A new pooled analysis of patient-level data from Philips demonstrates the “strong safety profile” of the company’s Stellarex drug-coated balloon (DCB) in above-the-knee studies, according to a company statement. The independent, third party pooled analysis evidences low mortality rates through three years after the treatment with no device-related deaths.
Sean Lyden, chairman of the Department of Vascular Surgery, Cleveland Clinic (Cleveland, USA), presented these data at 2019 Leipzig Interventional Course (LINC; 22–25 January, Leipzig, Germany) during a symposium focusing on the long-term safety of drug-eluting technologies in the leg.
This latest data contrasts the findings of Katsanos et al’s summary-level meta-analysis published in December 2018 reporting an increased risk of death at two and five years following the use of paclitaxel-coated balloons and stents in the femoropopliteal artery. Medtronic and Cook Medical also announced data at LINC iterating the safety of their devices, the IN.PACT Admiral DCB and the Zilver PTX drug-eluting stent, respectively.
“The LINC session provided important new patient-level data regarding mortality in patients with peripheral arterial disease receiving paclitaxel devices—stents or DCBs—to restore and maintain blood flow in the superficial femoral and popliteal arteries in their legs,” says William Gray, president of the Lankenau Heart Institute (Wynnewood, USA) and investigator for the Stellarex clinical trials. “The data from the Stellarex clinical trial programmes were strong, and represented over 2,300 patients. When the three-year-outcomes were examined, there were no cardiovascular or non-cardiovascular mortality differences between the groups treated with Stellarex and the control arm. This is very reassuring, and this patient-level data will be amalgamated with other paclitaxel device data in order to complete the analysis. These efforts are already underway, as is a publication specifically regarding these Stellarex results.”
“Based on this latest patient-level analysis, we remain confident in the safety and performance of our unique Stellarex low-dose DCB,” comments Chris Barys, business leader, Image Guided Therapy Devices at Philips. “We will continue to communicate any relevant findings we obtain, to ensure our physicians have the most current information on our technologies for optimal treatment of their patients.”
The Stellarex DCB is designed to restore and maintain blood flow to arteries in patients with peripheral arterial disease and is FDA approved and CE marked in the USA and Europe.