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 non-compounded polidocanol 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.
Original NMA publication date: April 26, 2024
Latest update to this webpage: July 1, 2024
This living network meta-analysis will be updated approximately quarterly.
Key findings
- Finding 1 & 2
- Finding 3
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.
To learn more, view the publication
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 three 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
| Number of studies | Number of patients | |
|---|---|---|
| Total | 13 | 233,801 |
| Location | ||
| North America | 4 | 196,234 |
| Europe | 5 | 37,266 |
| Asia | 2 | 122 |
| Other* | 2 | 178 |
| Industry sponsorship | ||
| Yes | 3 | 145,878 |
| None reported | 10 | 87,923 |
| Study design | ||
| RCT | 6 | 2,034 |
| Comparative non-RCT | 7 | 231,767 |
| Special patient population | ||
| Female | 1 | 80 |
| Small saphenous vein (SSV) | 2 | 311 |
RCT = randomized controlled trial
Comparative non-RCTs could be prospective or retrospective; includes 3 large real-world data studies (Mallick 2016, Pappas 2021, Sutton 2012)
*Other location: Egypt, Chile
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.