Philips today announced four-year results from the randomised controlled ILLUMENATE pivotal trial in the USA. The data show similar mortality rates through four years for patients treated with Stellarex compared to those treated with percutaneous transluminal angioplasty (PTA). The results were presented at the Leipzig Interventional Course (LINC; 28–31 January, Leipzig, Germany) by Sean Lyden (Cleveland Clinic Ohio, USA), the co-primary investigator for the ILLUMENATE trial.
The four-year ILLUMENATE pivotal trial data are the latest data from a series of trials evaluating the safety and efficacy of the Philips Stellarex 0.035″ low-dose drug-coated balloon (DCB) in restoring and maintaining blood flow in the superficial femoral artery and popliteal arteries of patients with peripheral arterial disease (PAD). The results were evaluated compared to PTA treatment with uncoated balloons, the current standard of care.
“The four-year data from the ILLUMENATE pivotal trial further substantiates the three-year results that were presented at LINC 2019 and published in Circulation in 2019,” said Sean Lyden. “The high compliance follow-up rate further affirms the findings of these data in a complex patient population.”
The study’s patient population is complex with a high proportion suffering from severely calcified lesions. The mortality rate at four years was virtually identical between the two patient groups, at 15.6% for the Stellarex patient group and 15.2% for the control group. Secondary safety outcomes were also similar across the two groups. The four-year data also show a clinically relevant lower rate of clinically-driven target lesion revascularisation (CD-TLR) in the Stellarex DCB patient group of 28.2%, vs. 34.1% in the control group. CD-TLR is a commonly used indicator of treatment efficacy durability.
“The ILLUMENATE pivotal four-year data builds on the robust, consistent long-term data of the Stellarex clinical evaluation program,” said Chris Landon, general manager, Image Guided Therapy Devices at Philips. “We continue to make relevant data available to healthcare providers in order to help them make an informed decision on the optimal treatment for often complex disease patients with peripheral arterial disease.”