With mortality rates similar to standard of care through four years with excellent rate of follow-up compliance, Philips Stellarex is the only low-dose drug-coated balloon (DCB) to demonstrate sustained treatment effect and high safety profile through four years.
(Leipzig, Germany) January 28, 2020 -- Royal Philips today announced the four-year results from the randomized controlled ILLUMENATE Pivotal trial in the U.S. With an excellent follow-up compliance rate of over 95% in a highly complex disease patient cohort, the data show similar mortality rates through four years for patients treated with Stellarex compared to those treated with the current standard of care (plain balloon angioplasty). The results were presented at the Leipzig Interventional Course today, January 28th, by Sean Lyden, MD, Chairman of the Department of Vascular Surgery, Cleveland Clinic (U.S.), and co-Primary Investigator for the ILLUMENATE Pivotal trial.1
The four-year ILLUMENATE Pivotal trial data are the latest data from a series of trials evaluating the safety and efficacy of the Stellarex .035-inch low-dose2 DCB in restoring and maintaining blood flow in the superficial femoral artery and popliteal arteries of patients with peripheral arterial disease. The results were evaluated compared to percutaneous transluminal angioplasty (PTA) treatment with uncoated balloons, the current standard of care.
“The four-year data from the ILLUMENATE Pivotal trial further substantiates the three-year results that were presented at LINC 2019 and published in Circulation in 2019,” said Sean Lyden, MD. “The high compliance follow-up rate further affirms the findings of these data in a complex patient population.”
The study’s patient population is complex with a high proportion suffering from severely calcified lesions. The mortality rate at four years was virtually identical between the two patient groups, at 15.6% for the Stellarex patient group and 15.2% for the control group. Secondary safety outcomes were also similar across the two groups. The four-year data also show a clinically relevant lower rate of clinically-driven target lesion revascularization (CD-TLR) in the Stellarex DCB patient group of 28.2%, vs 34.1% in the control group. CD-TLR is a commonly used indicator of treatment efficacy durability.
Featuring Philips EnduraCoat technology, a unique coating consisting of a polyethylene glycol excipient with amorphous and crystalline paclitaxel particles dispersed in it, the Stellarex .035-inch DCB is unlike any other drug-coated balloon 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.
1As the study sponsor, Philips was involved in the study design and data collection but was not involved in the analysis or interpretation of the data. Sean Lyden has a consulting relationship with Philips but has not received financial compensation from Philips with regard to the Pivotal data analysis and presentation.
2Low-dose DCBs are those that deliver a dose of only 2 micrograms of the drug paclitaxel per square millimeter, which is lower than some other DCBs on the market.