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A multicenter, randomized, placebo-controlled study to evaluate the efficacy and safety of Varithena® (polidocanol endovenous microfoam 1%) for symptomatic, visible varicose veins with saphenofemoral junction incompetence.

ABSTRACT: Objectives A randomized, placebo-controlled, multicenter study was conducted to evaluate the safety and efficacy of polidocanol endovenous microfoam (1%, Varithena® [polidocanol injectable foam], BTG International Ltd.). Methods Patients (n?=?77) with symptomatic, visible varicose veins were randomized to treatment with either Varithena 1% or placebo. Results Varithena provided greater mean changes from Baseline in patient-reported assessments of symptoms (e.g., heaviness, achiness, swelling, throbbing, itching [HASTI®] score 30.7 points vs 16.7 points, p?=?0.0009, primary endpoint; and modified Venous Insufficiency Epidemiological and Economic Study-Quality-of-Life/Symptoms [m-VEINES-QOL/Sym; p??0.9, p???0.001). Adverse events included contusion, incision-site hematoma, and limb discomfort. Venous thrombus adverse events were reported as mild and generally resolved without sequelae. Conclusions Varithena provided significantly greater symptom relief and improvement in leg appearance compared with placebo. Adverse events were generally mild and transient. ( www.clinicaltrials.gov [NCT00758420]).

SUBMITTER: Gibson K

PROVIDER: S-EPMC5405826 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

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A multicenter, randomized, placebo-controlled study to evaluate the efficacy and safety of Varithena® (polidocanol endovenous microfoam 1%) for symptomatic, visible varicose veins with saphenofemoral junction incompetence.

Gibson Kathleen K Kabnick Lowell L

Phlebology 20160709 3

Objectives A randomized, placebo-controlled, multicenter study was conducted to evaluate the safety and efficacy of polidocanol endovenous microfoam (1%, Varithena® [polidocanol injectable foam], BTG International Ltd.). Methods Patients (n = 77) with symptomatic, visible varicose veins were randomized to treatment with either Varithena 1% or placebo. Results Varithena provided greater mean changes from Baseline in patient-reported assessments of symptoms (e.g., heaviness, achiness, swelling, th ...[more]

PMID: 27013511

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Project description:ObjectiveTo compare foam bubble size and bubble size distribution, stability, and degradation rate of commercially available polidocanol endovenous microfoam (Varithena®) and physician-compounded foams using a number of laboratory tests.MethodsFoam properties of polidocanol endovenous microfoam and physician-compounded foams were measured and compared using a glass-plate method and a Sympatec QICPIC image analysis method to measure bubble size and bubble size distribution, Turbiscan™ LAB for foam half time and drainage and a novel biomimetic vein model to measure foam stability. Physician-compounded foams composed of polidocanol and room air, CO2, or mixtures of oxygen and carbon dioxide (O2:CO2) were generated by different methods.ResultsPolidocanol endovenous microfoam was found to have a narrow bubble size distribution with no large (>500 µm) bubbles. Physician-compounded foams made with the Tessari method had broader bubble size distribution and large bubbles, which have an impact on foam stability. Polidocanol endovenous microfoam had a lower degradation rate than any physician-compounded foams, including foams made using room air (p < 0.035). The same result was obtained at different liquid to gas ratios (1:4 and 1:7) for physician-compounded foams. In all tests performed, CO2 foams were the least stable and different O2:CO2 mixtures had intermediate performance. In the biomimetic vein model, polidocanol endovenous microfoam had the slowest degradation rate and longest calculated dwell time, which represents the length of time the foam is in contact with the vein, almost twice that of physician-compounded foams using room air and eight times better than physician-compounded foams prepared using equivalent gas mixes.ConclusionBubble size, bubble size distribution and stability of various sclerosing foam formulations show that polidocanol endovenous microfoam results in better overall performance compared with physician-compounded foams. Polidocanol endovenous microfoam offers better stability and cohesive properties in a biomimetic vein model compared to physician-compounded foams. Polidocanol endovenous microfoam, which is indicated in the United States for treatment of great saphenous vein system incompetence, provides clinicians with a consistent product with enhanced handling properties.

