5-Year Data Presented for Philips’ Stellarex DCB

January 25, 2021—Royal Philips 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 company’s Stellarex 0.035-inch, low-dose drug-coated balloon (DCB) and those treated with percutaneous transluminal angioplasty (PTA). Additionally, the studies showed no difference in mortality between the Stellarex DCB and PTA at every 12-month endpoint over the course of the studies.

The data from the ILLUMENATE European randomized controlled trial (EU RCT) and the ILLUMENATE pivotal RCT were presented at LINC 2021, the Leipzig Interventional Course being held as a virtual event January 25-29.

According to Philips, the two trials are composed of approximately 600 patients in Europe and the United States. Both studies had a high vital status follow-up compliance, with the status of > 90% of patients known.

After 5 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 5-year results for the ILLUMENATE pivotal study showed no statistically significant difference among patients treated with the Stellarex DCB (21.2%) compared to those treated with PTA (20.2%).

Marianne Brodmann, MD, professor and vascular specialist at the Medical University of Graz, Austria, served as primary investigator for both trials.

“The 5-year final results show favorable overall safety of the Stellarex low-dose paclitaxel DCB, and are applicable within an extensive patient cohort,” commented Prof. Brodmann in the company’s announcement. “Every year, the Stellarex program has demonstrated low mortality rates with no difference in rates between the two patient cohorts.”

In June 2020, the company announced that the 4-year results from the ILLUMENATE ER RCT trial were presented by William Gray, MD, during the virtual VIVA 2020, the Vascular Interventional Advances conference. Last January, Sean Lyden presented the 4-year results from the ILLUMENATE pivotal trial at LINC 2020.