Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the four-year results from the ILLUMENATE European Randomized Controlled Trial (EU RCT). The Stellarex DCB cohort demonstrated similar all-cause mortality compared with the control arm through four years. This analysis included missing data found post hoc to achieve a follow-up compliance of 93.9%, increasing the robustness of the statistical analysis. Along with the recently-published data on the ILLUMENATE Pivotal trial, this is the second RCT which has indicated similar mortality rates, further validating the long-term safety profile of Philips’ Stellarex low-dose Drug-Coated Balloon . The data were presented in the evening of 25 June as part of Vascular Interventional Advances’ (VIVA) first-ever late-breaking clinical trials livestream.
The four-year ILLUMENATE EU RCT data are the latest from a series of trials evaluating the safety and efficacy of the Philips Stellarex .035″ DCB in restoring and maintaining blood flow in the superficial femoral artery and popliteal arteries of patients with peripheral arterial disease. The results were evaluated compared to percutaneous transluminal angioplasty (PTA) treatment with uncoated balloons, the current standard of care. The mortality rate at four years shows no statistical difference between two patient groups, at 17.7% for the Stellarex patient group and 14.1% for the control group. Secondary safety outcomes were also similar across the two groups.
“These latest data from the ILLUMENATE EU RCT study add to the ILLUMENATE Pivotal RCT results and continue to demonstrate no statistical difference in mortality when comparing the DCB and PTA arms of the trial,” said William Gray, MD, FACC, FSCAI, and President of the Lankenau Heart Institute, an investigator for the Stellarex clinical trials who presented the results during the livestream.
“The results from the ILLUMENATE EU RCT trial continue to demonstrate durable long-term results at a high rate of follow-up compliance,” said Marianne Brodmann, MD, Professor, vascular specialist at the Medical University of Graz, Austria and a primary investigator for the trial.