title: Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): Study protocol for a randomized controlled trial.
abstract: Optical coherence tomography is becoming increasingly widespread as an adjunctive intravascular diagnostic technique in percutaneous coronary intervention (PCI), because of its ability to visualize coronary structures at high resolution. Several studies have reported that intravascular ultrasound (IVUS) guidance in PCI might be helpful to reduce subsequent stent thrombosis, restenosis, repeat revascularization, myocardial infarction, and cardiac death. The OPtical frequency domain imaging vs. INtravascular ultrasound in percutaneous coronary InterventiON (OPINION) trial is aimed at evaluating the impact of optical frequency domain imaging (OFDI) guidance in PCI on clinical outcomes compared with IVUS guidance.
  
  
  
  The OPINION trial is a multicenter, prospective, randomized, controlled, open-label, parallel group, non-inferiority trial in Japan. The eligible patients are randomly assigned to receive either OFDI-guided PCI or IVUS-guided PCI. PCI is performed using the biolimus-eluting stent in accordance with a certain criteria of OFDI and IVUS for optimal stent deployment. All patients will undergo a follow-up angiography at 8 months. The primary endpoint is target vessel failure composed of cardiac death, myocardial infarction attributed to the target vessel, and clinically-driven target vessel revascularization at 12 months.
  
  
  
  When completed, the OPINION trial will contribute to define the clinical value of the OFDI guidance in PCI.
authors.affiliation: Department of Cardiovascular Medicine, Wakayama Medical University, Wakayama, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Kubo
authors.affiliation: Department of Internal Medicine, Division of Cardiovascular and Respiratory Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.
authors.forename: Toshiro
authors.initials: T
authors.lastname: Shinke
authors.affiliation: Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine, Ube, Japan.
authors.forename: Takayuki
authors.initials: T
authors.lastname: Okamura
authors.affiliation: Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan.
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Hibi
authors.affiliation: Division of Cardiology, Tokai University School of Medicine, Isehara, Japan.
authors.forename: Gaku
authors.initials: G
authors.lastname: Nakazawa
authors.affiliation: Division of Cardiology, Iwate Medical University, Morioka, Japan.
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Morino
authors.affiliation: Division of Cardiology, Osaka Saiseikai Nakatsu Hospital, Osaka, Japan.
authors.forename: Junya
authors.initials: J
authors.lastname: Shite
authors.affiliation: Division of Cardiology, Iwate Medical University, Morioka, Japan.
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Fusazaki
authors.affiliation: Department of Internal Medicine, Division of Cardiovascular and Respiratory Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.
authors.forename: Hiromasa
authors.initials: H
authors.lastname: Otake
authors.affiliation: Division of Cardiology, Teikyo University School of Medicine, Tokyo, Japan.
authors.forename: Ken
authors.initials: K
authors.lastname: Kozuma
authors.affiliation: Department of Cardiovascular Medicine, Wakayama Medical University, Wakayama, Japan. Electronic address: akasat@wakayama-med.ac.jp.
authors.forename: Takashi
authors.initials: T
authors.lastname: Akasaka
mesh_terms: D003324:Coronary Artery Disease / Q000628:therapy; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D011446:Prospective Studies; D041623:Tomography, Optical Coherence; D018084:Ultrasonography, Interventional
keywords: Coronary artery disease; Drug-eluting stent; Intravascular ultrasound; Optical coherence tomography; Percutaneous coronary intervention