The EVRA Trial: 7 Years Later, Are We Finally Getting Venous Leg Ulcer Treatment Right?

Venous leg ulcers are more than just a medical problem; they're a quality-of-life thief.

But what if we could give patients back their freedom, their mobility, their lives?

The answer may lie in a technique called ULTRASOUND GUIDED FOAM SCLEROTHERAPY.

If you treat venous leg ulcers, you know the struggle.

Imagine a patient whose life is severely impacted by a leg ulcer that is slow to heal, impacting their mobility, causing constant pain, and affecting their mental well-being.

Venous leg ulcers may affect nearly a million people in the UK, and a landmark study published nearly seven years ago in the New England Journal of Medicine offers a game-changing approach.

Nearly every publication since references this pivotal trial: the EVRA trial.

Let's summarise this crucial research, a randomized trial conducted in the United Kingdom, which investigated the effect of early endovenous ablation of superficial venous reflux on venous leg ulcer healing.

450 patients with venous leg ulcers were randomly assigned to two groups: one receiving compression therapy and immediate ablation (endovenous ablation within 2 weeks), and the other receiving compression therapy alone (with delayed ablation considered after 6 months or ulcer healing). The study found that immediate ablation resulted in faster ulcer healing and longer ulcer-free time than delayed ablation.

The EVRA trial was a multicenter, parallel-group, randomized, controlled trial, approved by the South West-Central Bristol Research Ethics Committee and overseen by independent committees. From October 2013 to September 2016, patients with open venous leg ulcers were screened at 20 UK centers. Inclusion criteria included age over 18, ulcer duration between 6 weeks and 6 months, ankle-brachial index of 0.8 or higher, and clinically significant superficial venous reflux. Exclusion criteria included pregnancy, inability to adhere to compression therapy, deep venous occlusive disease, non-venous leg ulcers, and need for skin grafting. Patients were randomized 1:1 to the immediate intervention group (compression therapy and immediate ablation) or the deferred intervention group (compression therapy with deferred consideration of endovenous ablation). The primary outcome was time to ulcer healing, and secondary outcomes included healing rate at 24 weeks, ulcer recurrence, ulcer-free time, and quality of life.

450 patients were randomized, with similar baseline characteristics between groups. Immediate ablation led to shorter time to ulcer healing (hazard ratio 1.38, p=0.001), with a median healing time of 56 days compared to 82 days for delayed ablation. The healing rate at 24 weeks was 85.6% for immediate intervention and 76.3% for deferred intervention. Ulcer recurrence was lower in the immediate intervention group, with a median ulcer-free time of 306 days compared to 278 days for deferred intervention. Pain and deep-vein thrombosis were the most common procedural complications.

The trial demonstrated that immediate endovenous ablation significantly reduced healing time for venous leg ulcers and led to longer ulcer-free periods compared to delayed ablation. This benefit was seen despite high-quality compression therapy in both groups. The study suggests that prompt endovenous intervention can improve outcomes for venous leg ulcers, and that current care pathways should be revised to include early assessment and treatment for superficial venous reflux. Notably, ultrasound-guided foam sclerotherapy was the predominant method used, reflecting its versatility and acceptability as a minimally invasive procedure.

There was no industry sponsorship. The study was supported by a grant from the NIHR and is freely available in the NEJM (no paywall).

So, the headline takeaway is clear: immediate endovenous ablation reduces healing time. Ulcers heal faster.

The provided text does not specify how many patients were treated with endovenous laser and how many were treated by radiofrequency ablation. The two methods are grouped together under the term “Endothermal ablation”. The combined number who underwent endothermal ablation only, in both the immediate and deferred intervention groups, was 71 + 54 = 125. The number who underwent foam sclerotherapy only, in both groups, was 111 + 100 = 211.

Ultrasound-guided foam sclerotherapy was the most frequent intervention by far!

This is important because (as Christopher Pittman, M.D., FAVLS, FACR, FACP (Hon) has frequently stated) only UGFS can be scaled sufficiently to address the huge problem of venous leg ulcers.

Ultrasound-guided foam sclerotherapy stands out due to its relative simplicity, lower cost compared to other endovenous techniques, and ease of administration, making it more readily scalable within healthcare systems facing the challenge of treating large patient populations with venous leg ulcers. This accessibility is crucial for widespread implementation and improved patient outcomes.

The EVRA trial offers compelling evidence for the benefits of early intervention, and the widespread use of foam sclerotherapy highlights its potential to transform venous leg ulcer care.

If you're a healthcare professional treating patients with venous leg ulcers, I encourage you to explore the latest research on Foam Sclerotherapy Experts Group here on Linkedin and consider how it might improve outcomes for your patients.

The EVRA trial has paved the way for a new era in venous leg ulcer management, and it’s time to embrace these advancements to provide the best possible care for our patients.

Why not join me at the British Association of Sclerotherapists Annual Conference in May and together we can share expertise and experience.