Amsterdam Heart Center, Academic Medical Center, Amsterdam, the Netherlands.
Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
JACC Cardiovasc Interv. 2015 Feb;8(2):305-314. doi: 10.1016/j.jcin.2014.12.002.
This study sought to evaluate inter-core lab variability in quantitative coronary angiography (QCA) analysis of bifurcation lesions.
QCA of bifurcation lesions is challenging. To date there are no data available on the inter-core lab variability of bifurcation QCA analysis.
The randomized Tryton IDE (Tryton Pivotal IDE Coronary Bifurcation Trial) compared the Tryton Side Branch Stent (Tryton Medical, Durham, North Carolina) with balloon angioplasty as side branch treatment. QCA was performed in an angiographic subcohort (n = 326) at 9-month follow-up. Inter-core lab variability of QCA analysis between the Cardiovascular Research Foundation and the Cardialysis core labs was evaluated before and after alignment of the used QCA methodology using angiographic data derived from this angiographic follow-up cohort.
In the original analysis, before alignment of QCA methodology, the mean difference between the core labs (bias) was large for all QCA parameters with wide 95% limits of agreement (1.96 × SD of the bias), indicating marked variability. The bias of the key angiographic endpoint of the Tryton trial, in-segment percentage diameter stenosis (%DS) of the side branch, was 5.5% (95% limits of agreement: -26.7% to 37.8%). After reanalysis, the bias of the in-segment %DS of the side branch reduced to 1.8% (95% limits of agreement: -16.7% to 20.4%). Importantly, after alignment of the 2 core labs, there was no longer a difference between both treatment groups (%DS of the side branch: treatment group A vs. group B: 34.4 ± 19.4% vs. 32.4 ± 16.1%, p = 0.340).
Originally, a marked inter-core lab variability of bifurcation QCA analysis was found. After alignment of methodology, inter-core lab variability decreased considerably and impacted angiographic trial results. This latter finding emphasizes the importance of using the same methodology among different core labs worldwide. (Tryton Pivotal Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety & Effectiveness of the Tryton Side Branch Stent Used With DES in Treatment of de Novo Bifurcation Lesions in the Main Branch & Side Branch in Native Coronaries [TRYTON]; NCT01258972).
本研究旨在评估分叉病变定量冠状动脉造影（QCA）分析中的实验室间变异性。
分叉病变的 QCA 分析具有挑战性。迄今为止，尚无关于分叉 QCA 分析的实验室间变异性的数据。
随机 Tryton IDE（Tryton 关键性 IDE 冠状动脉分叉试验）比较了 Tryton 分支支架（Tryton Medical，北卡罗来纳州达勒姆）与球囊血管成形术作为分支处理。在 9 个月的随访中，对血管造影亚组（n=326）进行了 QCA。在使用源自该血管造影随访队列的血管造影数据之前和之后，使用心血管研究基金会和 Cardialysis 核心实验室评估了 QCA 分析之间的实验室间变异性，使用的 QCA 方法进行了校准。
在原始分析中，在 QCA 方法校准之前，所有 QCA 参数的核心实验室之间的平均差异（偏倚）很大，95%一致性界限（偏倚的 1.96×SD）很宽，表明存在明显的变异性。Tryton 试验的关键血管造影终点，即分支的节段内直径狭窄百分比（%DS）的偏倚为 5.5%（95%一致性界限：-26.7%至 37.8%）。重新分析后，分支节段内%DS 的偏倚降低至 1.8%（95%一致性界限：-16.7%至 20.4%）。重要的是，在 2 个核心实验室校准后，两组之间不再存在差异（分支的%DS：治疗组 A 与组 B：34.4±19.4%与 32.4±16.1%，p=0.340）。
最初，发现分叉 QCA 分析的实验室间变异性明显。在方法学校准后，实验室间变异性显著降低，并影响了血管造影试验结果。这一发现强调了在全球不同核心实验室之间使用相同方法的重要性。（Tryton 关键性前瞻性、单盲、随机对照研究，评估在主支和原生冠状动脉中的新分叉病变中使用 DES 治疗时，Tryton 分支支架在治疗中的安全性和有效性[TRYTON]；NCT01258972）。
