November 7, 2020
Patient-Level Meta-Analysis Confirms Safety Profile of Philips Stellarex DCB at 4 Years
November 7, 2020—Royal Philips announced the results of a patient-level meta-analysis confirming the safety profile of the company’s Stellarex 0.035-inch low-dose drug-coated balloon (DCB) at 4 years.
The results show no difference in mortality between patients treated with the Stellarex DCB and those treated with percutaneous angioplasty (PTA). The meta-analysis also included data from two randomized clinical trials: the ILLUMENATE pivotal trial and the ILLUMENATE EU trial composed of 589 patients in the United States and Europe with follow-up to 4 years with high compliance on vital status data.
Sean Lyden, MD, presented the meta-analysis in a late-breaking clinical trial session at VIVA 2020, the Vascular InterVentional Advances annual meeting held as a virtual congress November 6-8, 2020. Dr. Lyden is coprimary investigator for the ILLUMENATE pivotal trial.
According to Philips, the meta-analysis found no significant difference in survival among patients treated with the Stellarex DCB compared to those treated with PTA (85.7% vs 85.6%) over 4 years. In addition, the results of the meta-analysis also show no difference in cardiovascular mortality (3.6% vs 4%) and noncardiovascular mortality (10.8% vs 10.9%).
“The meta-analysis reinforces previously presented results from the ILLUMENATE RCTs, demonstrating low mortality rates each year through 4 years, with no difference in rates between the two patient cohorts,” commented Dr. Lyden in the company’s announcement. “This independent, patient-level meta-analysis continues to provide consistent, long-term data for a large group of patients.”