血管造影实验室、临床事件委员会及临床医生对诊断冠脉支架后血栓的一致性研究

发布时间：2018-02-28 12:04

本文关键词： 支架后血栓形成临床事件委员会血管造影实验室 TRACER实验急性冠脉综合症　出处：《华中科技大学》2015年博士论文　论文类型：学位论文

【摘要】：实验目的：探讨研究临床事件委员会,血管造影实验室,及临床医生判断对支架后血栓形成这一事件的诊断结果的一致性实验背景：在急性冠脉综合症的患者中,通过介入术为患者安装冠脉支架已经成为广泛接受并使用的治疗方案。支架后血栓形成是一个少见但是后果十分严重的并发症,但随着支架的使用越来越广泛,这一少见并发症也引起了越来越多的关注,许多大型临床研究中将其作为常见的用来评估安全性或有效性的终点事件。其发生率的高低直接说明临床实验中所使用药物或者支架对于患者预后的影响。由于经验等原因,不同机构和阅片者对血管造影结果解读存在一定的主观性,导致ST的诊断结果不够稳定,因此需要重新审查所有急性的病例来确定ST确实是血管再次堵塞的原因。临床病例委员会(CECs),通常在临床研究中对案例和终点事件提供独立和双盲的分析,比如支架后血栓形成。尽管对支架后血栓形成的诊断有严格的定义,在血管造影实验室(ACL)CEC以及临床医生三者之间做出的判断依然存在偏差,其程度尚未确定。实验方法：以TRACER临床研究的病例作为分析数据来源,CEC采用学术研究联合会(Academic research consortium.ARC)推荐的标准及TIMI分级作为诊断支架后血栓形成的标准,ACL采用TIMI血流分级和TIMI心肌灌注分级直接对病例的造影影片进行分析,使用plusplus专业冠脉分析软件对每部影片进行精确定量和定性分析。实验数据采用kappa检验来分析三者的异同。实验结果：对收入分析的329名患者,临床医生诊断为ST的是182例(55.3%),ACL判断有ST的是108例(32.8%),CEC判断有ST的是71例(21.6%),被三者都诊断为ST是55例(16.7%)。三者判断不相同的是119例(36.2%)。统计分析后发现,三者结果一致性较差。两个不同研究者之间进行比较,除了CEC和ACL之间存在中等的一致性之外,CEC和临床医生间及ACL和临床研究中相比,其一致性都较差。讨论：支架后血栓形成的诊断具有一定难度,常常会引起误诊或者漏诊。特别是对当CEC无法获得血管造影的原始数据时,其对支架后血栓形成的诊断能力是有限的,主要表现为敏感度不够；血管造影实验室提供的结果能够帮助CEC与介入术中判断达到更好的一致性。临床医生由于各种原因,也无法保证其能对ST做出准确及时的诊断,这可能会影响相关患者获得及时的治疗。本研究的结果提示,对于怀疑ST的患者,如果能有有专门的ACL进行重新判读,能明显提高诊断的准确性。对于临床医生,本研究的结果表明他们常常会过度诊断ST,主要表现为特异性不够。因此在对ST进行诊断时,应该更加的谨慎以免误诊。
[Abstract]:Objective: to explore the consistency of the clinical events committee, the angiography laboratory, and the clinicians in the diagnosis of this event: in patients with acute coronary syndrome, Implantation of coronary stents through interventional procedures has become a widely accepted and used treatment. Retrostenting thrombosis is a rare but serious complication, but with the increasing use of stents, This rare complication has also attracted more and more attention. In many large clinical studies, it is regarded as a common endpoint event to evaluate safety or efficacy. Its incidence directly indicates the influence of drugs or stents used in clinical trials on the prognosis of patients. There is some subjectivity in the interpretation of angiographic results among different organizations and film readers, which leads to the unstable diagnosis of St. Therefore, all acute cases need to be re-examined to determine whether St is indeed the cause of the re-blockage of blood vessels. The Clinical cases Committee usually provides an independent and double-blind analysis of cases and endpoint events in clinical studies. For example, post-stent thrombosis. Despite the strict definition of the diagnosis of post-stent thrombosis, there is still a bias between the ACLCEC in the angiography lab and the clinicians. The extent of the study was not determined. Experimental methods: the TRACER clinical study cases were used as the source of analysis data, the academic research consortium.ARCrecommended by the academic research Association and the TIMI grade as the criteria for the diagnosis of post-stent thrombosis. TIMI was used as the standard for the diagnosis of post-stent thrombosis. Blood flow classification and TIMI myocardial perfusion grade were used to analyze the angiographic films of the patients directly. Accurate quantitative and qualitative analysis of each film was carried out using plusplus professional coronary analysis software. The experimental data were analyzed by kappa test. The clinical doctors diagnosed St in 182 cases (55.3% ACL), 108 cases (32. 8%) were diagnosed as St and 71 cases (21. 6%) were diagnosed as St, and all 3 cases were diagnosed as St in 55 cases (16. 7%). The difference among them was 119 cases (36. 2%). In addition to the moderate consistency between CEC and ACL, they were compared with clinicians and between ACL and clinical studies. Discussion: the diagnosis of thrombus behind stent is difficult and often causes misdiagnosis or misdiagnosis, especially when CEC is unable to obtain the original data of angiography. Its ability to diagnose post-stent thrombosis is limited, mainly due to its lack of sensitivity. The results provided by the angiography laboratory can help to achieve better consistency between CEC and interventional judgment. There is no guarantee of accurate and timely diagnosis of St, which may affect the patient's access to timely treatment. The results of this study suggest that for patients suspected of St, if there is a specific ACL for reinterpretation, The results of this study show that the clinicians often overdiagnose STs, mainly because of their lack of specificity. Therefore, we should be more careful to avoid misdiagnosis in the diagnosis of St.
【学位授予单位】：华中科技大学
【学位级别】：博士
【学位授予年份】：2015
【分类号】：R541.4

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