The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of polidocanol endovenous microfoam 0.5% and 1.0% compared with placebo for the treatment of saphenofemoral junction incompetence

Abstract

Objective VANISH-2 Investigator Group: K Gibson, Bellevue, WA, USA; M Goldman, San Diego, CA, USA; P Hertzman, Los Alamos, NM, USA; S Hirsch, Pittsburgh, PA, USA; R Hye, San Diego, CA, USA; M Isaacs, Walnut Creek, CA, USA; M Plaza-Ponte, Monroeville, PA, USA; S Rathbun, Oklahoma City, OK, USA; J Rhodes, Rochester, NY, USA; G Rosenberg, Frederick, MD, USA; M Schul, Lafayette, IN, USA; M Stanbro, Greenville, SC, USA; and R Weiss, Hunt Valley, MD, USA To determine efficacy and safety of polidocanol endovenous microfoam in treatment of symptoms and appearance in patients with saphenofemoral junction incompetence due to reflux of the great saphenous vein or major accessory veins. Method Patients were randomized equally to receive polidocanol endovenous microfoam 0.5%, polidocanol endovenous microfoam 1.0% or placebo. The primary efficacy endpoint was patient-reported improvement in symptoms, as measured by the change from baseline to Week 8 in the 7-day average electronic daily diary VVSymQ™ score. The co-secondary endpoints were the improvement in appearance of visible varicosities from baseline to Week 8, as measured by patients and by an independent physician review panel. Results In 232 treated patients, polidocanol endovenous microfoam 0.5% and polidocanol endovenous microfoam 1.0% were superior to placebo, with a larger improvement in symptoms (VVSymQ (−6.01 and–5.06, respectively, versus –2.00; P < 0.0001) and greater improvements in physician and patient assessments of appearance ( P < 0.0001). These findings were supported by the results of duplex ultrasound and other clinical measures. Of the 230 polidocanol endovenous microfoam-treated patients (including open-label patients), 60% had an adverse event compared with 39% of placebo; 95% were mild or moderate. No pulmonary emboli were detected and no clinically important neurologic or visual adverse events were reported. The most common adverse events in patients treated with polidocanol endovenous microfoam were retained coagulum, leg pain and superficial thrombophlebitis; most were related to treatment and resolved without sequelae. Conclusion Polidocanol endovenous microfoam provided clinically meaningful benefit in treating symptoms and appearance in patients with varicose veins. Polidocanol endovenous microfoam was an effective and comprehensive minimally invasive treatment for patients with a broad spectrum of vein disease (clinical, etiology, anatomy, pathophysiology clinical class C2 to C6) and great saphenous vein diameters ranging from 3.1 to 19.4 mm. Treatment with polidocanol endovenous microfoam was associated with mild or moderate manageable side effects. VVSymQ is an important new, validated instrument for symptom assessment in patients with varicose veins.