Background: Venous ulceration is a common and costly health-care issue worldwide, with poor healing rates greatly affecting patient quality of life. Compression bandaging has been shown to improve healing rates and reduce recurrence, but does not address the underlying cause, which is often superficial venous reflux. Surgical correction of the reflux reduces ulcer recurrence; however, the effect of early endovenous ablation of superficial venous reflux on ulcer healing is unclear.
Objectives: To determine the clinical effectiveness and cost-effectiveness of compression therapy with early endovenous ablation of superficial venous reflux compared with compression therapy with deferred endovenous ablation in patients with venous ulceration.
Design: A pragmatic, two-arm, multicentre, parallel-group, open randomised controlled trial with a health economic evaluation.
Setting: Secondary care vascular centres in England.
Participants: Patients aged ≥ 18 years with a venous leg ulcer of between 6 weeks' and 6 months' duration and an ankle-brachial pressure index of ≥ 0.8 who could tolerate compression and were deemed suitable for endovenous ablation of superficial venous reflux.
Interventions: Participants were randomised 1 : 1 to either early ablation (compression therapy and superficial endovenous ablation within 2 weeks of randomisation) or deferred ablation (compression therapy followed by endovenous ablation once the ulcer had healed).
Main outcome measures: The primary outcome measure was time from randomisation to ulcer healing, confirmed by blinded assessment. Secondary outcomes included 24-week ulcer healing rates, ulcer-free time, clinical success (in addition to quality of life), costs and quality-adjusted life-years (QALYs). All analyses were performed on an intention-to-treat basis.
Results: A total of 450 participants were recruited (224 to early and 226 to deferred superficial endovenous ablation). Baseline characteristics were similar between the two groups. Time to ulcer healing was shorter in participants randomised to early superficial endovenous ablation than in those randomised to deferred ablation [hazard ratio 1.38, 95% confidence interval (CI) 1.13 to 1.68; p = 0.001]. Median time to ulcer healing was 56 (95% CI 49 to 66) days in the early ablation group and 82 (95% CI 69 to 92) days in the deferred ablation group. The ulcer healing rate at 24 weeks was 85.6% in the early ablation group, compared with 76.3% in the deferred ablation group. Median ulcer-free time was 306 [interquartile range (IQR) 240-328] days in the early ablation group and 278 (IQR 175-324) days in the deferred endovenous ablation group (p = 0.002). The most common complications of superficial endovenous ablation were pain and deep-vein thrombosis. Differences in repeated measures of Aberdeen Varicose Vein Questionnaire scores (p < 0.001), EuroQol-5 Dimensions index values (p = 0.03) and Short Form questionnaire-36 items body pain (p = 0.05) over the follow-up period were observed, in favour of early ablation. The mean difference in total costs between the early ablation and deferred ablation groups was £163 [standard error (SE) £318; p = 0.607]; however, there was a substantial and statistically significant gain in QALY over 1 year [mean difference between groups 0.041 (SE 0.017) QALYs; p = 0.017]. The incremental cost-effectiveness ratio of early ablation at 1 year was £3976 per QALY, with a high probability (89%) of being more cost-effective than deferred ablation at conventional UK decision-making thresholds (currently £20,000 per QALY). Sensitivity analyses using alternative statistical models give qualitatively similar results.
Limitations: Only 7% of screened patients were recruited, treatment regimens varied significantly and technical success was assessed only in the early ablation group.
Conclusions: Early endovenous ablation of superficial venous reflux, in addition to compression therapy and wound dressings, reduces the time to healing of venous leg ulcers, increases ulcer-free time and is highly likely to be cost-effective.
Future work: Longer-term follow-up is ongoing and will determine if early ablation will affect recurrence rates in the medium and long term.
Trial registration: Current Controlled Trials ISRCTN02335796.
Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 24. See the NIHR Journals Library website for further project information.
Keywords: COMPRESSION THERAPY; ENDOVENOUS ABLATION; LEG ULCER; VENOUS HYPERTENSION; VENOUS ULCER.
Venous leg ulcers are open wounds occurring on the legs of patients with venous disease. They are common, painful and distressing and reduce patient quality of life. Leg ulcers often result from valves in the leg veins not working properly. The valves normally force blood back up towards the heart; however, blood can flow backwards (reflux) when valves do not work properly, and this can cause swelling and ulceration. Compression therapy (wrapping bandages around the legs) has been shown to help ulcers heal, but it does not treat the underlying reflux problem with the veins. Newer, less invasive, techniques (known as endovenous ablation) have taken over from surgery to correct venous reflux and are more acceptable to patients as they can be performed quickly under local anaesthetic. The aim of the trial was to find out if treating patients with leg ulcers by early endovenous ablation (within 2 weeks) and standard compression therapy can increase ulcer healing compared with standard compression therapy and delayed endovenous ablation once the ulcer has healed. In total, 450 people agreed to take part in this study and were treated in 20 hospitals across England. Participants were randomly allocated to either early or delayed endovenous ablation and followed up for 12 months. The trial found that treating the veins early resulted in quicker ulcer healing than delaying treatment until the ulcer had healed. The trial also showed that participants had more time without an ulcer if the treatment was performed early rather than after ulcer healing. No safety issues with early intervention were identified. There is some evidence that quality of life was better in the early treatment group and that people in this group had less body pain. Treating ulcers early appears likely to be more cost-effective (i.e. a better use of NHS resources) than delayed treatment. Future work will focus on collecting longer-term follow-up data to find out if early endovenous ablation also reduces the chances of the ulcer coming back.