Moer Rasmus, van Weert Anton W M, Myreng Yngvar, Mølstad Per
Department of Cardiology, The Feiring Heart Clinic, Feiring, Norway.
Int J Cardiovasc Imaging. 2003 Dec;19(6):457-64. doi: 10.1023/b:caim.0000004327.52633.d2.
To assess the validity of locally performed off-line quantitative coronary angiography (QCA) measurement in clinical trials, we carried out a comparative study between on-site QCA analysis and analysis performed at an independent external core laboratory. One local operator analyzed the pre, post and follow-up angiograms of 116 patients participating in the Stenting in Small Coronary Arteries Study (SISCA) prior to final QCA analysis in the core laboratory. The mean values of the reference diameter (RD), minimal lumen diameter (MLD) and diameter stenosis (DS) showed acceptable agreement between study site and core laboratory. However, on the level of individuals the interobserver differences were large, affecting the outcome of restenosis rate significantly, and in a such way that the conclusions in the SISCA trial might have come out differently if a core laboratory had not been used. This emphasizes the importance of using independent core laboratories in coronary interventional trials.
为评估在临床试验中本地进行的离线定量冠状动脉造影（QCA）测量的有效性，我们在现场QCA分析与独立外部核心实验室进行的分析之间开展了一项对比研究。在核心实验室进行最终QCA分析之前，一名本地操作人员分析了参与小冠状动脉支架置入研究（SISCA）的116例患者的术前、术后及随访血管造影。参考直径（RD）、最小管腔直径（MLD）和直径狭窄（DS）的平均值在研究地点与核心实验室之间显示出可接受的一致性。然而，在个体层面，观察者间差异很大，显著影响了再狭窄率的结果，并且如果未使用核心实验室，SISCA试验的结论可能会有所不同。这强调了在冠状动脉介入试验中使用独立核心实验室的重要性。
