Objective: To compare the effectiveness and safety of polidocanol 1% endovenous microfoam ablation 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.
Methods: We conducted a systematic literature review, following best practices including a prospective protocol. We screened studies published in English from 2000 to 2023 for randomized or non-randomized studies reporting direct or indirect comparisons between polidocanol 1% endovenous microfoam and endovenous thermal ablation. Thirteen studies met our eligibility criteria for the network meta-analysis. The co-primary effectiveness outcomes were closure rate at least 3 months post-procedure, and average change in Venous Clinical Severity Score. For the subgroup of venous ulcer patients, ulcer healing rate was the primary effectiveness outcome. Secondary outcomes included safety and patient-reported outcomes. Network meta-analyses were conducted on outcomes having sufficient data. Categorical outcomes were summarized using odds ratios with 95% confidence intervals. Sensitivity tests and estimates of network inconsistency were employed to investigate the robustness of our meta-analysis.
Results: We found that polidocanol 1% endovenous microfoam was not statistically different from endovenous thermal ablation for venous closure (OR 0.65, 95% CI 0.36 to 1.18, P=0.16). While not the primary aim of the study, the network meta-analysis also provided evidence to confirm our supposition that polidocanol 1% endovenous microfoam was statistically differentiated from physician-compounded foam, with higher odds for vein closure (OR 2.91, 95% CI 1.58 to 5.37, P<0.01). A sensitivity analysis using the longest available time point for closure in each study, with minimum 12 month follow-up (median 48 months, range 12-72 months), showed results similar to the main analysis. No association was found between the risk of deep vein thrombosis and the treatment received. Available data were insufficient for network meta-analysis of Venous Clinical Severity Score improvement and ulcer healing rates.
Conclusions: Polidocanol 1% endovenous microfoam was not statistically different from endovenous thermal ablation for venous closure and deep vein thrombosis risk for chronic venous insufficiency treatment, based on a network meta-analysis of published evidence. Polidocanol 1% endovenous microfoam was statistically significantly differentiated from physician-compounded foam, with higher odds of vein closure. A sensitivity analysis found venous closure findings were robust at follow-up intervals of 12 months or greater and up to 6 years. New evidence meeting inclusion criteria for this review will be incorporated at regular intervals to a living network meta-analysis.
Keywords: Chronic venous insufficiency; Network meta-analysis; Polidocanol 1% endovenous microfoam; Varicose veins.
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