Safety, Efficacy of Philips’ Stellarex .035 Low-Dose Drug-Coated Balloon Shown in Clinical Trial

Royal Philips, a global leader in health technology, has announced 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-inch low-dose [1] 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.
 
The ILLUMENATE Pivotal trial results show that at 36 months, 64.2 percent of the patients treated with Stellarex maintained blood flow through the treated segment of the diseased artery, compared to 51 percent 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 percent also had severely calcified lesions. 
 
The ILLUMENATE EU RCT results show that at 36 months, 67.5 percent of the patients treated with Stellarex maintained blood flow (assessed through blinded core-lab adjudicated patency), compared to 59.9 percent 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 percent, compared to the mortality rate of patients treated with an uncoated balloon of 11 percent. The EU RCT showed mortality rates of 9.4 percent for patients treated with Stellarex, compared to 8.5 percent for patients treated with an uncoated balloon. 
            
“The three year data of the ILLUMENATE Pivotal trial and ILLUMENATE EU RCT add to the 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.”
 
The announcement of the three-year results from the ILLUMENATE Pivotal trial and the ILLUMENATE EU RCT follows the release in January 2019 of the most recent pooled analysis of patient-level data of over 2,300 patients treated with Philips’ Stellarex DCB in above-the-knee (ATK) studies, which reinforced the strong safety profile of Stellarex.
 
The Stellarex .035 DCB is designed to restore and maintain blood flow in diseased femoral and popliteal arteries, and is U.S. Food and Drug Administration-approved in the U.S. and CE marked in Europe. Stellarex is unlike other drug coated balloons in the industry for the treatment of peripheral artery disease as it features the EnduraCoat Technology, a coating consisting of polyethylene glycol as the base material, the so-called ‘excipient’, and a combination of amorphous and crystalline paclitaxel particles dispersed in it. EnduraCoat provides efficient drug transfer, effective drug residency with high coating durability and minimal particulate loss, and therefore enables a low therapeutic drug dose.

“We are committed to providing image-guided therapy solutions that enhance the procedure and positively impact patient outcomes,” said Bert van Meurs, chief business leader, Image Guided Therapy at Royal Philips. “Stellarex is the only low-dose drug-coated balloon with a proven treatment effect at three years compared to the existing standard-of-care in the U.S. and Europe. The combination with our interventional imaging systems, such as the Azurion platform, our recently-introduced IntraSight intravascular diagnostic application platform, and associated services, enables clinicians to decide, guide, treat and confirm the appropriate peripheral vascular treatment.”
 
[1] Low-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.
 
Royal Philips is a health technology company focused on improving people’s health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company develops diagnostic imaging technology, image-guided therapy, patient monitoring and health informatics, as well as consumer health and home care products and services. Philips generated 2018 sales of 18.1 billion euros and employs approximately 77,000 employees with sales and services in more than 100 countries.