Kenneth L Todd1, David I Wright2. 1. Southeast Vein and Laser Center, Dothan, Ala. 2. BTG International, Philadelphia, Pa; BTG International, London, United Kingdom. Electronic address: david.wright@btgplc.com.
Abstract
OBJECTIVE: The objectives of this study were to assess the durability of response to treatment with polidocanol endovenous microfoam (Varithena; Provensis Ltd, a BTG International group company) and to assess the long-term safety of the study patients. METHODS: This report presents efficacy and safety data from the day after visit 5/week 8 (the primary end point of the study) through the 1-year study visit. As the approved dose concentration is 1%, this analysis focuses on those patients who were randomized to polidocanol endovenous microfoam 1% at study visit 2. Because the objective of the 1-year analysis was to assess the durability of response to treatment with polidocanol endovenous microfoam 1%, the 1-year efficacy analyses based on the efficacy population included all patients who were randomized and received at least one treatment with polidocanol endovenous microfoam 1%. Efficacy end points in the Polidocanol Endovenous Microfoam Versus Vehicle for the Treatment of Saphenofemoral Junction Incompetence (VANISH-2) trial were evaluated at 1 year (n = 221; 96% of those completed the primary end-point measurement at week 8) and included the following: Varicose Vein Symptoms Questionnaire (VVSymQ, Provensis Ltd) score, an assessment of symptoms by patients using electronic daily diaries; Independent Photography Review: Visible Varicose Veins (IPR-V(3)) and Patient Self-assessment of Visible Varicose Veins (PA-V(3)) scores, the assessment of appearance by an Independent Physician Review panel and by patient self-assessment, respectively; duplex ultrasound response (physiologic response to treatment); Venous Clinical Severity Score (disease severity); and Venous Insufficiency Epidemiological and Economic Study on Quality of Life (VEINES-QOL) score (quality of life). RESULTS: Of the 230 patients who completed visit 5/week 8, 56 receivedpolidocanol endovenous microfoam 1% at visit 2/week 0 and were subsequently assessed for efficacy at visit 5/week 8 and visit 10/1 year (one patient of the 57 who completed visit 5/week 8 received a nonpolidocanol endovenous microfoam intervention and was not included in the assessment). At 1 year after the first study treatment, patients treated with polidocanol endovenous microfoam demonstrated consistent, durable, and clinically meaningful improvements in symptoms, as measured by reductions in mean VVSymQ score; appearance, as measured by IPR-V(3) (clinician assessment) and PA-V(3) (patient self-assessment) scores; disease severity, as measured by the Venous Clinical Severity Score; and quality of life, as measured by the VEINES-QOL score. At 1 year, there were no new venous thrombus adverse events (VTAEs) and no clinically important sequelae in patients who had a VTAE in the study. In addition, there were no serious adverse events that were determined by the investigator to be related to the study drug. No new safety signals were identified. In patients who previously had a VTAE, none had a recurrence of thrombus or evidence of post-thrombotic syndrome at 1 year. CONCLUSIONS: Treatment with polidocanol endovenous microfoam 1% led to durable, clinically meaningful, and ongoing improvements at 1 year in varicose vein symptoms and appearance. Serious adverse events were those expected during long-term follow-up of the population of patients studied and were unrelated to treatment.
RCT Entities:
OBJECTIVE: The objectives of this study were to assess the durability of response to treatment with polidocanol endovenous microfoam (Varithena; Provensis Ltd, a BTG International group company) and to assess the long-term safety of the study patients. METHODS: This report presents efficacy and safety data from the day after visit 5/week 8 (the primary end point of the study) through the 1-year study visit. As the approved dose concentration is 1%, this analysis focuses on those patients who were randomized to polidocanol endovenous microfoam 1% at study visit 2. Because the objective of the 1-year analysis was to assess the durability of response to treatment with polidocanol endovenous microfoam 1%, the 1-year efficacy analyses based on the efficacy population included all patients who were randomized and received at least one treatment with polidocanol endovenous microfoam 1%. Efficacy end points in the Polidocanol Endovenous Microfoam Versus Vehicle for the Treatment of Saphenofemoral Junction Incompetence (VANISH-2) trial were evaluated at 1 year (n = 221; 96% of those completed the primary end-point measurement at week 8) and included the following: Varicose Vein Symptoms Questionnaire (VVSymQ, Provensis Ltd) score, an assessment of symptoms by patients using electronic daily diaries; Independent Photography Review: Visible Varicose Veins (IPR-V(3)) and Patient Self-assessment of Visible Varicose Veins (PA-V(3)) scores, the assessment of appearance by an Independent Physician Review panel and by patient self-assessment, respectively; duplex ultrasound response (physiologic response to treatment); Venous Clinical Severity Score (disease severity); and Venous Insufficiency Epidemiological and Economic Study on Quality of Life (VEINES-QOL) score (quality of life). RESULTS: Of the 230 patients who completed visit 5/week 8, 56 received polidocanol endovenous microfoam 1% at visit 2/week 0 and were subsequently assessed for efficacy at visit 5/week 8 and visit 10/1 year (one patient of the 57 who completed visit 5/week 8 received a nonpolidocanol endovenous microfoam intervention and was not included in the assessment). At 1 year after the first study treatment, patients treated with polidocanol endovenous microfoam demonstrated consistent, durable, and clinically meaningful improvements in symptoms, as measured by reductions in mean VVSymQ score; appearance, as measured by IPR-V(3) (clinician assessment) and PA-V(3) (patient self-assessment) scores; disease severity, as measured by the Venous Clinical Severity Score; and quality of life, as measured by the VEINES-QOL score. At 1 year, there were no new venous thrombus adverse events (VTAEs) and no clinically important sequelae in patients who had a VTAE in the study. In addition, there were no serious adverse events that were determined by the investigator to be related to the study drug. No new safety signals were identified. In patients who previously had a VTAE, none had a recurrence of thrombus or evidence of post-thrombotic syndrome at 1 year. CONCLUSIONS: Treatment with polidocanol endovenous microfoam 1% led to durable, clinically meaningful, and ongoing improvements at 1 year in varicose vein symptoms and appearance. Serious adverse events were those expected during long-term follow-up of the population of patients studied and were unrelated to treatment.