BACKGROUND Intravascular imaging plays an important part in diagnosis of vascular conditions and providing insight for treatment strategy. Two main imaging modalities are intravascular ultrasound (IVUS) and optical coherence tomography (OCT). The objective of this study was to prove non-inferiority of OCT imaging to IVUS images in matched segments of peripheral vessels in patients with suspected peripheral vascular disease. METHODS The SCAN study was a prospective, non-inferiority clinical study of matched IVUS and OCT images collected along defined segments of peripheral vessels from twelve subjects (mean age 68 ± 10.3 years; 10 men) displaying symptoms of vascular disease. Luminal diameters were measured by both imaging systems at the distal, middle, and proximal points of the defined segments. Three blinded interventional radiologists evaluated the quality of both imaging modalities in identifying layered structures (3-point grading), plaque (5-point grading), calcification (5-point grading), stent structure (3-point grading), and artifacts (3-point grading) from 240 randomly ordered images. Mean grading scores and luminal diameters were calculated and analyzed with Student's t-Test and Mann-Whitney-Wilcoxon testing. Intrareader reproducibility was calculated by intraclass correlation (ICC) analysis. RESULTS The mean scoring of plaque, calcification, and vascular stent struts by the three readers was significant better in terms of image quality for OCT than IVUS (p < 0.001, p = 0.001, p = 0.004, respectively). The mean scores of vessel wall component visibility and artifacts generated by the two imaging systems were not significantly different (p = 0.19, p = 0.07, respectively). Mean vessel luminal diameter and area at three specific locations within the vessels were not significantly different between the two imaging modalities. No patient injury, adverse effect or device malfunction were noted during the study. CONCLUSIONS Imaging by OCT provides the physician with better visualization of some vessel and plaque chacteristics, but both IVUS and OCT imaging are safe and effective methods of examining peripheral vessels in order to perform diagnostic assessment of peripheral vessels and provide information necessary for the treatment strategy of peripheral artery disease. TRIAL REGISTRATION NCT03480685 registered on 29 March 2018.

中文翻译：

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针对诊断目的比较光学相干断层扫描和血管内超声成像（SCAN）的外周血管成像的上市后多血管评估。

背景技术血管内成像在血管状况的诊断和为治疗策略提供见解中起着重要的作用。两种主要的成像方式是血管内超声（IVUS）和光学相干断层扫描（OCT）。这项研究的目的是证明在怀疑有周围血管疾病的患者中，OCT成像相对于IVUS图像在外周血管匹配段中不亚于劣势。方法SCAN研究是一项前瞻性，非劣质性临床研究，它是从12名受试者（平均年龄68±10.3岁； 10名男性）的周围血管定义段采集的匹配IVUS和OCT图像，显示血管疾病的症状。通过两个成像系统在定义的节段的远端，中间和近端点测量光通量直径。三位不知情的介入放射科医生评估了两种成像方式在识别分层结构（3点分级），牙斑（5点分级），钙化（5点分级），支架结构（3点分级）和伪影（ 3点分级）来自240个随机排序的图像。计算平均分级分数和管腔直径，并通过Student's t检验和Mann-Whitney-Wilcoxon检验进行分析。阅读器内可重复性是通过类内相关性（ICC）分析来计算的。结果在OCT的图像质量方面，三位读者的平均斑块，钙化和血管支架撑杆得分均明显高于IVUS（分别为p <0.001，p = 0.001，p = 0.004）。由两个成像系统生成的血管壁成分可见性和伪影的平均得分没有显着差异（分别为p = 0.19，p = 0.07）。两种成像方式之间，在三个特定位置的平均血管腔直径和面积没有显着差异。研究期间未发现患者受伤，不良反应或设备故障。结论OCT成像可为医生更好地可视化某些血管和斑块特征，但IVUS和OCT成像均是检查外周血管的安全有效方法，以便对外周血管进行诊断评估并提供治疗策略所需的信息。外周动脉疾病。试用注册NCT03480685已于2018年3月29日注册。