Network meta-analysis to compare VenaSeal with other superficial venous therapies for chronic venous insufficiency.

OBJECTIVE

Several randomized controlled trials (RCTs) have compared different interventions for chronic venous insufficiency (CVI) management, but mixed comparison of these interventions is lacking. The aim of this network meta-analysis was to compare VenaSeal closure system (Medtronic, Minneapolis, Minn) with endovenous laser ablation (EVLA), radiofrequency ablation (RFA), mechanochemical ablation, sclerotherapy, and surgery for management of CVI to achieve anatomic success (complete closure of treated vein within 6 months after intervention) as the primary outcome and health-related quality of life (HRQoL; EuroQol-5 Dimension, Aberdeen Varicose Vein Questionnaire), Venous Clinical Severity Score (VCSS), pain scores, and adverse events as secondary outcomes.

METHODS

A systematic review of journal databases was undertaken, and RCTs between January 1996 and September 2018 comparing different treatment options were included. Risk of bias and quality of publications were assessed using the Cochrane bias tool; Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were used for study selection and reporting. Twenty RCTs comprising 4570 patients were analyzed. Data for anatomic success, VCSS, HRQoL, pain score, and adverse events were extracted and analyzed using mixed treatment comparison in a network meta-analysis. A Bayesian fixed or random effects model was selected for analysis. Rank probability graphs were generated for various treatments and corresponding ranks obtained to estimate their probability of being best. Relative treatment effects were calculated in terms of log odds ratios for anatomic success and adverse events. Mean difference was calculated for VCSS, HRQoL, and pain score.

RESULTS

For the primary outcome measure (anatomic success), VenaSeal system had the highest probability of being ranked first (P = .980); RFA was ranked second (P = .365), EVLA third (P = .397), surgery fourth (P = .290), mechanochemical ablation fifth (P = .695), and sclerotherapy sixth (P = .982). For secondary outcome measures, VenaSeal system ranked third for VCSS (P = .332), fifth for EuroQol-5 Dimension (P = .420), and third for Aberdeen Varicose Vein Questionnaire (P = .300). Although, VenaSeal system was slightly inferior to some of the other interventions for HRQoL, the 95% credible interval of log odds ratio indicated insufficient evidence for any concrete conclusion to be drawn. VenaSeal system ranked first in reduction of postoperative pain score from baseline (P = .690) and was lowest in occurrence of adverse events (P = .650). Odds of occurrence of adverse events was 3.3 times in the sclerotherapy arm, 2.7 times in the EVLA arm, 1.6 times with surgery, and 1.1 times with RFA vs VenaSeal system arm.

CONCLUSIONS

VenaSeal system is a promising therapeutic option for anatomic success at 6 months, with fewer occurrences of adverse events (wound and groin infection, pulmonary embolism) in CVI patients compared with other interventions in this study. Additional economic analysis including cost-effectiveness analysis would provide interesting perspectives on real-world insights to patients, payers, and providers.