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Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): one-year angiographic and clinical results

Open access
Kubo, Takashi, Shinke, Toshiro, Okamura, Takayuki, Hibi, Kiyoshi, Nakazawa, Gaku, Morino, Yoshihiro, Shite, Junya, Fusazaki, Tetsuya, Otake, Hiromasa, Kozuma, Ken, Ioji, Tetsuya, Kaneda, Hideaki, Serikawa, Takeshi, Kataoka, Toru, Okada, Hisayuki, Akasaka, Takashi, OPINION Investigators·2017·European Heart Journal

Abstract

AIMS: Optical frequency domain imaging (OFDI) is a recently developed, light-based, high-resolution intravascular imaging technique. Intravascular ultrasound (IVUS) is a widely used, conventional imaging technique for guiding percutaneous coronary intervention (PCI). We aimed to demonstrate the non-inferiority of OFDI-guided PCI compared with IVUS-guided PCI in terms of clinical outcomes. METHODS AND RESULTS: We did a prospective, multicentre, randomized (ratio 1:1), active-controlled, non-inferiority study to compare head-to-head OFDI vs. IVUS in patients undergoing PCI with a second generation drug-eluting stent. The primary endpoint was target vessel failure defined as a composite of cardiac death, target-vessel related myocardial infarction, and ischaemia-driven target vessel revascularization until 12 months after the PCI. The major secondary endpoint was angiographic binary restenosis at 8 months. We randomly allocated 829 patients to receive OFDI-guided PCI (n = 414) or IVUS-guided PCI (n = 415). Target vessel failure occurred in 21 (5.2%) of 401 patients undergoing OFDI-guided PCI, and 19 (4.9%) of 390 patients undergoing IVUS-guided PCI, demonstrating non-inferiority of OFDI-guided PCI to IVUS-guided PCI (hazard ratio 1.07, upper limit of one-sided 95% confidence interval 1.80; Pnon-inferiority = 0.042). With 89.8% angiographic follow-up, the rate of binary restenosis was comparable between OFDI-guided PCI and IVUS-guided PCI (in-stent: 1.6% vs. 1.6%, P = 1.00; and in-segment: 6.2% vs. 6.0%, P = 1.00). CONCLUSION: The 12-month clinical outcome in patients undergoing OFDI-guided PCI was non-inferior to that of patients undergoing IVUS-guided PCI. Both OFDI-guided and IVUS-guided PCI yielded excellent angiographic and clinical results, with very low rates of 8-month angiographic binary restenosis and 12-month target vessel failure. CLINICAL REGISTRATION: ClinicalTrials.gov, number NCT01873027.

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Metadata

Authors
Kubo, T., Shinke, T., Okamura, T., Hibi, K., Nakazawa, G., Morino, Y., Shite, J., Fusazaki, T., Otake, H., Kozuma, K., Ioji, T., Kaneda, H., Serikawa, T., Kataoka, T., Okada, H., Akasaka, T., & OPINION Investigators
Venue
European Heart Journal
Published
2017-06-27
Volume
38
Issue
42
Pages
3139-3147
ISSN
  • 0195-668X (ISSN-L)
  • 1522-9645
OpenAlex
W2729505993
Cited by
288
References
7
FWCI
21.73
Type
journal article
Language
en
Open access
hybrid

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Kubo, T., Shinke, T., Okamura, T., Hibi, K., Nakazawa, G., Morino, Y., Shite, J., Fusazaki, T., Otake, H., Kozuma, K., Ioji, T., Kaneda, H., Serikawa, T., Kataoka, T., Okada, H., Akasaka, T., & OPINION Investigators. (2017). Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): one-year angiographic and clinical results. European Heart Journal. https://doi.org/10.1093/eurheartj/ehx351

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