OCT compared with IVUS in a coronary lesion assessment: the OPUS-CLASS study.

Objectives: The aim of this study was to investigate the reliability of frequency domain optical coherence tomography (FD-OCT) for coronary measurements compared with quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS).

Background: Accurate luminal measurement is expected in FD-OCT because this technology offers high resolution and excellent contrast between lumen and vessel wall.

Methods: In 5 medical centers, 100 patients with coronary artery disease were prospectively studied by using angiography, FD-OCT, and IVUS. In addition, 5 phantom models of known lumen dimensions (lumen diameter 3.08 mm; lumen area 7.45 mm(2)) were examined using FD-OCT and IVUS. Quantitative image analyses of the coronary arteries and phantom models were performed by an independent core laboratory.

Results: In the clinical study, the mean minimum lumen diameter measured by QCA was significantly smaller than that measured by FD-OCT (1.81 ± 0.72 mm vs. 1.91 ± 0.69 mm; p < 0.001) and the minimum lumen diameter measured by IVUS was significantly greater than that measured by FD-OCT (2.09 ± 0.60 mm vs. 1.91 ± 0.69 mm; p < 0.001). The minimum lumen area measured by IVUS was significantly greater than that by FD-OCT (3.68 ± 2.06 mm(2) vs. 3.27 ± 2.22 mm(2); p < 0.001), although a significant correlation was observed between the 2 imaging techniques (r = 0.95, p < 0.001; mean difference 0.41 mm(2)). Both FD-OCT and IVUS exhibited good interobserver reproducibility, but the root-mean-squared deviation between measurements was approximately twice as high for the IVUS measurements compared with the FD-OCT measurements (0.32 mm(2) vs. 0.16 mm(2)). In a phantom model, the mean lumen area according to FD-OCT was equal to the actual lumen area of the phantom model, with low SD; IVUS overestimated the lumen area and was less reproducible than FD-OCT (8.03 ± 0.58 mm(2) vs. 7.45 ± 0.17 mm(2); p < 0.001).

Conclusions: The results of this prospective multicenter study demonstrate that FD-OCT provides accurate and reproducible quantitative measurements of coronary dimensions in the clinical setting.