Reproducibility of quantitative optical coherence tomography for stent analysis

Area of Science:

• Cardiovascular imaging
• Medical device analysis
• Interventional cardiology

Background:

• Accurate assessment of drug-eluting stents (DES) is crucial for long-term clinical outcomes.
• Optical coherence tomography (OCT) is a key imaging modality for evaluating stent deployment and tissue response.
• Standardized and reproducible measurements are essential for reliable DES assessment.

Purpose of the Study:

• To evaluate the inter- and intra-observer reproducibility of strut count, strut apposition, and strut tissue coverage measurements using OCT.
• To determine the reliability of OCT measurements in a core laboratory setting.

Main Methods:

• Ten drug-eluting stents were analyzed using OCT nine months post-implantation.
• Two independent analysts performed measurements, with one repeating the analysis for reproducibility assessment.
• Measurements included strut count, lumen and stent area, tissue coverage, and malapposed struts using proprietary software.

Main Results:

• Excellent agreement was observed for strut number count (inter-observer Kendall's Tau-b 0.90, intra-observer 0.94).
• Relative differences for lumen area, stent area, and tissue coverage were approximately 1%.
• Complete agreement (Kappa=1) was achieved for malapposed strut classification.

Conclusions:

• OCT demonstrates excellent inter- and intra-observer reproducibility for key measurements of drug-eluting stents.
• These findings highlight the value of OCT for the clinical long-term assessment of stents.
• OCT is a reliable tool for quantitative analysis in interventional cardiology studies.