The Comparative Effectiveness of Non-compounded Polidocanol 1% Endovenous Microfoam (Varithena) Ablation versus Endovenous Thermal Ablation
Table of contents
Overview
The ongoing network meta-analysis (NMA) evaluates the evidence for Varithena (PEM) compared to endovenous thermal ablation (ETA) in treating chronic venous insufficiency (CVI). By distinguishing Varithena, the only FDA-approved, commercially available noncompounded polidoconol 1% endovenous microfoam ablation, from other foam sclerotherapy options, this NMA provides more precise and generalizable evidence on the relative effectiveness and safety of these treatments.
Key findings
Polidocanol 1% endovenous microfoam (Varithena) was not statistically different from endovenous thermal ablation (ETA) for venous closure from 3 months up to 6 years
PEM (Varithena) had higher odds for vein closure and was statistically significantly differentiated from PCF from 3 months up to 6 years
- A sensitivity analysis found venous closure findings were robust at follow-up intervals of 12 months or greater and up to 6 years
There is no evidence that Varithena is associated with an increased risk of DVT compared to endovenous thermal ablation or PCF treatment
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Objective
This study compares the effectiveness and safety of polidocanol 1% endovenous microfoam ablation (Varithena) versus endovenous thermal ablation with radiofrequency or laser energy for treatment of venous insufficiency caused by lower extremity truncal vein incompetence, via network meta-analysis of published comparative evidence.
Inclusion criteria
Time period
Studies published between January 2000 and January 2023
Inclusions
Eligible studies were defined as CVI treatment studies with a randomized or non-randomized comparison to at least one of the two treatments of interest (PEM or ETA).
Exclusions
Single-arm studies, treatments not targeted to truncal veins, and studies without a common comparison of interest (i.e., an alternate treatment used in at least one PEM study and one thermal study).
Primary outcomes
The primary effectiveness outcomes were closure rate (occlusion) at time points of at least 3 months post-procedure, mean or median change in the Venous Clinical Severity Score (VCSS, or its revised version, rVCSS) and venous ulcer healing rate.
Secondary outcomes
Secondary outcomes were safety (including total procedural complications, deep vein thrombosis (DVT) and any reported sequelae of thrombotic events), patient-reported outcomes (including quality of life), symptom improvement, and patient preference.
Included studies
Study count by continent
PRISMA Study Attrition Diagram
PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) is a set of guidelines for reporting systematic reviews and meta-analyses. This PRISMA-recommended diagram maps out the flow of evidence from the literature search through the screening process.
Preferred Reporting Items for Systematic Reviews and Meta-Analyses. It is an evidence-based minimum set of items for reporting in systematic reviews and meta-analyses. The PRISMA statement consists of a 27-item checklist and a 4-phase flow diagram.
NMA = network meta-analysis
MA = meta-analysis
f/u = follow-up
Linked studies are additional publication(s) reporting on the same or overlapping patient population as the primary study. We grouped inked studies for data extraction to comprehensively represent outcomes without double-counting patient results.
Indications
Varithena® (polidocanol injectable foam) is indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins and visible varicosities of the great saphenous vein (GSV) system above and below the knee. Varithena® improves the symptoms of superficial venous incompetence and the appearance of visible varicosities.
Important Safety Information
The use of Varithena® is contraindicated in patients with known allergy to polidocanol and those with acute thromboembolic disease. Severe allergic reactions have been reported following administration of liquid polidocanol, including anaphylactic reactions, some of them fatal. Observe patients for at least 10 minutes following injection and be prepared to treat anaphylaxis appropriately. Intra-arterial injection or extravasation of polidocanol can cause severe necrosis, ischemia or gangrene. Patients with underlying arterial disease may be at increased risk for tissue ischemia. If intra-arterial injection of polidocanol occurs, consult a vascular surgeon immediately. Varithena® can cause venous thrombosis. Follow administration instructions closely and monitor for signs of venous thrombosis after treatment. Patients with reduced mobility, history of deep vein thrombosis or pulmonary embolism, or recent (within 3 months) major surgery, prolonged hospitalization, or pregnancy are at increased risk for developing thrombosis. The most common adverse events observed were pain/discomfort in extremity, retained coagulum, injection site hematoma or pain, common femoral vein thrombus extension, superficial thrombophlebitis, and deep vein thrombosis. Physicians administering Varithena® must be experienced with venous procedures, possess a detailed working knowledge of the use of the duplex ultrasound in venous disease and be trained in the administration of Varithena®.
See Full Prescribing Information for Varithena®