Longer term follow-up of a randomized controlled trial on the role of compression after radiofrequency ablation of varicose veins.

Abstract

Objective: Several studies have shown that, in the short term, treatment outcomes following endothermal ablation of varicose veins without the prescription of post procedural compression are not inferior to outcomes when compression is routinely prescribed. This follow-up to our randomized controlled trial (RCT) published in 2020 explores whether the non-inferiority persists into the medium to long term.

Methods: All 94 patients from the RCT were recalled at 27 months after their initial radiofrequency ablation (RFA) procedure. The procedural details, randomization, and inclusion and exclusion criteria were described in the original RCT paper. Consent was obtained for further venous duplex ultrasound scan at 27 to 61 months after the initial procedure. The successful target vein closure at this juncture represented our primary outcome. Secondary outcomes include disease severity, measured using the Aberdeen Varicose Vein Severity Score (AVSS) and the Revised Venous Clinical Severity Score (RVCSS), post-procedural pain measured using Likert scale, and number of days taken for patients to return to work or normal activities.

Results: Thirty-one of 48 patients (64.6%) in the compression group and 29 of 46 patients (63%) in the no-compression group were evaluated. The mean duration of follow-up was 43 and 42 months in the compression and no-compression group, respectively. The target vein occlusion rate evaluated at this longer-term follow up were 80.7% and 79.3% in the compression and no-compression groups, respectively. There was no significant difference between the two groups (P = .37). Secondary outcomes of quality of life and disease severity measured using AVSS and RVCSS showed no significant difference between the two groups (post-procedural AVSS mean score 5.2 in the compression group vs 8.3 in the no-compression group [95% confidence interval (CI), -7.3 to 1.1; P = .14]; post-procedural RVCSS mean score 1.5 in the compression group vs 1.8 in the no-compression group [95% CI, -1.1 to 0.7; P = .59]). Patient satisfaction was similar in both groups (mean score 6.4 in the compression group vs 5.9 in the no-compression group [95% CI, -0.22 to 1.17; P = .18]), and the number of days taken for patients to return to work were also comparable (mean of 11.9 days in the compression group vs 12.6 days in the no-compression group [95% CI, -7.7 to 6.2; P = .83]).

Conclusions: This study provided some evidence to support no additional benefit of compression use after RFA at a longer term follow-up of 3 years. However, larger, suitably powered studies would be beneficial to confirm this.