Institute of Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool, United Kingdom.
EuroIntervention. 2019 Feb 8;14(15):e1578-e1584. doi: 10.4244/EIJ-D-18-00786.
We aimed to examine the relative performance of the new COMET wire from Boston Scientific (BS), and the established technology from St. Jude/Abbott Vascular (SJ).
We compared simultaneous readings from pairs of wires. Patients were randomised to one of three groups: BS/BS, SJ/SJ, or SJ/BS. The last group was sub-randomised to specify the type of wire that would be passed first. After pressure equalisation at the guide catheter, we recorded paired observations in sequence: (a) distal to proximal pressure ratio at baseline, (b) FFR at maximum hyperaemia, and (c) pressure on withdrawal into the guide catheter to quantify "drift". We randomised 106 patients, yielding 288 sets of paired recordings (BS/BS=90; SJ/SJ=90; SJ/BS=108). Drift was recorded from 208 vessels (BS=105; SJ=103). All wires were successfully advanced to their desired positions in the coronary vasculature. The mean (±SD) differences for the randomised pairs were similar: BS/BS=0.0016 (0.023); SJ/SJ=0.002 (0.03); SJ/BS=0.0013 (0.028). The primary outcome tested the hypothesis that the absolute magnitude of the difference (irrespective of sign) observed in the SJ/BS pairing would be similar to that in the SJ/SJ group. The median (IQR) values were SJ/BS=0.015 (0.01-0.03); SJ/SJ=0.01 (0.00-0.03); p=0.61. The drift, expressed as the median (IQR) difference in Pd/Pa from 1.0 (irrespective of sign), was similar: BS=0.02 (0.01-0.05); SJ=0.02 (0.01-0.04); p=0.14.
We found no significant difference between these wires in terms of safety and performance.
我们旨在检验波士顿科学公司（BS）的新型 COMET 导丝和圣犹达/雅培血管（SJ）的成熟技术的相对性能。
我们比较了成对导丝的同步读数。患者被随机分配到三组之一：BS/BS、SJ/SJ 或 SJ/BS。后一组被进一步随机分配，以指定首先通过的导丝类型。在导引导管中进行压力平衡后，我们依次记录成对观察结果：（a）在基线时远端至近端压力比，（b）最大充血时的 FFR，以及（c）导引导管内撤回时的压力，以量化“漂移”。我们随机化了 106 名患者，产生了 288 对配对记录（BS/BS=90；SJ/SJ=90；SJ/BS=108）。从 208 个血管（BS=105；SJ=103）中记录了漂移。所有导丝都成功地推进到冠状动脉中的所需位置。随机配对的平均（±SD）差异相似：BS/BS=0.0016（0.023）；SJ/SJ=0.002（0.03）；SJ/BS=0.0013（0.028）。主要结局检验了这样一个假设，即 SJ/BS 配对中观察到的差异（不论符号如何）的绝对值与 SJ/SJ 组相似。中位数（IQR）值为 SJ/BS=0.015（0.01-0.03）；SJ/SJ=0.01（0.00-0.03）；p=0.61。漂移，以 Pd/Pa 从 1.0 （不论符号如何）的中位数（IQR）差异表示，相似：BS=0.02（0.01-0.05）；SJ=0.02（0.01-0.04）；p=0.14。
就安全性和性能而言，我们没有发现这些导丝之间有显著差异。