Project description:AIM:To assess the feasibility and technical success of endovenous laser ablation (EVLA) of recurrent varicose veins arising from the former sapheno-femoral junction (SFJ). METHODS:We retrospectively analyzed all EVLA procedures treated in our institution by one surgeon between March 2019 and April 2020 and selected all consecutive cases with SFJ recurrence occuring after surgical high ligation and stripping or endovenous thermal ablation for incompetence of the great saphenous vein (GSV) in superficial venous insufficiency. The feasibility, technical success as determined by duplex ultrasound on the postoperative visit, complications and rate of endothermal heat-induced thrombosis (EHIT) were recorded. A subgroup definition was performed based on sonographic morphology of the recurrence and resulting strategy of ablation. RESULTS:Thirty-five limbs with SFJ recurrence in 34 patients were treated with EVLA in order to shut down the highest refluxing point. In 22 interventions, it was required to switch off a short stump or a neovascularization by direct puncture (Subgroup 1). In 13 treatments, the presence of residual GSV segments, or persistent, varicose transformed major tributaries like the anterior accessory great saphenous vein, enabled cannulation and advancing the laser fiber from distal to the former SFJ (Subgroup 2). The EVLA procedures could be successfully carried out in all 35 cases. There were no major complications, no thromboembolism or EHIT, and no local groin complications. In one case, the patient developed a phlebitic response that required temporary medication. Technical success was achieved with 34/35 treatments (97.1%). When comparing the subgroups, the morphological pattern of the SFJ recurrence and the resulting technique of puncture, cannulation and ablation did not influence the result. CONCLUSIONS:The results of this case series suggest that SFJ recurrences can also be successfully treated in situations where there are tortuous or short stumps that require direct puncture and ablation.

Project description:BACKGROUND:Varicose veins are a common problem with no approved medical therapies. Although it is believed that varicose vein pathogenesis is multifactorial, there is limited understanding of the genetic and environmental factors that contribute to their formation. Large-scale studies of risk factors for varicose veins may highlight important aspects of pathophysiology and identify groups at increased risk for disease. METHODS:We applied machine learning to agnostically search for risk factors of varicose veins in 493?519 individuals in the UK Biobank. Predictors were further studied with univariable and multivariable Cox regression analyses (2441 incident events). A genome-wide association study of varicose veins was also performed among 337?536 unrelated individuals (9577 cases) of white British descent, followed by expression quantitative loci and pathway analyses. Because height emerged as a new candidate risk factor, we performed mendelian randomization analyses to assess a potential causal role for height in varicose vein development. RESULTS:Machine learning confirmed several known (age, sex, obesity, pregnancy, history of deep vein thrombosis) and identified several new risk factors for varicose vein disease, including height. After adjustment for traditional risk factors in Cox regression, greater height remained independently associated with varicose veins (hazard ratio for upper versus lower quartile, 1.74; 95% CI, 1.51-2.01; P<0.0001). A genome-wide association study identified 30 new genome-wide significant loci, identifying pathways involved in vascular development and skeletal/limb biology. Mendelian randomization analysis provided evidence that increased height is causally related to varicose veins (inverse-variance weighted: odds ratio, 1.26; P=2.07×10-16). CONCLUSIONS:Using data from nearly a half-million individuals, we present a comprehensive genetic and epidemiological study of varicose veins. We identified novel clinical and genetic risk factors that provide pathophysiological insights and could help future improvements of treatment of varicose vein disease.

Dataset Information

A multicenter, randomized, placebo-controlled study to evaluate the efficacy and safety of Varithena® (polidocanol endovenous microfoam 1%) for symptomatic, visible varicose veins with saphenofemoral junction incompetence.

Publications

A multicenter, randomized, placebo-controlled study to evaluate the efficacy and safety of Varithena® (polidocanol endovenous microfoam 1%) for symptomatic, visible varicose veins with saphenofemoral junction incompetence.

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