Jia Haibo, Dai Jiannan, He Luping, Xu Yishuo, Shi Yongfeng, Zhao Lei, Sun Zhiqi, Liu Yin, Weng Ziqian, Feng Xue, Zhang Dirui, Chen Tao, Zhang Xiling, Li Lulu, Xu Yousheng, Wu Yanqing, Yang Yining, Wang Chunmei, Li Lang, Li Jianping, Hou Jingbo, Liu Bin, Mintz Gary S, Yu Bo
Department of Cardiology, The 2nd Affiliated Hospital of Harbin Medical University, Harbin, China; The Key Laboratory of Myocardial Ischemia, Chinese Ministry of Education, Harbin, China.
Department of Cardiology, The Second Hospital of Jilin University, Changchun, China.
JACC Cardiovasc Interv. 2022 Apr 25;15(8):846-856. doi: 10.1016/j.jcin.2022.01.298. Epub 2022 Mar 30.
The aim of this study was to test whether optical coherence tomographic (OCT) guidance would provide additional useful information beyond that obtained by angiography and lead to a shift in reperfusion strategy and improved clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) with early infarct artery patency.
Angiography is limited in assessing the underlying pathophysiological mechanisms of the culprit lesion.
EROSION III (Optical Coherence Tomography-Guided Reperfusion in ST-Segment Elevation Myocardial Infarction With Early Infarct Artery Patency) is an open-label, prospective, multicenter, randomized, controlled study approved by the ethics committees of participating centers. Patients with STEMI who had angiographic diameter stenosis ≤ 70% and TIMI (Thrombolysis In Myocardial Infarction) flow grade 3 at presentation or after antegrade blood flow restoration were recruited and randomized to either OCT guidance or angiographic guidance. The primary efficacy endpoint was the rate of stent implantation.
Among 246 randomized patients, 226 (91.9%) constituted the per protocol set (112 with OCT guidance and 114 with angiographic guidance). The median diameter stenosis was 54.0% (IQR: 48.0%-61.0%) in the OCT guidance group and 53.5% (IQR: 43.8%-64.0%) in the angiographic guidance group (P = 0.57) before randomization. Stent implantation was performed in 49 of 112 patients (43.8%) in the OCT group and 67 of 114 patients (58.8%) in the angiographic group (P = 0.024), demonstrating a 15% reduction in stent implantation with OCT guidance. In patients treated with stent implantation, OCT guidance was associated with a favorable result with lower residual angiographic diameter stenosis (8.7% ± 3.7% vs 11.8% ± 4.6% in the angiographic guidance group; P < 0.001). Two patients (1 cardiac death, 1 stable angina) met the primary safety endpoint in the OCT guidance group, as did 3 patients (3 cardiac deaths) in the angiographic guidance group (1.8% vs 2.6%; P = 0.67). Reinfarction was not observed in either group. At 1 year, the rates of predefined cardiocerebrovascular events were comparable between the groups (11.6% after OCT guidance vs 9.6% after angiographic guidance; P = 0.66).
In patients with STEMI with early infarct artery patency, OCT guidance compared with angiographic guidance of reperfusion was associated with less stent implantation during primary percutaneous coronary intervention. These favorable results indicate the value of OCT imaging in optimizing the reperfusion strategy of patients with STEMI. (EROSION III: OCT- vs Angio-Based Reperfusion Strategy for STEMI; NCT03571269).
本研究旨在测试光学相干断层扫描(OCT)引导是否能提供超出血管造影所获得的其他有用信息,并导致ST段抬高型心肌梗死(STEMI)且梗死相关动脉早期通畅患者的再灌注策略发生转变及改善临床结局。
血管造影在评估罪犯病变的潜在病理生理机制方面存在局限性。
EROSION III(ST段抬高型心肌梗死伴梗死相关动脉早期通畅的光学相干断层扫描引导再灌注)是一项开放标签、前瞻性、多中心、随机、对照研究,已获得参与中心伦理委员会的批准。招募了STEMI患者,这些患者在就诊时或顺行血流恢复后血管造影直径狭窄≤70%且心肌梗死溶栓试验(TIMI)血流分级为3级,并随机分为OCT引导组或血管造影引导组。主要疗效终点是支架植入率。
在246例随机分组的患者中,226例(91.9%)构成符合方案集(112例接受OCT引导,114例接受血管造影引导)。随机分组前,OCT引导组的中位直径狭窄为54.0%(四分位间距:48.0%-61.0%),血管造影引导组为53.5%(四分位间距:43.8%-64.0%)(P = 0.57)。OCT组112例患者中有49例(占43.8%)接受了支架植入,血管造影组114例患者中有67例(占58.8%)接受了支架植入(P = 0.024),表明OCT引导下支架植入减少了15%。在接受支架植入治疗的患者中,OCT引导与更好的结果相关,残余血管造影直径狭窄更低(OCT引导组为(8.7% ± 3.7%),血管造影引导组为(11.8% ± 4.6%);P < 0.001)。OCT引导组有2例患者(1例心源性死亡,1例稳定型心绞痛)达到主要安全终点,血管造影引导组有3例患者(3例心源性死亡)达到主要安全终点(1.8% vs 2.6%;P = 0.67)。两组均未观察到再梗死。1年时,两组间预设的心脑血管事件发生率相当(OCT引导后为11.6%,血管造影引导后为9.6%;P = 0.66)。
在STEMI且梗死相关动脉早期通畅的患者中,与血管造影引导的再灌注相比,OCT引导在直接经皮冠状动脉介入治疗期间与更少的支架植入相关。这些良好结果表明OCT成像在优化STEMI患者再灌注策略方面的价值。(EROSION III:STEMI基于OCT与基于血管造影的再灌注策略;NCT03571269)