Royal Philips (NYSE:PHG) said today that third-party data from worldwide clinical trials for the Stellarex drug-coated balloon showed that there was no difference in mortality between patients treated with the device compared to uncoated percutaneous transluminal angioplasty.
The primary analysis consisted of three-year patient-level data from the Illumenate pivotal trial and the Illumenate European randomized controlled trial. Altogether, the trials included 589 patients; 419 of them were treated with Stellarex to attempt to restore and maintain blood flow to arteries in the legs. The other 170 patients were treated with a standard uncoated PTA balloon, according to the analyses that were published in the American Heart Association journal Circulation.
Results showed that 2.3% of patients in the pivotal study and 3.7% in the EU RCT were lost to follow-up within the three years of the study. Additional analysis included four Stellarex single-arm studies, which included 2,495 patients with peripheral artery disease, of which 2,325 were treated with Stellarex.
The primary safety analysis showed no difference in mortality between Stellarex patients and patients treated with the standard uncoated PTA, while it also highlighted zero device-related deaths and no correlation of Stellarex to late all-case mortality.
Philips said paclitaxel-coated Stellarex is the only low-dose DCB to demonstrate a significant treatment effect and high safety profile over a three-year window. The Amsterdam-based company added that the Illumenate trial showed durable primary patency in the most complex patient pool ever studied in a DCB randomized clinical trial.
“This manuscript further substantiates the results presented earlier this year at the 2019 Leipzig Interventional Course (LINC) in Leipzig, Germany,” Cleveland Clinic chairman of vascular surgery Dr. Sean Lyden, a primary investigator on the Illumenate trials, said in prepared remarks. “The systematic analysis included a robust statistical method to ensure we could pool the individual patient data from the trials in order to enhance the accuracy of the results.”
“After a careful, detailed and appropriately directed analysis of the controlled data available from the Stellarex suite of studies, we have a robust assessment of the patient-level outcomes related to the Stellarex drug-coated balloon,” added Lankenau Heart Institute president Dr. William Gray. “We are confident in the finding of no difference in mortality rates between patients treated with Stellarex and those treated with PTA.”
“The results of this study, combined with the recently presented three-year efficacy data, confirm our confidence in the safety and performance of our unique Stellarex low-dose drug-coated balloon,” said Philips general manager of image-guided therapy devices Chris Landon. “We are committed to providing healthcare providers with accurate and transparent data in order to help them make an informed decision on the optimal treatment for patients with peripheral arterial disease. We believe Stellarex, with its low drug dose and unique drug coating composition, is a logical choice for those who need this option.”
The Stellarex DCB won FDA pre-market approval in June 2017. Shares of PHG were down -2.5% at $44.99 per share in mid-afternoon trading today.