January 28, 2020
Four-Year ILLUMENATE Data Presented for Philips Stellarex 0.035-Inch Low-Dose DCB
January 28, 2020—Royal Philips announced the 4-year results from the randomized controlled ILLUMENATE pivotal trial in the United States. The trial’s Coprimary Investigator, Sean Lyden, MD, presented the results at LINC 2020, the Leipzig Interventional Course held January 28–31 in Leipzig, Germany.
The study compared the safety and efficacy of Philips’ Stellarex 0.035-inch low-dose drug-coated balloon (DCB) to percutaneous transluminal angioplasty (PTA) treatment with uncoated balloons (the current standard of care) in restoring and maintaining blood flow in the superficial femoral artery and popliteal arteries of patients with peripheral artery disease. The study cohort had a high proportion of patients with severely calcified lesions.
According to the company, the data showed similar mortality rates through 4 years for patients treated with Stellarex DCB (15.6%) compared with those treated with PTA (15.2%). Secondary safety outcomes were also similar across the two groups. The 4-year data showed a clinically relevant lower rate of clinically driven target lesion revascularization in the Stellarex DCB patient group versus the PTA control group (28.2% vs 34.1%, respectively).
Dr. Lyden commented in the company’s press release, “The 4-year data from the ILLUMENATE pivotal trial further substantiates the 3-year results that were presented at LINC 2019 and published in Circulation in 2019. The high compliance follow-up rate further affirms the findings of these data in a complex patient population.” Dr. Lyden is Chairman of the Department of Vascular Surgery at the Cleveland Clinic in Cleveland, Ohio.
The low-dose Stellarex 0.035-inch DCB delivers < 2 µg/mL2 of paclitaxel and features the company’s EnduraCoat coating technology, which consists of a polyethylene glycol excipient with amorphous and crystalline paclitaxel particles dispersed in it. The device provides efficient drug transfer and effective drug residency coupled with high coating durability and minimal particulate loss, thereby enabling a low therapeutic drug dose, stated Royal Philips.