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低分辨率限制和不准确的算法显著降低了当前药物洗脱支架试验中晚期丢失的价值。

Low resolution limits and inaccurate algorithms decrease significantly the value of late loss in current drug-eluting stent trials.

作者信息

Dahm Johannes B, van Buuren Frank

机构信息

Department of Cardiology-Angiology, Heart and Vascular Center Neu-Bethlehem, Humboldtallee 6, 37073 Göttingen, Germany.

出版信息

Int J Vasc Med. 2012;2012:417250. doi: 10.1155/2012/417250. Epub 2012 Mar 20.

Abstract

Quantitative coronary and vascular angiography (QCA resp., QVA) remains the current gold standard for evaluation of restenosis. Late loss as one of the most commonly accepted parameters to highlight efficacy of the various devices has shown high correlation to clinical parameters but, surprisingly, has no impact on the evaluation of the remaining amount of restenostic tissue. The current clinical practice leads to unrealistic late loss calculations. Smaller late loss differences are usually not greater than the inherited resolution limits of QCA, which is especially the case in small differences between the various stents in the drug-eluting stent era. Late loss include additional systematic and random errors, due to the fact that measurements were taken at two different time points including the inherited resolution and calibration limits of QCA on two occasions. Due to the limited value of late loss in discriminating the small differences between the one and other DES, late lumen area loss and clearly defined calculation algorithms (e.g., MLD-relocation) should be used in future DES studies also to fulfill the more stringent regulatory requirements.

摘要

定量冠状动脉造影和血管造影(分别为QCA和QVA)仍然是评估再狭窄的当前金标准。晚期管腔丢失作为突出各种器械疗效的最常用参数之一,已显示出与临床参数高度相关,但令人惊讶的是,它对再狭窄组织剩余量的评估没有影响。当前的临床实践导致晚期管腔丢失的计算不切实际。较小的晚期管腔丢失差异通常不大于QCA固有的分辨率极限,在药物洗脱支架时代各种支架之间的微小差异中尤其如此。晚期管腔丢失包括额外的系统误差和随机误差,这是因为测量是在两个不同时间点进行的,包括两次QCA的固有分辨率和校准极限。由于晚期管腔丢失在区分不同药物洗脱支架之间的微小差异方面价值有限,未来的药物洗脱支架研究也应使用晚期管腔面积丢失和明确的计算算法(如MLD重新定位),以满足更严格的监管要求。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c84/3317211/a7d47287a47f/IJVM2012-417250.001.jpg

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