ILLUMENATE pivotal trial of Stellarex confirms safety profile in peripheral arterial disease.- Royal Philips

Royal Philips announced the four-year results from the randomized controlled ILLUMENATE Pivotal trial of Stellarex (low-dose Drug-Coated Balloon) in patients with peripheral arterial disease in the U.S. With an excellent follow-up compliance rate of over 95% in a highly complex disease patient cohort, the data show similar mortality rates through four years for patients treated with Stellarex compared to those treated with the current standard of care (plain balloon angioplasty). 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 .035? low-dose DCB in restoring and maintaining blood flow in the superficial femoral artery and popliteal arteries of patients with peripheral arterial disease. The results were evaluated compared to percutaneous transluminal angioplasty (PTA) treatment with uncoated balloons, the current standard of care. 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 revascularization (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 results were presented at the Leipzig Interventional Course.Comment:The Stellarex DCB uses EnduraCoat technology, a durable, uniform coating designed to prevent drug loss during transit and facilitate controlled, efficient drug delivery to the treatment site.