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Randomized Controlled Trial
. 2020 Dec;13(12):e009183.
doi: 10.1161/CIRCINTERVENTIONS.120.009183. Epub 2020 Dec 4.

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

Yoshinobu Onuma #  1   2 , Norihiro Kogame #  3   4 , Yohei Sotomi  5 , Yosuke Miyazaki  6 , Taku Asano  3 , Kuniaki Takahashi  3 , Hideyuki Kawashima  3 , Masafumi Ono  3 , Yuki Katagiri  3 , Hiroyuki Kyono  7 , Shimpei Nakatani  5 , Takashi Muramatsu  1 , Faisal Sharif  8   9 , Yukio Ozaki  1 , Patrick W Serruys  2   10 , Takayuki Okamura  6 ; OPTIMUM Investigators
Affiliations
Randomized Controlled Trial

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

Yoshinobu Onuma et al. Circ Cardiovasc Interv. 2020 Dec.

Abstract

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.

Keywords: angiography; dilatation; odds ratio; percutaneous coronary intervention; stent.

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Conflict of interest statement

Dr Sotomi reports personal fees from Terumo Corporation, during the conduct of the study; personal fees from Bayer, personal fees from Daiichi-Sankyo, personal fees from Amgen Astellas BioPharma, personal fees from Boehringer Ingelheim, personal fees from Bristole-Myers Squibb, personal fees from Abbott Vascular Japan, personal fees from Boston Scientific Japan, personal fees from Cardinal Health, personal fees from Medtronic, personal fees from Biosensors, outside the submitted work. Dr Muramatsu reports research grants to Fujita Health University from Terumo Corporation, Tokyo, Japan. Dr Ozaki reports research grants to Fujita Health University from Terumo Corporation, Tokyo, Japan. Dr Serruys reports personal fees from Abbott Laboratories, AstraZeneca, Biotronik, GLG Research, Medtronic, Sino Medical Sciences Technology, Société Europa Digital Publishing, Stentys France, Svelte Medical Systems, Philips/Volcano, St Jude Medical, Qualimed, and Xeltis, outside the submitted work. Dr Okamura reports personal fees from Terumo Corporation, during the conduct of the study; personal fees from Abbot Vascular Japan, personal fees from Medtronic, personal fees from Edwards Life Science, personal fees from Boston Scientific Japan, personal fees from Daiichi Sankyo, personal fees from Astellas, personal fees from Boehringer Ingelheim, personal fees from MSD, personal fees from Sanofi, personal fees from Tanabe Mitsubishi, outside the submitted work. The other authors report no conflicts.

Figures

Figure 1.
Figure 1.
Study flow chart. 3D indicates 3-dimensional; ISA, incomplete stent apposition; KBD, kissing balloon dilatation; L, lesion; OFDI, optical frequency domain imaging; PCI, percutaneous coronary intervention; and POT, proximal optimization technique.
Figure 2.
Figure 2.
Representative cases of angiography-guided and online 3-dimensional (3D)-optical frequency domain imaging (OFDI)-guided percutaneous coronary intervention. Sixty-nine-y-old female with Medina 0, 1, 0 left main (LM) bifurcation lesion (diameter stenosis by quantitative coronary angiography: 58% in left anterior descending artery [LAD]) was randomized to the angiography arm (A). A 3.0×15 mm Ultimaster stent (B: yellow dotted line) was implanted in the LM toward proximal LAD, followed by proximal optimization technique (POT) with a 4.0 mm balloon and subsequent wire recrossing to the left circumflex artery. After final kissing balloon dilatation (KBD), 3D-OFDI was performed for documentation purpose, which revealed presence of metallic struts in front of the side branch ostium (C). The frequency of malapposed struts (D: yellow arrow) was 33.9% by cross-sectional OFDI image. Fifty-eight-y-old male with Medina 1, 1, 1, LAD bifurcation lesion was randomized to the 3D-OFDI arm (E). A 3.0×28 mm Ultimaster stent (F: yellow dotted line) was implanted in the LAD followed by POT. After the first attempt of rewiring to the diagonal branch, 3D-OFDI revealed suboptimal position of the wire (A2-S) according to the specific classification (G). According to the protocol, crossing of the wire to the diagonal branch was repeated to achieve optimal wiring through the distal cell. A subsequent OFDI pullback confirmed the optimal position of the recrossing wire (H: A1-L). After KBD, the final OFDI image demonstrated wide opening of the sidebranch ostium without overhanging metallic structure (I and J: yellow arrow indicates malapposed strut).
Figure 3.
Figure 3.
Average percentage of acute incomplete stent apposition per lesion at bifurcation. 3D indicates 3-dimensional; ISA, incomplete stent apposition; L, lesion; and OFDI, optical frequency domain imaging.
See this image and copyright information in PMC

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