OPINION Study Shows Good Clinical Outcomes with Optical Frequency Domain Imaging in PCI

May 31, 2016—The use of optimal frequency domain imaging (OFDI) to guide percutaneous coronary intervention (PCI) with second-generation drug-eluting stents (DES) has been shown to achieve equivalent clinical and angiographic outcomes to intravascular ultrasound- (IVUS-) guided PCI at 12 months. These findings were from the OPINION study and were presented at the EuroPCR 2016 conference held May 17–20 in Paris, France.

In the EuroPCR announcement, Study Investigator Takaski Kubo, MD, commented, “OPINION is the first study to compare clinical outcomes with OFDI and IVUS to assess lesion morphology during PCI with second-generation DES.” Dr. Kubo is from Wakayama University in Wakayama, Japan.

As summarized in the EuroPCR press release, the OPINION study investigators randomized 800 patients (mean, 68 years) scheduled for PCI using DES to either OFDI-guided PCI or IVUS-guided PCI at 42 centers in Japan. Patients underwent PCI using DES with resorbable polymer in de novo native coronary artery lesions. The patients were followed-up with angiography at 8 months and the primary endpoint was target vessel failure assessment during clinical follow-up at 12 months. Results of the noninferiority study, reported at EuroPCR 2016, showed a similarly low rate of target vessel revascularization, a composite of cardiac death, target vessel-related myocardial infarction, and clinically driven target vessel revascularization at 12 months in patients undergoing OFDI-guided PCI (5.2%) versus patients randomized to IVUS-guided PCI (4.9%).

Dr. Kubo reported, “The clinical outcome in both OCT-guided PCI and IVUS-guided PCI was excellent.” Suggesting that the study results contribute to defining the clinical value of OCT guidance in PCI, he added, “Our results might influence the next European Society of Cardiology guidelines, which currently give a class IIb recommendation for OCT. OCT use during PCI should have a class IIa recommendation.”

Commenting on the findings in the EuroPCR announcement, Takashi Akasaka, MD, stated, “There has previously been no direct comparative data for OCT/OFDI-guided PCI and IVUS-guided PCI. The OPINION study succeeded in demonstrating that OCT-guided PCI resulted in equivalent clinical and angiographic outcomes at 12 months to IVUS-guided PCI.” 

Prof. Akasaka, who is from Wakayama Medical University in Wakayama, Japan, considers the clinical outcome of both imaging strategies as very good, with a low rate of target vessel revascularization. He added, “Thus, the OPINION study may contribute to define the clinical value of the OCT guidance in PCI.” Additionally, he agrees that the findings mean that OCT/OFDI-guided PCI should be given a class IIa recommendation.