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Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINIONtrial): one-year angiographic and clinical resultsOptical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINIONtrial): one-year angiographic and clinical results |
"/Kubo, Takashi/"Kubo, Takashi ,
"/Shinke, Toshiro/"Shinke, Toshiro ,
"/Okamura, Takayuki/"Okamura, Takayuki ,
"/Hibi, Kiyoshi/"Hibi, Kiyoshi ,
"/Nakazawa, Gaku/"Nakazawa, Gaku ,
"/Morino, Yoshihiro/"Morino, Yoshihiro ,
"/Shite, Junya/"Shite, Junya ,
"/Fusazaki, Tetsuya/"Fusazaki, Tetsuya ,
"/Otake, Hiromasa/"Otake, Hiromasa ,
"/Kozuma, Ken/"Kozuma, Ken ,
"/Ioji, Tetsuya/"Ioji, Tetsuya ,
"/Kaneda, Hideaki/"Kaneda, Hideaki ,
"/Serikawa, Takeshi/"Serikawa, Takeshi ,
"/Kataoka, Toru/"Kataoka, Toru ,
"/Okada, Hisayuki/"Okada, Hisayuki ,
"/Akasaka, Takashi/"Akasaka, Takashi
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42
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3147 , 2017-11-07 , Oxford University Press (OUP)
ISSN:0195668X15229645
内容記述
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.
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