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

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

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.

© The Author 2017. Published by Oxford University Press on behalf of the European Society of Cardiology

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).

References

    1. Mintz GS, Weissman NJ.. Intravascular ultrasound in the drug-eluting stent era. J Am Coll Cardiol 2006;48:421–429.
    1. Hong SJ, Kim BK, Shin DH, Nam CM, Kim JS, Ko YG, Choi D, Kang TS, Kang WC, Her AY, Kim YH, Hur SH, Hong BK, Kwon H, Jang Y, Hong MK.. Effect of intravascular ultrasound-guided vs angiography-guided everolimus-eluting stent implantation: the IVUS-XPL randomized clinical trial. Jama 2015;314:2155–2163.
    1. Galassi AR, Sumitsuji S, Boukhris M, Brilakis ES, Di Mario C, Garbo R, Spratt JC, Christiansen EH, Gagnor A, Avran A, Sianos G, Werner GS.. Utility of intravascular ultrasound in percutaneous revascularization of chronic total occlusions: an overview. JACC Cardiovasc Interv 2016;9:1979–1991.
    1. Zhang Y, Farooq V, Garcia-Garcia HM, Bourantas CV, Tian N, Dong S, Li M, Yang S, Serruys PW, Chen SL.. Comparison of intravascular ultrasound versus angiography-guided drug-eluting stent implantation: a meta-analysis of one randomised trial and ten observational studies involving 19,619 patients. EuroIntervention 2012;8:855–865.
    1. Prati F, Guagliumi G, Mintz GS, Costa M, Regar E, Akasaka T, Barlis P, Tearney GJ, Jang IK, Arbustini E, Bezerra HG, Ozaki Y, Bruining N, Dudek D, Radu M, Erglis A, Motreff P, Alfonso F, Toutouzas K, Gonzalo N, Tamburino C, Adriaenssens T, Pinto F, Serruys PW, Di Mario C.. Expert review document part 2: methodology, terminology and clinical applications of optical coherence tomography for the assessment of interventional procedures. Eur Heart J 2012;33:2513–2520.
    1. Wijns W, Shite J, Jones MR, Lee SW, Price MJ, Fabbiocchi F, Barbato E, Akasaka T, Bezerra H, Holmes D.. Optical coherence tomography imaging during percutaneous coronary intervention impacts physician decision-making: ILUMIEN I study. Eur Heart J 2015;36:3346–3355.
    1. Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Jüni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A.. 2014 ESC/EACTS Guidelines on myocardial revascularization: the Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J 2014;35:2541–2619.
    1. Kubo T, Shinke T, Okamura T, Hibi K, Nakazawa G, Morino Y, Shite J, Fusazaki T, Otake H, Kozuma K, Akasaka T.. Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): study protocol for a randomized controlled trial. J Cardiol 2016;68:455–460.
    1. Ino Y, Kubo T, Matsuo Y, Yamaguchi T, Shiono Y, Shimamura K, Katayama Y, Nakamura T, Aoki H, Taruya A, Nishiguchi T, Satogami K, Yamano T, Kameyama T, Orii M, Ota S, Kuroi A, Kitabata H, Tanaka A, Hozumi T, Akasaka T.. Optical coherence tomography predictors for edge restenosis after everolimus-eluting stent implantation. Circ Cardiovasc Interv 2016;9:pii:e004231.
    1. Kubo T, Akasaka T, Shite J, Suzuki T, Uemura S, Yu B, Kozuma K, Kitabata H, Shinke T, Habara M, Saito Y, Hou J, Suzuki N, Zhang S.. OCT compared with IVUS in a coronary lesion assessment: the OPUS-CLASS study. JACC Cardiovasc Imaging 2013;6:1095–1104.
    1. Kim IC, Yoon HJ, Shin ES, Kim MS, Park J, Cho YK, Park HS, Kim H, Nam CW, Han SW, Kim YN, Kim KB, Hur SH.. Usefulness of frequency domain optical coherence tomography compared with intravascular ultrasound as a guidance for percutaneous coronary intervention. J Interv Cardiol 2016;29:216–224.
    1. Habara M, Nasu K, Terashima M, Kaneda H, Yokota D, Ko E, Ito T, Kurita T, Tanaka N, Kimura M, Ito T, Kinoshita Y, Tsuchikane E, Asakura K, Asakura Y, Katoh O, Suzuki T.. Impact of frequency-domain optical coherence tomography guidance for optimal coronary stent implantation in comparison with intravascular ultrasound guidance. Circ Cardiovasc Interv 2012;5:193–201.
    1. Ali ZA, Maehara A, Généreux P, Shlofmitz RA, Fabbiocchi F, Nazif TM, Guagliumi G, Meraj PM, Alfonso F, Samady H, Akasaka T, Carlson EB, Leesar MA, Matsumura M, Ozan MO, Mintz GS, Ben-Yehuda O, Stone GW.. Optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation (ILUMIEN III: OPTIMIZE PCI): a randomised controlled trial. Lancet 2016;388:2618–2628.
    1. Prati F, Di Vito L, Biondi-Zoccai G, Occhipinti M, La Manna A, Tamburino C, Burzotta F, Trani C, Porto I, Ramazzotti V, Imola F, Manzoli A, Materia L, Cremonesi A, Albertucci M.. Angiography alone versus angiography plus optical coherence tomography to guide decision-making during percutaneous coronary intervention: the Centro per la Lotta contro l'Infarto-Optimisation of Percutaneous Coronary Intervention (CLI-OPCI) study. EuroIntervention 2012;8:823–829.

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