title: Two-year results of a low-dose drug-coated balloon for revascularization of the femoropopliteal artery: outcomes from the ILLUMENATE first-in-human study.
abstract: OBJECTIVE
  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.
authors.affiliation: Center for Diagnostic Radiology and Minimally Invasive Therapy, Jewish Hospital, Berlin, Germany.
authors.forename: Henrik
authors.initials: H
authors.lastname: Schroeder
authors.affiliation: Department of Diagnostic and Interventional Radiology, Hubertus-Hospital, Berlin, Germany.
authors.forename: Dirk-Roelfs
authors.initials: DR
authors.lastname: Meyer
authors.affiliation: Center for Diagnostic Radiology and Minimally Invasive Therapy, St. Joseph Hospital, Berlin, Germany.
authors.forename: Beata
authors.initials: B
authors.lastname: Lux
authors.affiliation: Center for Diagnostic Radiology and Minimally Invasive Therapy, Jewish Hospital, Berlin, Germany.
authors.forename: Ferdinand
authors.initials: F
authors.lastname: Ruecker
authors.affiliation: Center for Diagnostic Radiology and Minimally Invasive Therapy, Jewish Hospital, Berlin, Germany.
authors.forename: Marcello
authors.initials: M
authors.lastname: Martorana
authors.affiliation: Center for Diagnostic Radiology and Minimally Invasive Therapy, Jewish Hospital, Berlin, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Duda
mesh_terms: D000368:Aged; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D020099:Coated Materials, Biocompatible; D018572:Disease-Free Survival; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D005858:Germany; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D011446:Prospective Studies; D011474:Prosthesis Design; D011859:Radiography; D012008:Recurrence; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D062666:Vascular Access Devices; D014654:Vascular Patency
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel
keywords: claudication; paclitaxel-coated balloon; peripheral arterial disease