Published ILUMIEN II Trial Evaluates Stent Expansion Guided by OCT Versus IVUS

November 16, 2015—In the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions, Akiko Maehara, MD, et al published findings from the ILUMIEN II observational study of optical coherence tomography (OCT) in patients undergoing fractional flow reserve and percutaneous coronary intervention (2015;8:1704–1714). The study sought to determine whether OCT guidance results in a degree of stent expansion comparable to that with intravascular ultrasound (IVUS) guidance.

As summarized in JACC: Cardiovascular Interventions, the investigators compared the relative degree of stent expansion, defined as the minimal stent area divided by the mean of the proximal and distal reference lumen areas, after OCT-guided stenting in patients in the ILUMIEN I study (n = 354) and IVUS-guided stenting in patients in the ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) study (n = 586). Stent expansion was examined in all 940 patients in a covariate-adjusted analysis, as well as in 286 propensity-matched pairs (total n = 572).

In the matched-pair analysis, the degree of stent expansion was not significantly different between OCT and IVUS guidance (median [first, third quartiles], 72.8% [63.3, 81.3] vs 70.6% [62.3, 78.8], respectively; P = .29). Similarly, after adjusting for baseline differences in the entire population, there was no difference in the degree of stent expansion between the two imaging modalities (P = .84). Although a higher prevalence of post–percutaneous coronary intervention stent malapposition, tissue protrusion, and edge dissections was detected by OCT, the rates were similar after OCT- and IVUS-guided stenting.

In the present post-hoc analysis of two prospective studies, the investigators concluded that OCT and IVUS guidance resulted in a comparable degree of stent expansion and advised that randomized trials are warranted to compare the outcomes of OCT- and IVUS-guided coronary stent implantation.

In May 2015, the final results from the ILUMIEN II clinical study, as well as preliminary results from the ILUMIEN I trial, were presented as late-breaking clinical trials at the EuroPCR 2015 conference in Paris, France.