Third-party evaluation confirms safety profile of Philips Stellarex .035′′ low-dose drug-coated balloon

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Primary safety analysis of Stellarex drug-coated balloon (DCB) three-year data, comprising the largest published, pooled set of randomized controlled trial (RCT) data for a single paclitaxel-based device, shows no difference in mortality between patients treated with the #philips Stellarex DCB and those treated with percutaneous angioplasty, the current standard of care

Findings also identified no device-related deaths and no correlation of Stellarex DCB to late all-cause mortality

The analyses represent one of industry’s most extensive and rigorous safety assessments of a paclitaxel-based device, and were published in Circulation, a peer-reviewed journal of the American Heart Association

Amsterdam, the Netherlands – Royal #philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the results of third-party analyses of patient-level data from worldwide clinical trials of the #philips Stellarex .035′′ low-dose DCB. The analyses, which were performed by US-based contract research organization Syntactx, were published today in Circulation, a peer-reviewed journal of the American Heart Association.

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. 419 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% of patients in the Pivotal study and 3.7% 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 #seanlyden, MD 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.”

We are confident in the finding of no difference in mortality rates between patients treated with Stellarex and those treated with PTA.

William Gray

MD, FACC, FSCAI, President of the Lankenau Heart Institute.