A randomised controlled trial to compare two coronary pressure wires using simultaneous measurements in human coronary arteries: the COMET trial

EuroIntervention 2019;14:e1578-e1584 published online October 2018. DOI: 10.4244/EIJ-D-18-00786

Rod H. Stables
Rod Stables1*, DM, FRCP; Mostafa Elguindy1, MBChB, MSc; Ian Kemp1, BA; Zoe Nicholas2, BSc; Christine Mars1, BSc; Liam Mullen1, MBBS, MRCP; Nicholas Curzen2,3, PhD, FRCP
1. Institute of Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool, United Kingdom; 2. Wessex Cardiothoracic Unit, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom; 3. Faculty of Medicine, University of Southampton, Southampton, United Kingdom

Aims: 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).

Methods and results: 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.

Conclusions: We found no significant difference between these wires in terms of safety and performance. Clinical Trials Registration: NCT02578381.

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clinical trialclinical trialsfractional flow reserve
Coronary interventionsOther coronary interventions
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