic risks.
This study was a post hoc analysis of the RENOVATE-COMPLEX-PCI trial, which compared intravascular imaging-guided PCI with angiography-guided PCI in patients with complex coronary artery lesions. The study population was stratified by atherothrombotic risk, assessed using the Thrombolysis in Myocardial Infarction risk score for secondary prevention (TRS-2P). TRS-2P is calculated based on the presence of the following factors: age ≥ 75 years, diabetes mellitus, hypertension, smoking, peripheral arterial disease, stroke, coronary artery bypass grafting, heart failure, and renal dysfunction. Patients were categorized into low-risk (TRS-2P <3) or high-risk (TRS-2P ≥ 3) groups. The primary endpoint was target vessel failure, a composite of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization.
Among the total study population, 1247 patients were categorized as low-risk, and 392 as high-risk. The risk of target vessel failure was significantly higher in the high-risk group than in the low-risk group (15.5% vs 7.2%; HR, 2.13; 95%CI, 1.51-3.00; P <.001). The benefits of intravascular imaging-guided PCI over angiography-guided PCI did not differ between the low-risk group (5.6% vs 10.4%; HR, 0.56; 95%CI, 0.36-0.86) and the high-risk group (14.1% vs 18.5%; HR, 0.71; 95%CI, 0.41-1.24), with no significant interaction (interaction P=.496).
In this hypothesis-generating post hoc analysis of the RENOVATE-COMPLEX-PCI trial, patients with high atherothrombotic risk had significantly worse clinical outcomes than those with low atherothrombotic risk. Nevertheless, the prognostic impact of intravascular imaging-guided PCI compared with angiography-guided PCI was similarly observed in both low- and high-risk groups. RENOVATE-COMPLEX-PCI clinical trial register number: NCT03381872.
近期的随机对照试验支持使用血管内成像引导的经皮冠状动脉介入治疗（PCI）来改善患者预后。然而，冠心病患者随后发生临床事件的风险并非仅由病变特征或这些病变的治疗方式决定。本研究调查了血管内成像在复杂PCI中的效果是否因动脉粥样硬化血栓形成风险而异。
本研究是对RENOVATE-COMPLEX-PCI试验的事后分析，该试验比较了血管内成像引导的PCI与血管造影引导的PCI在复杂冠状动脉病变患者中的应用。研究人群根据动脉粥样硬化血栓形成风险进行分层，使用心肌梗死溶栓二级预防风险评分（TRS-2P）进行评估。TRS-2P基于以下因素的存在进行计算：年龄≥75岁、糖尿病、高血压、吸烟、外周动脉疾病、中风、冠状动脉旁路移植术、心力衰竭和肾功能不全。患者被分为低风险（TRS-2P<3）或高风险（TRS-2P≥3）组。主要终点是靶血管失败，这是一个包括心源性死亡、靶血管相关心肌梗死或临床驱动的靶血管血运重建的复合终点。
在整个研究人群中，1247例患者被分类为低风险，392例为高风险。高风险组的靶血管失败风险显著高于低风险组（15.5%对7.2%；HR，2.13；95%CI，1.51 - 3.00；P<.001）。血管内成像引导的PCI优于血管造影引导的PCI的益处，在低风险组（5.6%对10.4%；HR，0.56；95%CI，0.36 - 0.86）和高风险组（14.1%对18.5%；HR，0.71；95%CI，0.41 - 1.24）之间没有差异，且无显著交互作用（交互作用P = 0.496）。
在这项对RENOVATE-COMPLEX-PCI试验的产生假设的事后分析中，动脉粥样硬化血栓形成高风险患者的临床结局明显比低风险患者差。然而，在低风险和高风险组中，血管内成像引导的PCI与血管造影引导的PCI相比，对预后的影响相似。RENOVATE-COMPLEX-PCI临床试验注册号：NCT03381872。
