The Stellarex drug-coated balloon (DCB) is superior to percutaneous transluminal angioplasty (PTA) in the treatment of arterial disease in the superficial femoral and popliteal arteries, according to the results of the ILLUMENATE Trial presented Nov. 2 at TCT 2016.

In a multi-center, prospective, randomized trial, Sean Lyden, MD, et al., evaluated the safety and efficacy of the Stellarex DCB compared to PTA in 300 patients with arterial disease. At baseline, 43.9 percent of patients had severe calcification and 49.5 percent had diabetes. Follow-up occurred at 12-months post-procedure.

The results of the study showed that 93.6 percent of patients who received the DCB were free from clinically-driven target lesion revascularization at 12-month follow-up. Further, primary patency occurred in 82.3 percent of the DCB group. According to the authors of the study, these results reaffirm prior data from previous randomized trials. 

Keywords: Transcatheter Cardiovascular Therapeutics, Aneurysm, Cardiac Surgical Procedures, Angioplasty, Calcification, Physiologic, Calcinosis, Diabetes Mellitus, Follow-Up Studies, Prospective Studies

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