Two‐year results of a low‐dose drug‐coated balloon for revascularization of the femoropopliteal artery: Outcomes from the ILLUMENATE first‐in‐human study

OBJECTIVES: To assess the safety and effectiveness of the Stellarex™ drug‐coated angioplasty balloon (DCB) to inhibit restenosis in the superficial femoral and/or popliteal artery. BACKGROUND: Treatment of peripheral arterial disease is challenged by restenosis, requiring revascularization procedures to maintain patency. DCBs are designed to deliver an anti‐proliferative drug to the vessel wall to diminish smooth muscle cell proliferation and maintain patency. METHODS: This prospective, single‐arm, multicenter study enrolled 50 patients with 58 lesions in the first cohort that required pre‐dilatation with an uncoated angioplasty balloon prior to inflation of the DCB. The primary effectiveness endpoint was 6‐month late lumen loss (LLL). The major secondary endpoint was major adverse event (MAE) rate at 6 months, defined as cardiovascular death, amputation, and/or ischemia‐driven target lesion revascularization. RESULTS: The mean lesion length was 7.2 cm and baseline stenosis was 75.1%. Calcification was present in 62.1% of lesions and 12.1% were occluded. Both endpoints met their prespecified performance goals; at 6 months, the MAE rate was 4% and the mean LLL was 0.54 mm. The primary patency rate was 89.5% at 12 months and 80.3% at 24 months. The freedom from clinically‐driven target lesion revascularization rate, per Kaplan‐Meier estimate, was 90.0% at 12 months and 85.8% at 24 months. Additionally, there were no amputations or cardiovascular deaths reported through 24 months. CONCLUSIONS: The Stellarex DCB provides safe and durable clinical outcomes for treatment of femoropopliteal artery disease through 24 months. © 2015 Wiley Periodicals, Inc.