Amsterdam, the Netherlands and New Orleans, U.S. – Royal Philips (NYSE: PHG; AEX: PHIA), a global leader in health technology, today announced the three-year results from the ILLUMENATE Pivotal trial and the ILLUMENATE European randomized clinical trial (EU RCT).
These two trials are part of a series of five trials evaluating the safety and efficacy of Stellarex .035″ low-dose  DCB to restore and maintain blood flow in the superficial femoral artery and popliteal arteries of patients with peripheral arterial disease. The results were evaluated compared to treatment with uncoated balloons, the current standard of care.
S. Jay Mathews, M.D., of Bradenton Cardiology Center in Bradenton, Florida, U.S., presented the data today as a late-breaking trial at the New Cardiovascular Horizons (NCVH19) Annual Conference, and highlighted the following results:
- The ILLUMENATE Pivotal trial results show that at 36 months, 64.2% of the patients treated with Stellarex maintained blood flow through the treated segment of the diseased artery, compared to 51.0% of the patients treated with an uncoated balloon, demonstrating continued durability of the procedure.
- The ILLUMENATE Pivotal patient pool was the most complex studied in a randomized clinical trial. The pool included patients with the highest rates of comorbidities, such as diabetes and renal insufficiency, while 43.9% also had severely calcified lesions.
- The ILLUMENATE EU RCT results show that at 36 months, 67.5% of the patients treated with Stellarex maintained blood flow (assessed through blinded core-lab adjudicated patency), compared to 59.9% of the patients treated with an uncoated balloon.
- Through three years, both studies showed no significant difference in mortality compared to treatment with uncoated balloons. The mortality rate of patients treated with Stellarex in the ILLUMENATE Pivotal trial was 10.1%, compared to the mortality rate of patients treated with an uncoated balloon of 11.0%. The EU RCT showed mortality rates of 9.4% for patients treated with Stellarex, compared to 8.5%for patients treated with an uncoated balloon.
“The three year data of the ILLUMENATE Pivotal trial and ILLUMENATE EU RCT add to the robust and consistent multi-year data of the Stellarex program,” said S. Jay Mathews, M.D. “The demonstrated durability of Stellarex in the complex patient pool of the ILLUMENATE Pivotal trial, which are patients that are at high risk for restenosis, a recurring blockage, is unique in the industry. Moreover, we continue to see no significant difference in mortality rates between patients treated with Stellarex and those treated with uncoated balloons, which confirms our confidence in the safety profile of Stellarex.”