Comparative effectiveness of non-compounded polidocanol 1% endovenous microfoam (Varithena) ablation versus endovenous thermal ablation utilizing a systematic review and network meta-analysis.

Autor: Kabnick LS; Vein and Lymphatic University, Lake Worth, FL. Electronic address: LSK@lowellkabnickmd.com., Jimenez JC; Division of Vascular and Endovascular Surgery, David Geffen School of Medicine at University of California, Los Angeles, CA., Coogan SM; UT Health Houston, McGovern Medical School, Houston, TX., Gache L; LGache Statistical Consulting, Oakwood, OH., Frame D; Frame Research, Brooklyn, NY., Gunnarsson C; Gunnarsson Consulting, Jupiter, FL., Ozsvath K; Samaritan Hospital, Troy, NY; St. Peter's Vascular Associates, St. Peter's Medical Associates, Albany, NY.
Jazyk: angličtina
Zdroj: Journal of vascular surgery. Venous and lymphatic disorders [J Vasc Surg Venous Lymphat Disord] 2024 Nov; Vol. 12 (6), pp. 101896. Date of Electronic Publication: 2024 Apr 26.
DOI: 10.1016/j.jvsv.2024.101896
Abstrakt: Objective: We compared the effectiveness and safety of polidocanol 1% endovenous microfoam ablation vs 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 and nonrandomized 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 the closure rate ≥3 months after procedure and the average change in the Venous Clinical Severity Score. For the subgroup of venous ulcer patients, the ulcer healing rate was the primary effectiveness outcome. The 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 (ORs) with 95% confidence intervals (CIs). Sensitivity tests and estimates of network inconsistency were used to investigate the robustness of our meta-analysis.
Results: We found that polidocanol 1% endovenous microfoam was not significantly different statistically from endovenous thermal ablation for venous closure (OR, 0.65; 95% CI, 0.36-1.18; P = .16). Although not the primary aim of the study, the network meta-analysis also provided evidence to confirm our supposition that polidocanol 1% endovenous microfoam was significantly differentiated statistically from physician-compounded foam, with higher odds for vein closure (OR, 2.91; 95% CI, 1.58-5.37; P < .01). A sensitivity analysis using the longest available time point for closure in each study, with a minimum of 12 months of follow-up (median, 48 months; range, 12-72 months), showed results similar to those of the main analysis. No association was found between the risk of deep vein thrombosis and the treatment received. The available data were insufficient for a network meta-analysis of Venous Clinical Severity Score improvement and ulcer healing rates.
Conclusions: Polidocanol 1% endovenous microfoam was not significantly different statistically 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 significantly differentiated statistically 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 for up to 6 years. New evidence meeting the inclusion criteria for this review will be incorporated at regular intervals into a living network meta-analysis.
Competing Interests: Disclosures L.S.K. provides education and consulting services to Boston Scientific, Beck and Dickinson, Amsel Medical, and AngioDynamics. J.C.J. is a consultant and speaker for Boston Scientific. S.M.C., L.G., D.F., and C.G. are consultants for Boston Scientific. K.O. is a speaker/advisory consultant for Boston Scientific, Medtronic, Terumo and Convatec; primary investigator for the W.L. Gore & Associates Venous stent trial; primary investigator for SAAVE study enVVeno Medical Corporation, serves on the Intersocietal Accreditation Commission Vascular Interventional Board; and is a Capital District Physicians’ Health Plan committee member.
(Copyright © 2024. Published by Elsevier Inc.)
Databáze: MEDLINE
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