Temple University School of Podiatric Medicine Journal Review Club

Editor's note: This post is part of the Temple University School of Podiatric Medicine (TUSPM) journal review club blog series. In each blog post, a TUSPM student will review a journal article relevant to wound management and related topics and provide their evaluation of the clinical research therein.

Article Title: A Randomized Trial of Early Endovenous Ablation in Venous Ulceration

Authors: Gohel, Manjit; Heatly, Francine; Liu, Xinxue; Bradbury, Andrew; Bulbulia, Richard; Cullum, Nicky; Epstein, David; Nyamekye, Isaac; Poskitt, Keith; Renton, Sophie; Warwick, Jane; Davies, Alun

Journal: N Engl J Med

Reviewed by: Kyle Miller, Class of 2020, Temple University School of Podiatric Medicine

Introduction

Venous hypertension with associated venous reflux is the most common cause of leg ulceration. It is well established that compression therapy improves venous ulcer healing and is the standard of care around the country for such wounds. Venous incompetence can be present in both superficial and deep venous systems, leading to increased swelling in the lower extremity because of the faulty valves. This venous reflux can be mitigated in the superficial venous system by implementing minimally invasive venous ablation therapies.

The ESCHAR study performed in 2004 found that venous ablation therapy used concurrently with compression lowered rates of recurrence but not with higher rates of ulcer healing. However, observational studies have reported higher rates of ulcer healing in patients receiving the procedure. For this reason, the authors of this current study looked further into ulcer healing rate by conducting the Early Venous Reflux Ablation (EVRA) trial to determine whether early minimally invasive venous ablation therapy as an adjunct to compression therapy was more effective at healing ulcers more quickly than compression therapy alone.

Methods

The trial itself was a multicenter, randomized controlled trial funded by the National Institutes of Health. The study ran from October 2013 to September 2016 at 20 participating vascular surgery departments across the United Kingdom. A total of 450 patients were randomized at a 1:1 ratio to receive compression therapy and undergo early venous reflux ablation or to receive compression therapy alone with consideration of venous reflux ablation deferred. Compression therapy was provided by trained nursing teams according to the local standard of care. Patients in the early intervention group were generally underwent ablation within two weeks of their randomization. Ultrasound imaging was performed six weeks after the procedure to confirm ablation of the veins. In the deferred intervention group, ablation was considered after the ulcer had healed or at least six months after randomization if the ulcer had not healed. All patients were followed up for 12 months. Venous Clinical Severity Score assessment, Aberdeen Varicose Vein Questionnaire, and two generic quality of life assessments were performed at randomization, at six weeks, six months, and 12 months following randomization.

Results

The primary outcome measure in this study was time to ulcer healing from the date of randomization through the 12-month follow-up period. In the early intervention group, time to healing was 56 days versus 82 days in the deferred treatment group. Recurrence in the early intervention group was 11.4%, and in the deferred group it was 16.5%. The median ulcer-free time during the 12-month follow-up period was 306 days in the early intervention group and 278 days in the deferred intervention group. Ultimately, 75% of the patients in the deferred intervention group underwent an endovenous intervention within one year after randomization.

Discussion

It was found that faster healing rates of venous ulcers can be achieved with a combination of early venous reflux ablation and compression as compared with compression alone. It should be noted that this benefit was found even with high-quality compression therapy, which may explain the similar healing rates at 12 months in the control and treatment groups. This level of compliance cannot always be expected outside of a randomized controlled trial. This study shows that even in the presence of deep venous reflux, superficial venous ablation can be beneficial for patients with venous ulceration. It was concluded that early endovenous ablation utilized concurrently with compression was associated with a shorter time to healing of venous leg ulcers than compression therapy alone.

About the Author

Kyle Miller is a third-year student at Temple University School of Podiatric Medicine (TUSPM). He graduated from the University of Colorado-Boulder in 2016 with a bachelor of arts in biochemistry. At TUSPM, he has become involved with a multitude of clubs and currently holds officer positions in the American Public Health Association Club and the Sports Medicine Club. Kyle is interested in reconstructive surgery, limb salvage, and diabetic wound care. Dr. James McGuire is the director of the Leonard S. Abrams Center for Advanced Wound Healing and an associate professor of the Department of Podiatric Medicine and Orthopedics at the Temple University School of Podiatric Medicine in Philadelphia.