June 26, 2020
ILLUMENATE EU RCT Results Evaluate Philips’ Stellarex DCB at 4 Years
June 26, 2020—Royal Philips announced 4-year results from the ILLUMENATE European Randomized Controlled Trial (EU RCT) evaluating the safety and efficacy of Philips’ Stellarex 0.035-inch low-dose drug-coated balloon (DCB) to restore and maintain patency in the superficial femoral artery and popliteal arteries of patients with peripheral artery disease (PAD).
According to the company, the Stellarex DCB cohort demonstrated similar all-cause mortality compared with the control arm through 4 years. This analysis included missing data found post hoc to achieve follow-up compliance of 93.9%, increasing the robustness of the statistical analysis. The results were evaluated in comparison to percutaneous transluminal angioplasty (PTA) treatment with uncoated balloons. The data were presented online by William Gray, MD, during the 2020 Vascular Interventional Advances (VIVA) Late-Breaking Clinical Trial live-stream.
The mortality rate at 4 years showed 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,” commented Dr. Gray, in the company's press release. Dr. Gray, an investigator for the Stellarex clinical trials, is President of the Lankenau Heart Institute in Wynnewood, Pennsylvania.
Professor Marianne Brodmann, MD, a primary investigator for the trial, added, “The results from the ILLUMENATE EU RCT trial continue to demonstrate durable long-term results at a high rate of follow-up compliance.” Prof. Brodmann is a vascular specialist at the Medical University of Graz, Austria.
The company noted that the 4-year ILLUMENATE EU RCT data validate the long-term safety profile of the Stellarex DCB, which showed similar mortality rates at 4-years in the ILLUMENATE pivotal RCT in the United States reported presented by coprimary investigator, Sean Lyden, MD, at LINC 2020, the Leipzig Interventional Course held January 28-31 in Leipzig, Germany.