St. Jude Medical's ILUMIEN I Study of OCT Imaging Published

August 17, 2015—Findings from the ILUMIEN I study have been published by William Wijns, MD, et al online ahead of print in the European Heart Journal. The investigators stated that ILUMIEN I is the largest prospective, nonrandomized, observational study of percutaneous coronary intervention (PCI) procedural practice in patients undergoing intraprocedural pre- and post-PCI fractional flow reserve (FFR) and optical coherence tomography (OCT). 

Reporting on the impact of OCT on physician decision making and the association with post-PCI FFR values and early clinical events, the ILUMIEN investigators concluded that physician decision making was affected by OCT imaging before PCI in 57% of cases and after PCI in 27% of all cases.

As summarized in the European Heart Journal, the investigators performed OCT and documentary FFR pre- and post-PCI in 418 patients (467 stenoses) with stable or unstable angina or NSTEMI. Based on pre-PCI OCT, the procedure was altered in 55% of patients (57% of all stenoses) by selecting different stent lengths (shorter in 25%, longer in 43%). After clinically satisfactory stent implantation using angiographic guidance, post-PCI FFR and OCT were repeated. 

OCT abnormalities deemed unsatisfactory by the implanting physician were identified: 14.5% malapposition, 7.6% underexpansion, and 2.7% edge dissection. This prompted further stent optimization based on OCT in 25% of patients (27% of all stenoses) using additional in-stent postdilatation (81%, 101/124) or placement of 20 new stents (12%). Optimization subgroups were identified post hoc: stent placement without reaction to OCT findings (n = 137), change in PCI planning by pre-PCI OCT (n = 165), post-PCI optimization based on post-PCI OCT (n = 41), change in PCI planning, and post-PCI optimization based on OCT (n = 65). Post-PCI FFR values were significantly different between optimization groups (lower in cases with pre- and post-PCI reaction to OCT) but were no longer different after post-PCI stent optimization. Major adverse cardiac events at 30 days were low (death = 0.25%, myocardial infarction = 7.7%, repeat PCI = 1.7%, and stent thrombosis = 0.25%), reported the investigators in the European Heart Journal.

On May 20, the study’s sponsor, St. Jude Medical, Inc., announced that the preliminary ILUMIEN I results were presented as a late-breaking clinical trial at the EuroPCR 2015 conference in Paris, France. In the company’s press release, Dr. Wijns commented, “Many physicians have long suspected that OCT’s higher resolution could support treatment planning and PCI procedural technique, and the ILUMIEN I study is another important step toward confirming OCT can contribute to the perfection of PCI."