Three-Year Data Support Safety and Efficacy of the Philips Stellarex DCB

May 29, 2019—Royal Philips announced that the 3-year results from the ILLUMENATE pivotal trial and the ILLUMENATE European randomized clinical trial (EU RCT) were presented by S. Jay Mathews, MD, at the New Cardiovascular Horizons 20th annual conference held May 29–31 in New Orleans, Louisiana.

The two trials are from a series of five studies evaluating the safety and efficacy of Philips' Stellarex 0.035-inch low-dose drug-coated balloon (DCB) to restore and maintain patency in the superficial femoral artery and popliteal arteries of patients with peripheral artery disease (PAD). In the RCTs, the DCB results were evaluated compared to treatment with uncoated balloons.

According to the company, the ILLUMENATE pivotal trial results show that at 36 months, 64.2% of the patients treated with Stellarex maintained primary patency compared to 51% of the patients treated with an uncoated balloon. The ILLUMENATE EU RCT results show that at 36 months, 67.5% of the patients treated with Stellarex maintained patency compared to 59.9% of the patients treated with an uncoated balloon.

Importantly, given the current climate surrounding paclitaxel use in PAD, both studies showed no significant difference in mortality compared to treatment with uncoated balloons through 3 years.

In the ILLUMENATE pivotal trial, the mortality rate of patients treated with the Stellarex DCB compared to those treated with an uncoated balloon were 10.1% and 11%, respectively. The mortality rates were 9.4% and 8.5% for patients treated with Stellarex compared to patients treated with uncoated balloon in the EU RCT.

“The 3-year data of the ILLUMENATE pivotal trial and ILLUMENATE EU RCT add to the robust and consistent multiyear data of the Stellarex program," commented Dr. Mathews in the announcement from Royal Philips. "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 company noted that a pooled analysis of patient-level data of more that 2,300 patients treated with the Stellarex DCB in above-the-knee studies were presented by Sean Lyden, MD, at the LINC 2019, the Leipzig Interventional Course held January 22–25 in Leipzig, Germany. These data reinforce the safety profile of Stellarex, stated Philips.

The Stellarex 0.035-inch DCB has United States FDA and European CE Mark approval.