Ito Shigenori, Kinoshita Kanako, Endo Akiko, Kami Ryoko, Kotake Yuko, Nakamura Masato
Division of Cardiology, Sankuro Hospital, 7-80 Kosaka-cho, Toyota-shi, Aichi-ken, 471-0035, Japan.
Japan Cardiovascular Imaging Core Laboratory, Tokyo, Japan.
Ther Adv Cardiovasc Dis. 2020 Jan-Dec;14:1753944720958982. doi: 10.1177/1753944720958982.
To evaluate inter-core laboratory variability of quantitative coronary angiography (QCA) parameters in comparison with intra-core laboratory variability in a randomized controlled trial evaluating drug-eluting stents.
A total of 50 patients with 62 coronary lesions were analyzed by four analysis experts belonging to an Angiographic Core Laboratory (ACL: 1 expert) and a Cardiovascular Imaging Core Laboratory (CICL: 3 experts). QCA was based on the same standard operating procedure, but selections of projection and cine frames were at the discretion of each analyst. Inter- and intra-core laboratory variabilities were evaluated by accuracy, precision, Bland Altman analysis, and coefficient of variation.
Pre-MLD (minimal lumen diameter) was significantly smaller in results from ACL than those from all CICL experts. Number of analyzed projections did not affect pre-MLD results. Acute gain was larger in ACL than in CICL2. No significant difference was observed in late loss and loss index between inter-core laboratories. Agreement between core labs in the Bland-Altman analysis for each QCA parameter was as follows (mean difference, 95% limits of agreement): pre-MLD (-0.32, -0.74 to 0.10), stent MLD (0.08, -0.28 to 0.44), acute gain (0.22, -0.44 to 0.88), and late loss (-0.07, -0.69 to 0.55). Agreement between analysts in CICL (mean difference, 95% limits of agreement) was: pre MLD (-0.03, -0.37 to 0.31), stent MLD (0.15, -0.15 to 0.45), acute gain (0.05, -0.45 to 0.55), and late loss (0.04, -0.52 to 0.60). The widest limits of agreement among three analyses were shown in both analyses. Width of limited agreement in the intra-core laboratory analysis tended to be smaller than the inter-core laboratory analysis with these parameters. Coefficient of variation tended to be larger in lesion length (LL), acute gain, late loss, and loss index in inter- and in intra- core laboratory comparisons.
Inter-core laboratory QCA variability in late loss and loss index analysis could be similar to intra-core laboratory variability, but more strict alignment between core laboratories would be necessary for initial procedural data analysis.
在一项评估药物洗脱支架的随机对照试验中，评估定量冠状动脉造影（QCA）参数在核心实验室之间的变异性，并与核心实验室内的变异性进行比较。
共有50例患者的62处冠状动脉病变由血管造影核心实验室（ACL：1名专家）和心血管影像核心实验室（CICL：3名专家）的4名分析专家进行分析。QCA基于相同的标准操作程序，但投照角度和电影帧的选择由每位分析师自行决定。通过准确性、精密度、布兰德-奥特曼分析和变异系数评估核心实验室间和核心实验室内的变异性。
ACL得出的预最小管腔直径（MLD）结果显著小于所有CICL专家得出的结果。分析的投照角度数量不影响预MLD结果。ACL得出的急性获得值大于CICL2。核心实验室间在晚期丢失和丢失指数方面未观察到显著差异。核心实验室在每个QCA参数的布兰德-奥特曼分析中的一致性如下（平均差异，95%一致性界限）：预MLD（-0.32，-0.74至0.10），支架MLD（0.08，-0.28至0.44），急性获得（0.22，-0.44至0.88），以及晚期丢失（-0.07，-0.69至0.55）。CICL中分析师之间的一致性（平均差异，95%一致性界限）为：预MLD（-0.03，-0.37至0.31），支架MLD（0.15，-0.15至0.45），急性获得（0.05，-0.45至0.55），以及晚期丢失（0.04，-0.52至0.60）。在这两种分析中，三项分析中一致性界限最宽的情况均有体现。在这些参数方面，核心实验室内分析中一致性界限的宽度往往小于核心实验室间分析。在核心实验室间和核心实验室内比较中，病变长度（LL）、急性获得、晚期丢失和丢失指数的变异系数往往更大。
在晚期丢失和丢失指数分析中，核心实验室间的QCA变异性可能与核心实验室内的变异性相似，但对于初始程序数据分析，核心实验室之间需要更严格的一致性。
