A five-year patient-level meta-analysis of the ILLUMENATE EU RCT and pivotal study results confirms the safety profile of the low-dose drug-coated Philips Stellarex .035 balloon ”
Amsterdam, Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in healthcare technology, today announced the five-year patient-level meta-analysis of two large randomized controlled trials (RCTs). The results, which represent the highest level of the pyramid of evidence , confirm the long-term safety of the Philips Stellarex Drug-Coated (DCB) balloon. The meta-analysis shows no difference in annual mortality for up to five years for patients treated with low-dose Stellarex DCB compared to those treated with percutaneous transluminal angioplasty (PTA), the current standard of care. The meta-analysis was presented to the International Charing Cross Symposium 2021.
The ILLUMENATE EU RCT and ILLUMENATE Pivotal RCT meta-analysis includes approximately 600 patients in Europe and the United States, and constitutes the largest homogeneous dataset of patients from paclitaxel DCB RCTs with a five-year follow-up. [2,3]. After five years, the meta-analysis of the two studies shows no difference in survival rate, 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 more Stellarex DCBs in a patient is not a predictor of mortality. The meta-analysis has a vital status monitoring compliance of over 90%.
“This meta-analysis confirms and strengthens the consistent and sustainable long-term safety profile of low-dose Stellarex DCB over five years,” said William Gray, MD, FACC, FSCAI, and president of the Lankenau Heart Institute, a researcher for the Stellarex clinical trials which presented the results. “The results are an important contribution to the long-term safety of paclitaxel-coated devices.”
“Stellarex is the only DCB paclitaxel to consistently demonstrate no difference in mortality each year over five years from ATP in multiple RCTs and in a patient-level meta-analysis,” said Chris Landon, senior vice president and Managing Director of Image Guided Therapy Devices at Philips. “We are committed to providing healthcare providers with accurate and transparent data to help them make an informed decision about the optimal treatment for each patient with peripheral artery disease. With its low drug dose and unique drug coating composition, Stellarex is a logical choice for those who need this option. “
Featuring Philips EnduraCoat technology, a unique coating made of a polyethylene glycol excipient containing dispersed amorphous and crystalline paclitaxel particles, the Philips Drug-Coated – Stellarex 0.035 ” balloon is unlike any other DCB for the treatment of disease peripheral arterial. EnduraCoat technology ensures efficient drug transfer and efficient drug residency, coupled with high coating durability and minimal particle loss, thereby enabling a low dose of therapeutic drug.
Philips Image Guided Therapy business provides comprehensive procedural solutions of disease-specific systems, smart devices, software and services for minimally invasive procedures, helping caregivers decide, guide, treat and confirm the correct therapy for each patient during their procedure.
 Katsanos et al. Risk of death following application of paclitaxel-coated balloons and stents to the femoro-popliteal artery of the leg: systematic review and meta-analysis of randomized controlled trials. JAHA, December 8, 2018.
 Schneider et al. Paclitaxel exposure: long-term safety and efficacy of a drug-coated balloon for lameness in pooled randomized trials. Catheterization and Cardiovascular Procedures, August 24, 2020.