Published VANISH-1 Data Show Benefit of BTG's Varithena for GSV Varicosities

December 8, 2015—Findings from the VANISH-1 trial were published by J. Theodore King, MD, et al in the European Journal of Vascular and Endovascular Surgery (EJVES; 2015;50:784–793).

The multicenter, parallel-group VANISH-1 trial investigated the treatment of truncal incompetence and varicose veins using a new pharmaceutical-grade polidocanol endovenous microfoam (PEM) preparation. The PEM is now approved and available in the United States as Varithena polidocanol injectable foam (BTG International Ltd.).

In November 2013, BTG announced that the US Food and Drug Administration approved Varithena for the treatment of patients with incompetent veins and visible varicosities of the great saphenous vein (GSV) system. The company launched Varithena in August 2014.

The VANISH-1 study was designed to determine if a single administration of ≤ 15 mL of PEM could alleviate symptoms and improve appearance of varicose veins in a typical population of patients with moderate to very severe symptoms of superficial venous incompetence and visible varicosities of the GSV system.

As summarized in EJVES, the primary endpoint was patient-reported venous symptom improvement, as measured by change from baseline to Week 8 in 7-day average VVSymQ score for quantifying varicose vein symptoms.

The VVSymQ electronic daily diary is a patient-reported outcomes instrument that measures the burden of varicose vein symptoms. The VVSymQ score measures the five most relevant symptoms to patients: heaviness, achiness, swelling, throbbing, and itching. The scores range from 0 to 25, with 0 representing no symptoms, and 25 representing all five symptoms experienced all of the time.

Co-secondary endpoints measured improvement in appearance of visible varicose veins from baseline to Week 8, as measured by the Independent Photography Review–Visible Varicose Veins (IPR-V³) and Patient Self-assessment of Visible Varicose Veins (PA-V³) scores. Patients were randomized to five groups: PEM 0.125% (control), 0.5%, 1%, 2%, or placebo. Adverse events were recorded at each study visit. Tertiary endpoints measured duplex ultrasound response, changes in venous clinical severity score, and the modified Venous Insufficiency Epidemiological and Economic Study–Quality of Life/Symptoms.

At Week 8, VVSymQ scores for the pooled PEM group (0.5% + 1% + 2%; P < .0001) and individual dose concentrations (P < .001) were significantly superior to placebo. Mean changes from baseline to Week 8 in IPR-V³ and PA-V³ scores were significantly greater for pooled PEM than for placebo (P < .0001). Most adverse events were mild and resolved without sequelae. No pulmonary emboli were reported.

The investigators concluded that a single administration of up to 15 mL of PEM is a safe, effective, and convenient treatment for the symptoms of superficial venous incompetence and the appearance of visible varicosities of the GSV system. Doses of 0.5%, 1%, and 2% PEM appear to have an acceptable risk-benefit ratio, advised the VANISH-1 investigators in EJVES.