{"id":"889e4dd9f07f","type":"article","url":"https://hartvaat.nl/2017/11/07/optische-frequentiedomeinbeeldvorming-versus-ivus-bij-pci-opinion-trial/","title":"Optische frequentiedomeinbeeldvorming versus IVUS bij PCI: OPINION-trial","title_en":"Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): one-year angiographic and clinical results.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":["intracoronaire-beeldvorming"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehx351","source_url":"https://doi.org/10.1093/eurheartj/ehx351","authors":["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"],"significance":6,"published":"2017-11-07","source_date":"2017-11-07","image":"","kennis":["https://hartvaat.nl/kennis/diagnostiek/intravasculaire-echografie-ivus-oct/","https://hartvaat.nl/kennis/antistolling/dubbele-antistolling-indicaties/"],"congress":"","summary_en":"The OPINION trial compared optical frequency domain imaging (OFDI) with IVUS for guiding PCI, demonstrating that these two intravascular imaging modalities produce comparable clinical outcomes and can be used interchangeably.","created":"2026-07-03T10:27:00Z","updated":"2026-07-03T13:26:16Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"OPINION-trial die OFDI vergeleek met IVUS voor het sturen van PCI. Vergelijking van twee intracoronaire beeldvormingsmodaliteiten.","abstract_original":"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."}