当地研究者、血管造影核心实验室和临床事件委员会在评估支架血栓形成方面缺乏一致性：来自 TRACER 血管造影子研究的结果。
Lack of Concordance Between Local Investigators, Angiographic Core Laboratory, and Clinical Event Committee in the Assessment of Stent Thrombosis: Results From the TRACER Angiographic Substudy.
机构信息
From the Division of Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA (C.J.P., S.K., Y.D., G.C., C.M.G.); Department of Vascular Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China (S.S.); Duke Clinical Research Institute, Durham, NC (P.T., Z.H.); Department of Medicine, Gill Heart Institute, University of Kentucky, Lexington (D.J.M.); Department of Cardiology, Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Department of Cardiology, University of Leuven, Leuven, Belgium (F.V.d.W.); Department of Medicine, Stanford University, CA (R.A.H., K.W.M.); Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (L.W., C.H.); Division of Cardiology, Department of Medicine, University of Alberta, Edmonton, Canada (P.W.A.); Cardiac and Critical Care Services, Department of Medicine, South Australian Health and Medical Research Institute, Flinders University and Medical Centre, Adelaide, Australia (P.E.A.); and Merck Clinical Research, Merck & Co, Whitehouse Station, NJ (J.S.).
出版信息
Circ Cardiovasc Interv. 2016 May;9(5):e003114. doi: 10.1161/CIRCINTERVENTIONS.115.003114.
BACKGROUND
Stent thrombosis (ST) is an important end point in cardiovascular clinical trials. Adjudication is traditionally based on clinical event committee (CEC) review of case report forms and source documentation rather than angiograms. However, the degree to which this method of adjudication is concordant with the review of independent angiographic core laboratories (ACLs) has not been studied. This report represents the first assessment of variability between local investigators (LIs), a CEC, and an ACL.
METHODS AND RESULTS
Serial angiograms of 329 patients with acute coronary syndrome without ST-segment-elevation who underwent percutaneous coronary intervention at entry in the Trial to Assess the Effects of Vorapaxar in Preventing Heart Attack and Stroke in Particpants With Acute Coronary Syndrome (TRACER) and who met criteria for possible ST subsequent to the index event were reviewed by an ACL. The ACL was blinded to the assessment by both LIs and the CEC regarding the presence or absence of ST. CEC adjudication was based on Academic Research Consortium definitions of ST, using case report form data and source documents, including catheterization laboratory reports. The ACL, CEC, and LIs agreed on the presence or absence of ST in 52.9% events (κ=0.32; 95% confidence interval, 0.26-0.39). The ACL and CEC agreed on 82.7% of events (κ=0.57; 95% confidence interval, 0.47-0.67); the ACL and LIs agreed on 61.1% of events (κ=0.25; 95% confidence interval, 0.16-0.34); and the CEC and LIs agreed on 62% of events (κ=0.28; 95% confidence interval, 0.21-0.36).
CONCLUSIONS
ST reporting by an ACL, a CEC, and LIs is discordant. The assessment of ST is more often detected by direct review of angiograms by an ACL.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00527943.
背景
支架血栓形成（ST）是心血管临床试验中的一个重要终点。传统上，裁决是基于临床事件委员会（CEC）对病例报告表和源文件的审查，而不是血管造影。然而，这种裁决方法与独立血管造影核心实验室（ACLs）的审查相符的程度尚未得到研究。本报告代表了对当地研究者（LI）、CEC 和 ACL 之间变异性的首次评估。
方法和结果
在急性冠脉综合征无 ST 段抬高的患者中，329 例患者在接受经皮冠状动脉介入治疗时进入了评估Vorapaxar 在急性冠脉综合征患者中预防心脏病发作和中风的效果的试验（TRACER），并且在指数事件后符合可能发生 ST 的标准。对这些患者进行了血管造影核心实验室（ACLs）的审查。ACLs 对 LI 和 CEC 对 ST 是否存在的评估均不知情。CEC 的裁决基于 ST 的学术研究联盟定义，使用病例报告表数据和源文件，包括导管实验室报告。ACLs、CEC 和 LI 对 52.9%的事件是否存在 ST 达成一致（κ=0.32；95%置信区间，0.26-0.39）。ACLs 和 CEC 对 82.7%的事件达成一致（κ=0.57；95%置信区间，0.47-0.67）；ACLs 和 LI 对 61.1%的事件达成一致（κ=0.25；95%置信区间，0.16-0.34）；CEC 和 LI 对 62%的事件达成一致（κ=0.28；95%置信区间，0.21-0.36）。
结论
ACLs、CEC 和 LI 对 ST 的报告不一致。ST 的评估更常通过 ACL 对血管造影的直接审查来发现。
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