Pennsylvania Vascular Institute, 420 W. Linfield-Trappe Road Suite 3200, Limerick, PA, 19468, USA.
AMITA Health, 911 N. Elm Street Suite 128, Hinsdale, IL, 60521, USA.
BMC Med Imaging. 2020 Feb 14;20(1):18. doi: 10.1186/s12880-020-0420-7.
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.
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.
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.
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.
NCT03480685 registered on 29 March 2018.
血管内成像在诊断血管疾病和提供治疗策略方面发挥着重要作用。两种主要的成像方式是血管内超声（IVUS）和光相干断层扫描（OCT）。本研究的目的是证明 OCT 成像在疑似外周血管疾病患者的外周血管匹配段与 IVUS 图像相比具有非劣效性。
SCAN 研究是一项前瞻性、非劣效性临床研究，比较了 12 名（平均年龄 68±10.3 岁；男性 10 名）有血管疾病症状患者的外周血管特定段的 IVUS 和 OCT 图像。通过两种成像系统在定义段的远端、中段和近端测量管腔直径。三名盲法介入放射科医生对两种成像方式在识别分层结构（3 分评分）、斑块（5 分评分）、钙化（5 分评分）、支架结构（3 分评分）和伪影（3 分评分）方面的质量进行评估，评分来自 240 张随机排序的图像。计算并分析平均评分和管腔直径，采用学生 t 检验和曼-惠特尼-威尔科克森检验。通过组内相关系数（ICC）分析评估内读者可重复性。
三名读者对 OCT 图像质量的斑块、钙化和血管支架结构评分明显高于 IVUS（p<0.001，p=0.001，p=0.004）。两种成像系统产生的血管壁成分可见度和伪影的平均评分无显著差异（p=0.19，p=0.07）。在血管内三个特定位置的平均血管腔直径和面积在两种成像方式之间无显著差异。在研究过程中，没有发现患者损伤、不良事件或设备故障。
OCT 成像为医生提供了更好的血管和斑块特征可视化，但 IVUS 和 OCT 成像都是安全有效的外周血管检查方法，可用于外周血管的诊断评估，并为外周动脉疾病的治疗策略提供必要信息。
NCT03480685 于 2018 年 3 月 29 日注册。
