Analysis of reproducibility of reference lumen quantitation with intravascular ultrasound in stented coronary arteries.

Intravascular ultrasound is widely used to guide coronary stent implantation. The key quantitative criterion for successful implantation is the demonstration of adequate expansion of the stented lumen relative to that of the adjacent reference vessel segments. In this study we aimed to establish the reproducibility of intravascular ultrasound measurements of the reference segments in lesions undergoing coronary stenting. Measurements of the reference segment lumen dimensions warn made in a blinded fashion by two experienced observers, and reproducibility was assessed by calculating the mean difference and standard deviation of the paired measurements. The unselected intraobserver random variability of the mean reference lumen area measured 0.6 mm2. The interobserver random variability was 0.94 mm2. The intraobserver and interobserver variability of minimum lumen area within the stent was smaller, measuring 0.30 mm2 and 0.52 mm2, respectively. There was 91% intraobserver agreement, and 75% interobserver agreement, in identifying adequate stent expansion as defined by a stent-to-mean reference lumen area ratio of > 0.8. The potentially significant level of variability inherent in selecting and measuring the reference segments, and its impact on clinical decision-making, should be remembered when this method of assessing the acute quantitative outcome of stent implantation is applied.