Hiromasa Otake1, Takashi Kubo2, Hachidai Takahashi1, Toshiro Shinke1, Takayuki Okamura3, Kiyoshi Hibi4, Gaku Nakazawa5, Yoshihiro Morino6, Junya Shite7, Tetsuya Fusazaki6, Ken Kozuma8, Tetsuya Ioji9, Hideaki Kaneda9, Takashi Akasaka10. 1. Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan. 2. Department of Cardiovascular Medicine, Wakayama Medical University, Wakayama, Japan. 3. Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine, Ube, Japan. 4. Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan. 5. Division of Cardiology, Tokai University School of Medicine, Isehara, Japan. 6. Division of Cardiology, Iwate Medical University, Morioka, Japan. 7. Division of Cardiology, Osaka Saiseikai Nakatsu Hospital, Osaka, Japan. 8. Division of Cardiology, Teikyo University School of Medicine, Tokyo, Japan. 9. Translational Research Informatics Center, Kobe, Japan. 10. Department of Cardiovascular Medicine, Wakayama Medical University, Wakayama, Japan. Electronic address: akasat@wakayama-med.ac.jp.
Abstract
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 eitherOFDI-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).
RCT Entities:
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).