Reproducibility of serial optical coherence tomography measurements for lumen area and plaque components in humans (The CLI-VAR [Centro per la Lotta Contro l'Infarto-variability] II study).

Frequency-domain optical coherence tomography (FD-OCT) is a promising intracoronary imaging technique to study atherosclerosis. Indeed, its unprecedented spatial resolution allows the assessment of fibrous cap thickness, lipid pool and features of plaque vulnerability. Aim of this study was to determine the reproducibility of the in vivo FD-OCT measurements of lumen area and plaque components in serial studies. Twenty-six patients undergoing FD-OCT assessment of intermediate lesion during coronary angiography were included in this study. FD-OCT pullbacks were acquired twice from the same coronary segment at interval of 5 min without additional intervention and analyzed off-line at an independent imaging core laboratory. Lumen diameter (LD), lumen area (LA), fibrous cap (FC) thickness and lipid pool (LP) arc extension measurements were compared in 440 matched frames. Both the per-segment and per-frame analyses showed excellent correlation coefficients for the inter-pullback comparisons for all parameters explored (R > 0.95 and p < 0.001 in all cases). Accordingly, the Bland-Altman estimates of bias showed non-significant differences in the inter-pullback comparisons at all levels. Per-frame analysis showed a slightly variations of LA in 45.8% of cases with changes greater than 2% likely related to different phases of cardiac cycle. Nevertheless, nor FC thickness or circumferential arc of LP were affected by LA changes during serial FD-OCT acquisition. This study showed an excellent reproducibility of lumen and plaque component measurements obtained with FD-OCT in vivo. Thus, this intracoronary imaging technique could be used to assess atherosclerosis progression and describe accurate plaque evolution in repeated serial studies.