Author + information
- Received April 12, 2017
- Revision received June 2, 2017
- Accepted June 8, 2017
- Published online January 1, 2018.
- Hiromasa Otake, MDa,
- Takashi Kubo, MDb,
- Hachidai Takahashi, MDa,
- Toshiro Shinke, MDa,
- Takayuki Okamura, MDc,
- Kiyoshi Hibi, MDd,
- Gaku Nakazawa, MDe,
- Yoshihiro Morino, MDf,
- Junya Shite, MDg,
- Tetsuya Fusazaki, MDf,
- Ken Kozuma, MDh,
- Tetsuya Ioji, MSi,
- Hideaki Kaneda, MDi,
- Takashi Akasaka, MDb,∗ (, )
- on behalf of the OPINION Investigators
- aDivision of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan
- bDepartment of Cardiovascular Medicine, Wakayama Medical University, Wakayama, Japan
- cDivision of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine, Ube, Japan
- dDivision of Cardiology, Yokohama City University Medical Center, Yokohama, Japan
- eDivision of Cardiology, Tokai University School of Medicine, Isehara, Japan
- fDivision of Cardiology, Iwate Medical University, Morioka, Japan
- gDivision of Cardiology, Osaka Saiseikai Nakatsu Hospital, Osaka, Japan
- hDivision of Cardiology, Teikyo University School of Medicine, Tokyo, Japan
- iTranslational Research Informatics Center, Kobe, Japan
- ↵∗Address for correspondence:
Dr. Takashi Akasaka, Department of Cardiovascular Medicine, Wakayama Medical University, 811-1 Kimiidera, Wakayama 641-8509, Japan.
Objectives The authors sought to clarify how intravascular ultrasound (IVUS) and optical coherence tomography affect percutaneous coronary intervention (PCI) with current-generation drug-eluting stents in a pre-specified substudy of the OPINION (OPtical frequency domain imaging versus INtravascular ultrasound in percutaneous coronary interventiON) trial, a multicenter, prospective, randomized, noninferiority trial comparing optical frequency domain imaging (OFDI)-guided PCI with IVUS-guided PCI.
Background The impact of these 2 imaging modalities in guiding PCI remains unknown.
Methods Of 829 patients enrolled in the OPINION trial, 106 were included in the present imaging substudy. Their PCI was guided by either IVUS or OFDI, but all patients were imaged by both modalities after PCI and by OFDI at 8 months. Angiographic, OFDI, and IVUS images were analyzed by independent core laboratories, and statistical analysis was done independently by a dedicated institution.
Results A total of 103 patients underwent either OFDI-guided (n = 54) or IVUS-guided (n = 49) PCI. Immediately after PCI, OFDI-guided PCI was associated with a smaller trend of minimum stent area (5.28 ± 1.65 mm2 vs. 6.12 ± 2.34 mm2; p = 0.088), fewer proximal stent-edge hematomas (p = 0.04), and fewer irregular protrusions (p = 0.014) than IVUS-guided PCI. At 8 months, the neointima area tended to be smaller in the OFDI-guided PCI group than in the IVUS-guided PCI group (0.56 ± 0.30 mm2 vs. 0.80 ± 0.65 mm2; p = 0.057), although the percentage of uncovered struts was significantly higher in the OFDI-guided PCI group than in the IVUS-guided PCI group (6.97 ± 7.03% vs. 4.67 ± 6.43%; p = 0.039). The minimum lumen area was comparable in both groups (p = 0.18).
Conclusions There were several differences in local findings between OFDI- and IVUS-guided PCI as expected given the different protocols for stent sizing in the 2 groups. The minimum lumen area at the 8-month follow-up was comparable, suggesting that OFDI- and IVUS-guided PCI are similarly feasible using the current-generation drug-eluting stents. (OPtical frequency domain imaging versus INtravascular ultrasound in percutaneous coronary interventiON; NCT01873222)
- intravascular ultrasound
- optical coherence tomography
- optical frequency domain imaging
- percutaneous coronary intervention
This work is supported by a grant from Terumo Corporation. However, the company was not involved in the design, data collection, data analysis, data interpretation, writing of the report, or the decision to submit the paper for publication. Drs. Kubo, Shinke, and Shite have received lecture fees from Terumo Corporation. Dr. Akasaka has received lecture fees and research funds from Terumo Corporation. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received April 12, 2017.
- Revision received June 2, 2017.
- Accepted June 8, 2017.
- 2018 The Authors