scholarly journals A Randomized Trial Evaluating Online 3-Dimensional Optical Frequency Domain Imaging–Guided Percutaneous Coronary Intervention in Bifurcation Lesions

Author(s):  
Yoshinobu Onuma ◽  
Norihiro Kogame ◽  
Yohei Sotomi ◽  
Yosuke Miyazaki ◽  
Taku Asano ◽  
...  

Background: Clinical implications of online 3-dimensional optical frequency domain imaging (3D-OFDI)-guided stenting for bifurcation lesions have not been investigated in the randomized controlled trials. The purpose of this study was to determine whether online 3D-OFDI-guided stenting is superior to angiography-guided percutaneous coronary intervention (PCI) in terms of incomplete stent apposition at the bifurcation segment. Methods: The OPTIMUM trial (Online 3-Dimensional Optical Frequency Domain Imaging to Optimize Bifurcation Stenting Using UltiMaster Stent) was a randomized, multicenter clinical trial. Eligible patients had an angiographically significant stenosis in the bifurcation lesion treated with a provisional single stent strategy using the Ultimaster sirolimus eluting stent. Patients were randomly allocated to either online 3D-OFDI-guided or angiography-guided PCI. Patients randomized to 3D-OFDI guidance underwent online 3D-OFDI assessment after rewiring into the jailed side branch after stenting and proximal optimization technique, while in the angiography guidance arm, rewiring was performed using conventional fluoroscopic/angiographic guidance. The primary end point of this trial was the postprocedural average percentage of malapposed struts per lesion assessed by OFDI in the confluence zone of the main and side branches. Results: Between June 8, 2017 and September 26, 2018, 110 patients with 111 bifurcation lesions were randomized at 4 Japanese centers. Of these, 56 patients with 57 lesions were treated with 3D-OFDI-guided PCI, whereas 54 patients with 54 lesions were treated with angiography-guided PCI. In the 3D-OFDI guidance arm, the feasibility of online 3D-OFDI was 98.2%. The average percentage of incomplete stent apposition per lesion at bifurcation was lower in the 3D-OFDI guidance arm than that in the angiography guidance arm (19.5±15.8% versus 27.5±14.2%, P =0.008). The superiority of the 3D-OFDI guidance arm was also confirmed in the strut level analysis (odds ratio: 0.54 [95% CI, 0.36–0.81]; P =0.003). Conclusions: Online 3D-OFDI-guided bifurcation PCI was superior to angiography-guided bifurcation PCI in terms of acute incomplete stent apposition at bifurcation. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02972489.

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
V Roule ◽  
L Schwob ◽  
A Lemaitre ◽  
M Bignon ◽  
P Ardouin ◽  
...  

Abstract Background The clinical significance of residual in-stent atherothrombotic burden (ATB) after primary percutaneous coronary intervention (PCI) remains unclear. Several methods of ATB quantification using optical frequency domain imaging (OFDI) exist. Objectives We aimed to assess the relationship between residual ATB after primary PCI measured in OFDI using different methods and myocardial blush grade (MBG). Methods We prospectively included 60 ST-elevation myocardial infarction patients pre-treated with aspirin and ticagrelor. OFDI volumetric quantification using planimetry (with intervals every frame or every millimeter) and semi-quantitative score were used to determine ATB. Patients were divided into two groups according to final MBG 3 or <3. Results MBG 3 was identified in 28 (46%) patients. Altogether, 13318 OFDI cross-sections were analyzed. The mean ATB was 10.08±5.21%. ATB was lower in patients with normal final MBG compared to those with impaired MBG, regardless of the method used (8.15±5.58 vs 11.77±4.28%; p=0.007 for quantification per frame; 7.8±5.19 vs 11.07±4.07%; p=0.009 for quantification per mm and 11.21±11.75 vs 22.91±17.35; p=0.003 for the semi-quantitative thrombus score, respectively). Table 1. Post stenting OFDI findings OFDI measures All Final Blush <3 Final Blush 3 p n=60 (100%) n=32 (53%) n=28 (47%) Stent volume (mm3) 219.42±135.76 226.08±168.69 211.82±86.57 0.68 Evaluation per frame   Atherothrombotic volume (mm3) 21.66±16.81 25.83±18.86 16.89±12.83 0.035   Atherothrombotic burden (%) 10.08±5.21 11.77±4.28 8.15±5.58 0.007 Evaluation per millimeter   Atherothrombotic volume (mm3) 20.71±16.16 24.57±18.15 16.29±12.43 0.042   Atherothrombotic burden (%) 9.5±4.88 11.07±4.07 7.8±5.19 0.009 Thrombus score 17.45±16 22.91±17.35 11.21±11.75 0.003 Optical frequency domain imaging example Conclusion Residual post-stenting ATB remains substantial after primary PCI in STEMI patients, even when pre-treated with ticagrelor and aspirin. Mostly, it appears as an important surrogate of clinical outcome as patients with normal myocardial reperfusion presented lower residual ATB.


2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Vincent Roule ◽  
Idir Rebouh ◽  
Adrien Lemaitre ◽  
Mathieu Bignon ◽  
Pierre Ardouin ◽  
...  

Objectives. We aimed to assess the quality of optical frequency domain imaging (OFDI) of the left main (LM) arterial wall and describe and analyse potential artefacts in this setting. Background. OFDI is increasingly used to assess ambiguous lesions and optimize LM percutaneous coronary intervention. However, its ability to provide artefact-free high-quality images of coronary ostia and large segments such as the LM remains uncertain. Methods. We included 42 consecutive patients who underwent OFDI, including LM imaging. Each OFDI frame was subdivided into four quadrants and analysed. The number of quadrants with artifacts was calculated within the proximal, mid, and distal LM and the first 5 mm of the left anterior descending artery (LAD) and/or left circumflex artery (LCX). Results. The quadrants analysis showed an overall artifact rate of 8.9%, mostly out-of-field (45.1%) or residual blood (44.7%) artefacts. Most artifacts were located in the proximal LM (18.6%) with a stepwise reduction of artifact rates towards distal segments (mid LM 5.8%; distal LM 3.6%, ostial LAD 2.6%, and ostial LCX 0%; p<0.001). While 20 (48.8%) patients had angiographically visible plaques, OFDI showed plaques in 32 patients (76.2%; p=0.007). Conclusion. OFDI can accurately evaluate the LM and detect and assess angiographically unvisualized atherosclerotic plaques providing accurate assessment of >90% of the quadrants of the LM and the ostia of its bifurcation branches. However, artifacts mainly located in the proximal LM and decreasing distally in a stepwise fashion should be considered in the interpretation of OFDI in this setting.


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