The safety analyses applied validated statistical tests commonly accepted for large-scale meta-analyses. The primary analysis examined the three-year patient-level data from the ILLUMENATE Pivotal trial and the ILLUMENATE European Randomized Controlled Trial (EU RCT), which together included a total of 589 patients. Four hundred nineteen were treated with Stellarex DCB to restore and maintain blood flow to arteries in the legs (above the knee), and 170 patients were treated with an uncoated percutaneous angioplasty (PTA) balloon, the current standard of care. Only 2.3 percent of patients in the Pivotal study and 3.7 percent of patients in the EU RCT were lost to follow-up within the respective three-year follow-up windows. The additional analysis comprised the two Stellarex DCB RCTs in addition to the four Stellarex DCB single-arm studies in the meta-analysis, including 2,495 patients with peripheral artery disease, of which 2,325 were treated with Stellarex DCB to restore and maintain blood flow to arteries in the legs (above the knee).
The primary safety analysis demonstrated that there is no difference in mortality between patients treated with Stellarex DCB and uncoated PTA through three years. It also identified no device-related deaths and no correlation of Stellarex DCB to late all-cause mortality. These findings were confirmed and reinforced by the additional analysis.
“This manuscript further substantiates the results presented earlier this year at the 2019 Leipzig Interventional Course (LINC) in Leipzig, Germany,” said Sean Lyden, M.D., and chairman of the Department of Vascular Surgery, Cleveland Clinic (U.S.), co-primary investigator for the ILLUMENATE Pivotal trial, and senior author of the safety manuscript. “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 an assessment of the patient-level outcomes related to the Stellarex drug-coated balloon,” said William Gray, M.D., FACC, FSCAI, president of the Lankenau Heart Institute, and lead author of the safety manuscript. “We are confident in the finding of no difference in mortality rates between patients treated with Stellarex and those treated with PTA.”
As the study sponsor, Philips was involved in study design and data collection, but was not involved in the analysis or interpretation of data. Sean Lyden and William Gray have consulting relationships with Philips, but have not received financial compensation from Philips in connection with their role in this analysis.
“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 Chris Landon, general manager, Image Guided Therapy Devices, at Philips. “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.”
Featuring Philips EnduraCoat technology, a coating consisting of a polyethylene glycol excipient with amorphous and crystalline paclitaxel particles dispersed in it, Stellarex .035-inch DCB is unlike any other drug-coated balloon for the treatment of peripheral artery disease. EnduraCoat technology provides efficient drug transfer and effective drug residency coupled with high coating durability and minimal particulate loss, thereby enabling a low therapeutic drug dose.
Stellarex is the only low-dose DCB to demonstrate a significant treatment effect and high safety profile through three years. The ILLUMENATE Pivotal trial showed durable primary patency (maintained blood flow) in the most complex patient pool ever studied in a DCB randomized clinical trial.
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