Study shows reduction in symptom burden in patients with varicose veins caused by saphenofemoral junction incompetence with PEM treatment
BTG, the specialist healthcare company, have announced the online publication of VANISH-2, a study in which patients with symptomatic and visible varicose veins caused by saphenofemoral junction (SFJ) incompetence were treated with polidocanol endovenous microfoam (PEM).
VANISH-2, the first of two US pivotal Phase III trials of PEM, was published online in the journal Phlebology (PHL) on July 17, 2013. The first author, Dr. Kenneth Todd, MD, an American College of Phlebology Committee Member from the Southeast Vein and Laser Center, was a Principal Investigator for VANISH-2.
Full data from the published study indicate that PEM provides a clinically meaningful benefit in treating symptoms and appearance in patients with varicose veins caused by SFJ reflux. The study achieved all primary, secondary and tertiary efficacy endpoints in patients with vein diameters ranging from 3.1 to 19.4 mm.
Patients treated with PEM demonstrated a statistically significant improvement in symptoms at week eight, the study primary endpoint as measured by the VVSymQ(TM) score, compared with patients who received placebo (P<0.0001). The VVSymQ(TM) score is a patient-reported outcome measure of varicose vein symptom burden. The study’s co-secondary endpoint, improvement of appearance as measured by both a patient-reported outcome (PA-V(3)) and by a blinded independent panel review of photographs (IPR-V(3)), was also met. Patients treated with PEM achieved a statistically significant improvement in appearance in both the PA-V(3) and IPR-V(3) scores compared with patients who received placebo (P<0.0001 for both).
At week eight, eight out of 10 patients in the pooled PEM group (composed of PEM 0.5% and PEM 1.0%) reported clinically meaningful improvements in symptoms compared to 20 percent in the placebo group. Additionally, treatment with PEM was superior to placebo in improving symptoms when either a duration or intensity scale was used to measure patients’ symptoms. The improvement in symptoms was supported by statistically significant improvements in the Venous Clinical Severity Score (VCSS) and Venous Insufficiency Epidemiological and Economic Study-Quality of Life (VEINES-QOL) score compared to placebo.
Elimination of SFJ reflux and/or complete occlusion of the target vein(s) at week eight, a tertiary endpoint, was achieved by 85 percent of patients in the pooled PEM group (P=.0002, compared with the control group PEM 0.125%). This endpoint was achieved in 83 percent and 86 percent of patients receiving PEM 0.5% and PEM 1.0%, respectively.
There were no serious or unexpected adverse events associated with the use of PEM. No pulmonary emboli were detected and no clinically important neurologic or visual adverse events were reported. Of the 230 PEM-treated patients (including open-label patients), 60 percent had an adverse event compared with 39 percent of placebo; 95 percent were mild or moderate. The most common adverse events in patients treated with PEM were retained coagulum, leg pain and superficial thrombophlebitis; most were related to treatment and resolved without sequelae.
“VANISH-2 is an important study because it is the first time improvement in symptoms has been shown using a patient-reported outcome measure in a randomized controlled clinical trial in patients with varicose veins,” said Todd. “The publication of the full results for VANISH-2 demonstrates that PEM, if approved, could offer a new treatment option for patients with symptomatic varicose veins.”
PEM is a patent-protected experimental drug/device combination product that produces engineered polidocanol endovenous microfoam and was manufactured in accordance with GMP standards for the clinical trial. PEM is delivered from a canister through a syringe into the incompetent vein under ultrasound guidance. PEM first displaces blood and then the polidocanol chemically ablates the inner lining of the vein wall, causing the vein to close. A compression bandage and stocking are worn continuously for the first 48 hours, and the compression stocking only is worn day and night for an additional 12 days.