OPtical frequency domain imaging vs. INtravascular ultrasound in percutaneous coronary InterventiON in patients with Acute Coronary Syndrome: Study protocol for a randomized controlled trial.
BACKGROUND
A recent clinical trial demonstrated that optical frequency domain imaging (OFDI) guidance in percutaneous coronary intervention (PCI) is noninferior to intravascular ultrasound (IVUS) guidance in patients with coronary artery disease with regard to target vessel failure (composed of cardiac death, myocardial infarction attributed to the target vessel, and clinically-driven target vessel revascularization) at 12 months. The impact of OFDI guidance in PCI for patients with acute coronary syndrome (ACS) remains uncertain.


METHODS
OPINION ACS is a multicenter, prospective, randomized, controlled, open-label, parallel group, non-inferiority trial in Japan. Eligible patients will be randomly assigned to receive either OFDI- or IVUS-guided PCI. PCI is performed using the sirolimus-eluting stent in accordance with certain OFDI and IVUS criteria for optimal stent deployment. All patients will undergo follow-up angiography and OFDI imaging at 8 months. The primary endpoint is the minimum lumen area, as measured by OFDI at 8 months.


CONCLUSION
The OPINION ACS trial outcomes will provide insights regarding the impact of OFDI-guided PCI on in-stent restenosis at 8 months in patients with ACS.
['Otake|Hiromasa|H|', 'Kubo|Takashi|T|', 'Shinke|Toshiro|T|', 'Hibi|Kiyoshi|K|', 'Tanaka|Shigemitsu|S|', 'Ishida|Masaru|M|', 'Kataoka|Toru|T|', 'Takaya|Tomofumi|T|', 'Iwasaki|Masamichi|M|', 'Sonoda|Shinjo|S|', 'Ioji|Tetsuya|T|', 'Akasaka|Takashi|T|']
D054058:Acute Coronary Syndrome D000368:Aged D054855:Drug-Eluting Stents D000074099:Equivalence Trials as Topic D005260:Female D006801:Humans D007564:Japan D008297:Male D008875:Middle Aged D062645:Percutaneous Coronary Intervention D011446:Prospective Studies D016032:Randomized Controlled Trials as Topic D020123:Sirolimus D025321:Surgery, Computer-Assisted D041623:Tomography, Optical Coherence D016896:Treatment Outcome D018084:Ultrasonography, Interventional
Optical frequency domain imaging Intravascular ultrasound Optical coherence tomography