Philips Stellarex DCB’s Safety Profile at 5 Years Confirmed by Meta-Analysis

April 20, 2021—Royal Philips announced that findings from a 5-year patient-level meta-analysis of two major randomized controlled trials (RCTs) of the Stellarex low-dose paclitaxel drug-coated balloon (DCB) were presented by William Gray, MD, at the 2021 Charing Cross International Symposium, which was held virtually.

According to the company, the meta-analysis showed no difference in mortality at each year through 5 years for patients treated with the Stellarex DCB compared with those treated with percutaneous transluminal angioplasty (PTA). The company noted that the findings represent the highest level of the evidence pyramid and confirm the long-term safety of the Stellarex device.

Philips stated that the meta-analysis encompassed the ILLUMENATE EU RCT and ILLUMENATE Pivotal RCT composed of a total of 600 patients in Europe and the United States. After 5 years, the meta-analysis for the two studies showed no difference in survival rates, with 80.4% for the Stellarex DCB arm and 80.4% for the PTA arm. The analysis also demonstrates that the use of one or multiple Stellarex DCBs in a patient is not a predictor of mortality. The meta-analysis has a vital status follow-up compliance of over 90%.

“This meta-analysis confirms and reinforces the consistent and durable long-term safety profile of the low-dose Stellarex DCB through 5 years,” commented Dr. Gray in Philips’ press release. “The results are an important contribution to the long-term safety of paclitaxel-coated devices.” Dr. Gray is President of the Lankenau Heart Institute in Wynnewood, Pennsylvania.