A LIVING NETWORK META-ANALYSIS FRAMEWORK FOR COMPARATIVE EFFECTIVENESS RESEARCH IN CHRONIC VENOUS INSUFFICIENCY TREATMENT
Author(s)
Wendy Wifler, MBA1, Dirk Sutherland, BS1, Diana Frame, MPH2, Larry Gache, MS3, Candace Gunnarsson, EdD, MA4.
1Boston Scientific, Maple Grove, MN, USA, 2Frame Research, LLC, Brooklyn, NY, USA, 3LGache Statistical Consulting LLC, Oakwood, OH, USA, 4Gunnarsson Consulting, Boise, ID, USA.
1Boston Scientific, Maple Grove, MN, USA, 2Frame Research, LLC, Brooklyn, NY, USA, 3LGache Statistical Consulting LLC, Oakwood, OH, USA, 4Gunnarsson Consulting, Boise, ID, USA.
OBJECTIVES: To describe the development and implementation of a living network meta-analysis (LNMA) for continuously evaluating comparative treatment effectiveness in chronic venous insufficiency, a setting with multiple treatment options but limited randomized trials. The LNMA compares FDA-approved commercially manufactured polidocanol 1% endovenous microfoam (PEM) ablation versus endovenous thermal ablation (ETA) with radiofrequency or laser energy. Our approach was atypical in that the research sponsor committed prospectively to ongoing updates of the LNMA.
METHODS: We established an LNMA framework building on a peer-reviewed NMA comparing PEM and ETA. The baseline systematic review, registered in PROSPERO, searched English-language publications (2000-2023) following PRISMA guidelines with clinical expert input. Eligible studies included randomized and non-randomized comparisons of PEM or ETA versus any comparator. Network connectivity relied on common comparators (surgery, physician-compounded foam) and limited head-to-head studies. The protocol specifies systematic surveillance, predetermined eligibility criteria, standardized data extraction, and consistent statistical methods. Primary outcomes are vein closure rates and Venous Clinical Severity Score changes; secondary outcomes include DVT. Results from LNMA updates are posted on a publicly accessible, industry-sponsored website with transparent documentation.
RESULTS: The baseline NMA (13 studies, 233,801 patients) demonstrated no significant difference between PEM and ETA for closure rates (OR 0.65, 95% CI 0.36-1.18) or DVT risk. The LNMA framework enables timely incorporation of emerging evidence while maintaining methodological rigor; to date, initial findings have remained robust. Quarterly surveillance and approximately annual website updates ensure stakeholders access current synthesized evidence. Updates based on preset methods have been efficient in terms of effort.
CONCLUSIONS: This LNMA represents a novel application of living evidence synthesis methodology in the venous disease space. The approach balances scientific rigor with practical implementation through industry partnership, offering a model for maintaining current comparative effectiveness evidence in evolving treatment landscapes. This framework could be a template for conditions requiring ongoing evidence monitoring.
METHODS: We established an LNMA framework building on a peer-reviewed NMA comparing PEM and ETA. The baseline systematic review, registered in PROSPERO, searched English-language publications (2000-2023) following PRISMA guidelines with clinical expert input. Eligible studies included randomized and non-randomized comparisons of PEM or ETA versus any comparator. Network connectivity relied on common comparators (surgery, physician-compounded foam) and limited head-to-head studies. The protocol specifies systematic surveillance, predetermined eligibility criteria, standardized data extraction, and consistent statistical methods. Primary outcomes are vein closure rates and Venous Clinical Severity Score changes; secondary outcomes include DVT. Results from LNMA updates are posted on a publicly accessible, industry-sponsored website with transparent documentation.
RESULTS: The baseline NMA (13 studies, 233,801 patients) demonstrated no significant difference between PEM and ETA for closure rates (OR 0.65, 95% CI 0.36-1.18) or DVT risk. The LNMA framework enables timely incorporation of emerging evidence while maintaining methodological rigor; to date, initial findings have remained robust. Quarterly surveillance and approximately annual website updates ensure stakeholders access current synthesized evidence. Updates based on preset methods have been efficient in terms of effort.
CONCLUSIONS: This LNMA represents a novel application of living evidence synthesis methodology in the venous disease space. The approach balances scientific rigor with practical implementation through industry partnership, offering a model for maintaining current comparative effectiveness evidence in evolving treatment landscapes. This framework could be a template for conditions requiring ongoing evidence monitoring.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
SA37
Topic
Study Approaches
Topic Subcategory
Meta-Analysis & Indirect Comparisons
Disease
SDC: Cardiovascular Disorders (including MI, Stroke, Circulatory)