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Randomized Controlled Trial
. 2017 Nov 7;38(42):3139-3147.
doi: 10.1093/eurheartj/ehx351.

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

Takashi Kubo  1 , Toshiro Shinke  2 , Takayuki Okamura  3 , Kiyoshi Hibi  4 , Gaku Nakazawa  5 , Yoshihiro Morino  6 , Junya Shite  7 , Tetsuya Fusazaki  6 , Hiromasa Otake  2 , Ken Kozuma  8 , Tetsuya Ioji  9 , Hideaki Kaneda  9 , Takeshi Serikawa  10 , Toru Kataoka  11 , Hisayuki Okada  12 , Takashi Akasaka  1 ; OPINION Investigators
Affiliations
Randomized Controlled Trial

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

Takashi Kubo et al. Eur Heart J. .

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.

Keywords: Drug-eluting stent; Intravascular ultrasound; Optical coherence tomography; Percutaneous coronary intervention.

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Figures

Figure 1
Figure 1
Trial profile.
Summarizing figure
Summarizing figure
Non-inferiority test for the target vessel failure (primary endpoint) based on hazard ratio (A) and target vessel failure-free survival curves through 12-month follow-up (B).
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