January 25, 2021
5-Year ILLUMENATE EU RCT and Pivotal Study: Philips today announced the final, 5-year results of two major randomized controlled trials (RCTs) that show no difference in all-cause mortality between patients treated with the Stellarex drug-coated balloon (DCB) and those treated with percutaneous angioplasty (PTA), the current standard of care.
Moreover, the studies showed no difference in mortality between the Stellarex DCB and PTA at every 12-month endpoint over the course of the study. Results from the two RCTs were presented at the virtual 2021 Leipzig Interventional Course (LINC).
The ILLUMENATE EU RCT and ILLUMENATE Pivotal RCT together comprised approximately 600 patients in Europe and the U.S. After five years, the ILLUMENATE EU RCT showed 19.3% mortality among patients treated with the Stellarex DCB compared to 19.4% mortality for those treated with PTA. The five-year results for the ILLUMENATE Pivotal study also show no statistically significant difference among patients treated with the Stellarex DCB (21.2%) compared to those treated with PTA (20.2%). Both studies had a high vital status follow-up compliance, with the status of over 90% of patients known.
“The five-year final results show favourable overall safety of the Stellarex low-dose paclitaxel DCB, and are applicable within an extensive patient cohort,” said Marianne Brodmann, MD, Professor, vascular specialist at the Medical University of Graz, Austria, primary investigator for both trials and a paid consultant to Philips. “Every year, the Stellarex program has demonstrated low mortality rates with no difference in rates between the two patient cohorts.”
“These study results build on the robust, consistent long-term data of the Stellarex program and confirm the safety and performance of our unique DCB,” said Chris Landon, Senior Vice President and General Manager Image Guided Therapy Devices at Philips. “The Stellarex DCB, with its low drug dose and unique drug coating composition, continues to be an important treatment choice for healthcare providers treating patients with peripheral arterial disease.”
Featuring Philips EnduraCoat technology, a unique coating consisting of a polyethylene glycol excipient with amorphous and crystalline paclitaxel particles dispersed in it, Stellarex .035” DCB is unlike any other drug-coated balloon for the treatment of peripheral artery disease. EnduraCoat technology provides efficient drug transfer and effective drug residency coupled with high coating durability and minimal particulate loss, thereby enabling a low therapeutic drug dose.
Philips’ Image Guided Therapy business provides complete procedural solutions of systems, smart devices, disease-specific software and services for minimally invasive procedures, helping caregivers decide, guide, treat and confirm the right therapy for each patient during their procedure.