ILUMIEN Data Demonstrate Clinical Benefits of St. Jude Medical's OCT Technology

May 20, 2015—St. Jude Medical, Inc. announced that preliminary results from the ILUMIEN I trial and final results from the ILUMIEN II clinical study were presented as late-breaking clinical trials at the EuroPCR 2015 conference in Paris, France. 

The studies show that with resolution up to 10 times higher than intravascular ultrasound (IVUS), optical coherence tomography (OCT) imaging can help improve stent selection and deployment, better support clinical decision-making, and improve patient outcomes, stated the company. 

According to St. Jude Medical, these findings further advance the use of OCT imaging alongside percutaneous coronary intervention (PCI). The ILUMIEN II study found that OCT guidance can yield a similar degree of stent expansion, or support full stent deployment, in comparison to IVUS.

ILUMIEN I assessed 418 patients suffering stable or unstable angina or non-ST segment elevation myocardial infarction. The study’s 12-month data shows that OCT guidance conducted either pre- or post-PCI altered physician decision-making in 65% of patients. Pre-PCI OCT altered treatment planning in 55% of patients and led to changes in decisions related to stent length and diameter. OCT imaging was associated with a reduction of in-hospital myocardial infarction when used pre- and post-PCI to change the procedural strategy.

In the company’s press release, William Wijns, MD, 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.” Dr. Wijns is Co-Director of the Cardiovascular Centre in Aalst, Belgium.

The ILUMIEN II study was designed to determine whether OCT guidance results in a comparable degree of stent expansion as IVUS imaging. After an analysis of OCT-guided stenting or IVUS-guided stenting in 940 patients from the ILUMIEN I and ADAPT-DES studies, the degree of stent expansion was found to be comparable between OCT and IVUS imaging. The study’s data shows OCT and IVUS guidance were also associated with comparable rates of major stent malapposition, tissue protrusion, and stent edge dissection, reported St. Jude Medical.

Gregg W. Stone, MD, who is Study Chairman of ILUMIEN II, commented in the company's announcement, “The results of ILUMIEN II address long-standing questions regarding the ability of OCT guidance to achieve comparable stent expansion, more precise measurements, and a greater level of vascular visualization than first-generation imaging tools such as IVUS. Now, the results of angiography-guided, IVUS-guided, and OCT-guided stent implantation are currently being evaluated in the prospective, multicenter ILUMIEN III: OPTIMIZE PCI randomized trial.” Dr. Stone is Professor of Medicine at Columbia University Medical Center in New York, New York.