Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the five-year patient-level meta-analysis of two major randomized controlled trials (RCTs). The findings, which represent the highest level of the evidence pyramid , confirm the long-term safety of the Philips Stellarex Drug-Coated Balloon (DCB). The meta-analysis shows no difference in mortality at each year through five years for patients treated with the Stellarex low-dose DCB when compared with those treated with percutaneous transluminal angioplasty (PTA), the current standard of care. The meta-analysis was presented at the 2021 Charing Cross International Symposium.
The ILLUMENATE EU RCT and ILLUMENATE Pivotal RCT meta-analysis comprises approximately 600 patients in Europe and the U.S., and is the largest homogenous patient data set of paclitaxel DCB RCTs with five-year follow-up [2,3]. After five years, the meta-analysis for the two studies shows 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 five years,” said William Gray, MD, FACC, FSCAI, and President of the Lankenau Heart Institute, an investigator for the Stellarex clinical trials who presented the results. “The results are an important contribution to the long-term safety of paclitaxel-coated devices.”