title: A multicenter, randomized, placebo-controlled trial of endovenous thermal ablation with or without polidocanol endovenous microfoam treatment in patients with great saphenous vein incompetence and visible varicosities.
abstract: Objectives * Varithena 017 Investigator Group: Michael Vasquez, MD, Venous Institute of Buffalo, Amherst, NY; Antonios Gasparis, MD, Stony Brook University Medical Center, Stony Brook, NY; Kathleen Gibson, MD, Lake Washington Vascular, Bellevue, WA; James Theodore King, MD, Vein Clinics of America, Oakbrook Terrace, IL; Nick Morrison, MD, Morrison Vein Institute, Scottsdale, AZ; Girish Munavalli, MD, Dermatology, Laser & Vein Specialists of the Carolinas, Charlotte, NC; Eulogio J. Sanchez, MD, Batey Cardiovascular Center, Bradenton, FL. Varithena® is a trademark of Provensis Ltd, a BTG International group company. To determine the efficacy and safety of polidocanol endovenous microfoam (PEM 0.5%, 1.0%) and placebo each administered with endovenous thermal ablation. Methods A multicenter, randomized, placebo-controlled, blinded study was conducted in patients with great saphenous vein incompetence and symptomatic and visible superficial venous disease. Co-primary endpoints were physician-assessed and patient-assessed appearance change from Baseline to Week 8. Results A total of 117 patients received treatment (38 placebo, 39 PEM 0.5%, 40 PEM 1%). Physician-rated vein appearance at Week 8 was significantly better with PEM ( p = 0.001 vs. placebo); patient-assessed appearance trended similarly. Polidocanol endovenous microfoam provided improvements in clinically meaningful change in patient-assessed and physician-assessed appearance ( p < 0.05), need for additional treatment ( p < 0.05), saphenofemoral junction reflux elimination, symptoms, and QOL. In PEM recipients, the most frequent adverse event was superficial thrombophlebitis (35.4%) Conclusions Endovenous thermal ablation + PEM significantly improved physician-assessed appearance at Week 8, increased the proportion of patients with a clinically meaningful change in appearance, and reduced need for additional treatment. www.clinicaltrials.gov (NCT01197833).
authors.affiliation: 1 SUNY Buffalo Department of Surgery, Buffalo, NY, USA.|2 The Venous Institute of Buffalo, Amherst, NY, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Vasquez
authors.affiliation: 3 Division of Vascular Surgery, Stony Brook School of Medicine, Stony Brook, NY, USA.|4 Stony Brook Vein Center, Manhasset, NY, USA.
authors.forename: Antonios P
authors.initials: AP
authors.lastname: Gasparis
mesh_terms: D000328:Adult; D000368:Aged; D057510:Endovascular Procedures; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077423:Polidocanol; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D012501:Saphenous Vein; D013924:Thrombophlebitis / Q000628:therapy*; D014648:Varicose Veins / Q000628:therapy*; D014689:Venous Insufficiency / Q000628:therapy*
chemical_list: D000077423:Polidocanol; D011092:Polyethylene Glycols
keywords: Varicose veins; polidocanol; polidocanol injectable microfoam; saphenous vein; self-report