From the Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (A.K.C., C.M.G.); PERFUSE Angiographic Core Laboratories and Data Coordinating Center, Beth Israel Deaconess Medical Center, Boston, MA (A.K.C., C.A., C.M.G.); Duke Clinical Research Institute, Duke University, Durham, NC (M.V.G.-S., S.O., E.D., E.P.); American College of Cardiology, Washington, DC (A.P.); Division of Internal Medicine, Department of Medicine, Rush University, Chicago, IL (L.W.K.); Northshore-LIJ/Lenox Hill Hospital, New York, NY (K.N.G.); and Christiana Care Health System, Newark, DE (W.S.W.).
Circ Cardiovasc Interv. 2014 Feb;7(1):11-8. doi: 10.1161/CIRCINTERVENTIONS.113.000679. Epub 2014 Feb 4.
The goal of this study was to compare angiographic interpretation of coronary arteriograms by sites in community practice versus those made by a centralized angiographic core laboratory.
The study population consisted of 2013 American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR) records with 2- and 3- vessel coronary disease from 54 sites in 2004 to 2007. The primary analysis compared Registry (NCDR)-defined 2- and 3-vessel disease versus those from an angiographic core laboratory analysis. Vessel-level kappa coefficients suggested moderate agreement between NCDR and core laboratory analysis, ranging from kappa=0.39 (95% confidence intervals, 0.32-0.45) for the left anterior descending artery to kappa=0.59 (95% confidence intervals, 0.55-0.64) for the right coronary artery. Overall, 6.3% (n=127 out of 2013) of those patients identified with multivessel disease at NCDR sites had had 0- or 1-vessel disease by core laboratory reading. There was no directional bias with regard to overcall, that is, 12.3% of cases read as 3-vessel disease by the sites were read as <3-vessel disease by the core laboratory, and 13.9% of core laboratory 3-vessel cases were read as <3-vessel by the sites. For a subset of patients with left main coronary disease, registry overcall was not linked to increased rates of mortality or myocardial infarction.
There was only modest agreement between angiographic readings in clinical practice and those from an independent core laboratory. Further study will be needed because the implications for patient management are uncertain.
本研究的目的是比较社区实践中站点的冠状动脉造影血管造影解读与集中的血管造影核心实验室的解读。
研究人群由 2004 年至 2007 年来自 54 个地点的 2013 例美国心脏病学会-国家心血管数据注册（ACC-NCDR）的 2 支和 3 支血管病变记录组成。主要分析比较了注册（NCDR）定义的 2 支和 3 支血管病变与血管造影核心实验室分析的结果。血管水平的 Kappa 系数表明 NCDR 和核心实验室分析之间存在中度一致性，范围从左前降支的 Kappa=0.39（95%置信区间，0.32-0.45）到右冠状动脉的 Kappa=0.59（95%置信区间，0.55-0.64）。总体而言，在 NCDR 站点确定患有多支血管病变的患者中，有 6.3%（2013 例中有 127 例）通过核心实验室阅读为 0 支或 1 支血管病变。没有关于过诊的方向性偏差，即站点读取的 12.3%的 3 支血管病变病例被核心实验室读取为<3 支血管病变，而核心实验室的 13.9%的 3 支血管病变病例被站点读取为<3 支血管病变。对于一组左主干冠状动脉疾病患者，注册过诊与死亡率或心肌梗死增加无关。
临床实践中的血管造影读数与独立核心实验室的读数之间仅存在适度的一致性。需要进一步研究，因为这对患者管理的影响尚不确定。
