Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): Study protocol for a randomized controlled trial

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• 作者：Takashi Kubo ; MD ; PhD ; FJCC^a ; Toshiro Shinke ; MD ; PhD ; FJCC^b ; Takayuki Okamura ; MD ; PhD^c ; Kiyoshi Hibi ; MD ; PhD ; FJCC^d ; Gaku Nakazawa ; MD ; PhD^e ; Yoshihiro Morino ; MD ; PhD^f ; Junya Shite ; MD ; PhD ; FJCC^g ; Tetsuya Fusazaki ; MD ; PhD^f ; Hiromasa Otake ; MD ; PhD^b ; Ken Kozuma ; MD ; PhD^h ; Takashi Akasaka ; MD ; PhD ; FJCC^a ; ^{akasat@wakayama-med.ac.jp" class="auth_mail" title="E-mail the corresponding author}
• 关键词：Coronary artery disease ; Drug-eluting stent ; Intravascular ultrasound ; Optical coherence tomography ; Percutaneous coronary intervention
• 刊名：Journal of Cardiology
• 出版年：2016
• 出版时间：November 2016
• 年：2016
• 卷：68
• 期：5
• 页码：455-460
• 全文大小：356 K

文摘

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.

Methods and design

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.

Conclusion

When completed, the OPINION trial will contribute to define the clinical value of the OFDI guidance in PCI.