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

Stellarex is the only Drug-Coated Balloon (DCB) to consistently demonstrate no difference in mortality every year through five years when compared with percutaneous transluminal angioplasty (PTA), the current standard of care.

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 [1], 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.”

“Stellarex is the only paclitaxel DCB to consistently demonstrate no difference in mortality every year through five years compared to PTA in multiple RCTs and in a patient-level meta-analysis,” said Chris Landon, Senior Vice President and General Manager 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 on the optimal treatment for each patient with peripheral arterial disease. With its low drug dose and unique drug coating composition, Stellarex is a logical choice for those who require this option.”

Featuring Philips EnduraCoat technology, a unique coating consisting of a polyethylene glycol excipient with amorphous and crystalline paclitaxel particles dispersed in it, Philips Drug-Coated Balloon – Stellarex .035” is unlike any other DCB for the treatment of peripheral artery disease. EnduraCoat technology provides efficient drug transfer and effective drug residency coupled with high coating durability and minimal particulate loss, thereby enabling a low therapeutic drug dose.

Philips’ Image Guided Therapy business provides complete procedural solutions of systems, smart devices, disease-specific software and services for minimally invasive procedures, helping caregivers decide, guide, treat and confirm the right therapy for each patient during their procedure. 

[1] https://www.cebm.ox.ac.uk/resources/levels-of-evidence/ocebm-levels-of-evidence.
[2] Katsanos et al. Risk of Death Following Application of Paclitaxel‐Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta‐Analysis of Randomized Controlled Trials. JAHA, December 8, 2018.
[3] Schneider et al. Paclitaxel exposure: Long-term safety and effectiveness of a drug-coated balloon for claudication in pooled randomized trials. Catheterization & Cardiovascular Interventions, August 24, 2020.