Five-year patient-level meta-analysis of ILLUMENATE EU RCT and pivotal study results confirms safety profile of Philips Stellarex .035” low-dose Drug-Coated Balloon.

Royal Philips 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 . 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%.