评价国产光学相干断层成像系统临床应用的安全性和准确性

目的评价国产光学相干断层成像(OCT)系统临床应用的安全性和准确性。方法本研究是多中心、前瞻性、自身对照的研究设计。在4家医院入选98例冠心病患者行冠状动脉内OCT检查。使用了两种OCT系统,一种是目前临床应用的Light lab C7 OCT系统(美国,雅培公司),另一种为国产OCT系统(中国,南京沃福曼医疗科技有限公司)。每例患者的靶血管需接受两种OCT检查,使用的先后顺序依据研究随机号码决定。主要研究终点为清晰成像长度(CIL)>24 mm的比例,次要研究终点包括支架内最小管腔直径(MLD)、支架内最小管腔面积(MLA)、冠状动脉内边缘夹层、组织脱垂和贴壁不良等,安全性终点包括器械成功率及术中并发症发生率。结果98例患者中50例患者首先进行国产OCT系统检查,48例患者首先进行Light lab C7 OCT系统检查,随机均衡分配。国产OCT系统与Light lab C7 OCT系统首先检查患者比例50(51.0%)比48(49.0%)],器械成功率98(100.0%)比98(100.0%)]比较,差异均无统计学意义(P>0.999)。两种OCT系统检查的时间间隔为(5.0±0.5)min,两种OCT系统的成像导管送入和退出靶血管过程顺利,无操作故障,检查过程中均无心绞痛、心律失常、夹层及血栓等并发症发生。同一靶血管先后应用国产OCT系统和Light lab C7 OCT系统检查,均获得了清晰的血管影像。国产OCT系统与Light lab C7 OCT系统检查患者CIL>24 mm比例96(98.0%)比96(98.0%),P>0.999]、CIL(41.6±8.8)mm比(40.8±9.3)mm,P=0.691]、清晰支架长度(20.3±3.8)mm比(20.8±3.6)mm,P=0.477]、MLD(2.5±0.4)mm比(2.6±0.5)mm,P=0.341]、MLA(5.8±2.1)mm^2比(5.9±1.9)mm^2,P=0.859]比较,差异均无统计学意义。国产OCT系统与Light lab C7 OCT系统检查冠状动脉内微结构的变化,支架边缘夹层1(1.0%)比1(1.0%)]、组织脱垂42(42.9%)比42(42.9%)]和贴壁不良44(44.9%)比44(44.9%)]比较,差异均无统计学意义(P>0.999)。结论国产OCT系统安全性和有效性与Light lab C7 OCT系统相当。

Evaluation on the safety and accuracy of domestic optical coherence tomography system in clinical application

Objective To evaluate the safety and accuracy of domestic optical coherence tomography system in clinical application.Methods This is a multi-center,randomized controlled study design.OCT examination was performed in patients with coronary heart disease.The patients were performed examination by two types OCT systems in turn:C7(Light lab C7,USA,n=98)and domestic OCT(Nanjing,China,n=98).The primary endpoint was the ratio of clear image length(CIL)>24 mm.The secondary endpoints included the minimum intrastent lumen diameter(MLD),the minimum intrastent lumen area(MLA),intracoronary marginal dissection,tissue prolapse and poor adherence.The safety endpoints included the success rate of instruments and the incidence of intraoperative complications.Results All patients were performed two examinations of domestic OCT system and Light lab C7 OCT system successively,among whom,50 were fi rst with domestic OCT and 48 were fi rst with Light lab C7 system randomly.The proportion of patients in the domestic OCT group and the C7 group who were first examined50(51.0%)vs.48(49.0%)]and the device success rate98(100.0%)vs.98(100.0%)]were not statistically signifi cant(P>0.999).The interval between the two examinations was(5.0±0.5)min.The imaging catheters of the two groups of OCT systems entered and exited the target vessel smoothly.There was no operational failures.No angina pectoris,arrhythmia,dissection,and thrombosis were detected during the inspection.The same target blood vessels were successively examined by domestic OCT system and Light lab C7 OCT system,and clear blood vessel images were obtained.There were no statistically signifi cant diff erence in the ratio of clear imaging length>24 mm96(98.0%)vs.96(98.0%),P>0.999],CIL(41.6±8.8)mm vs.(40.8±9.3)mm,P=0.691],clear scaffold length(20.3±3.8)mm vs.(20.8±3.6)mm,P=0.477],MLD(2.5±0.4)mm vs.(2.6±0.5)mm,P=0.341]and MLA(5.8±2.1)mm^2 vs.(5.9±1.9)mm^2,P=0.859]between the two groups.There were no statistically signifi cant diff erences in coronary arterial microstructural changes,stent margin dissection1(1.0%)vs.1(1.0%)],tissue prolapse42(42.9%)vs.42(42.9%)],and poor wall defects44(44.9%)vs.44(44.9%)]of domestic OCT compared with C7 group(all P>0.999).Conclusions The safety and accuracy of domestic optical coherence tomography system were equal to that of light lab C7 OCT system.