Compression therapy in combination with surgical intervention in the treatment of venous leg ulcers and prevention of their recurrence

Introduction

Venous leg ulcers represent a significant burden on the healthcare system and greatly reduce the quality of life of patients. According to European studies, their prevalence in the adult population is around 1% and dramatically increases in people over the age of 80. Chronic venous hypertension, which usually develops due to venous reflux, contributes to the pathophysiology. Compression therapy, along with lifestyle measures and venotonics, is successfully used in both the treatment and prevention of venous ulcers. However, the main drawback of conservative therapy is that it does not address the cause of chronic venous insufficiency - venous reflux.

Some studies have confirmed the beneficial effect of surgical intervention on the superficial venous system on treatment outcomes and prevention of recurrence of venous leg ulcers. According to anatomical studies, most limbs with ulcers have incompetence of vena saphena magna and parva, sometimes in combination with deep venous system reflux. The goal of the ESCHAR study, published in 2007 in the British Medical Journal, was to compare the long-term effectiveness of combining compression therapy and surgical treatment of superficial venous reflux with compression therapy alone in the healing and recurrence of venous leg ulcers.

Methodology and study course

The ESCHAR randomized controlled clinical trial included patients with venous leg ulcers and reflux in the superficial venous system, diagnosed using Doppler ultrasonography. If they had bilateral leg ulcers, the leg with the worse condition was included in the clinical trial, but treatment was the same for both legs. Participants were randomized to either compression therapy or a combination of compression therapy and surgical intervention.

The first phase of compression therapy involved applying a multilayer compression bandage aiming to achieve a pressure of 40 mmHg at the ankle and 17-20 mmHg at the upper calf. To prevent the recurrence of healed ulcers, patients were prescribed compression stockings of the 2nd compression class. The surgical procedure consisted, in cases of reflux in the area of the saphenofemoral junction or vena saphena magna, of junction interruption, vein stripping, and calf varix avulsion. In the case of reflux in the vena saphena parva, the procedure involved the interruption of the saphenopopliteal junction and calf varix avulsion. For patients contraindicated for general anesthesia, only junction interruptions were performed under local anesthesia.

The primary endpoints were healing of the venous leg ulcer and the occurrence of any recurrence. The secondary endpoint was ulcer-free time. A healed venous leg ulcer was defined as complete re-epithelialization, and any disruption of the epithelial integrity in the leg area was considered a recurrence. Ulcer-free time was evaluated over a 3-year period from study entry.

Results 

A total of 500 patients were enrolled, with 258 randomized to compression therapy alone and 242 to combined therapy. During the study, 54 patients were lost to follow-up (27 in each group), another 47 refused the surgical procedure, and 3 in the conservative group requested surgery. The groups were matched for age, gender, ulcer chronicity, and ulcer size. Overall mortality after 3 years of follow-up was 17% and did not significantly differ between groups, with no deaths occurring within 30 days of surgery or directly related to the surgical procedure.

In total, 81% of patients randomized to surgery underwent the procedure, most commonly involving the vena saphena magna (72%, n = 141), less frequently vena saphena parva (14%; n = 27), or combined (11%; n = 21). Surgical complications occurred in 8 patients, with 2 requiring temporary hospitalization.

The proportion of patients with healed venous leg ulcers after 3 years was 89% in the compression-only group and 93% in the combined treatment group, a statistically insignificant difference (p = 0.737).

There were 122 cases of recurrence in the study (81 in the compression-only group and 41 in the combined treatment group). The recurrence rate of venous leg ulcers after 4 years of follow-up was 56% in the compression-only group and 31% in the combined treatment group (p < 0.01), indicating a statistically significant benefit of adding surgical removal of reflux to compression therapy. In patients with isolated superficial venous system reflux, the recurrence rate of venous leg ulcers over 4 years was 51% with compression alone and 27% with combined treatment (p < 0.01). Similarly, for combined reflux in the superficial and segmental reflux in the deep veins, recurrence rates were 24% and 52% respectively (p = 0.044). For patients with complete deep system reflux along with superficial vein reflux, there was no statistically significant difference in venous leg ulcer recurrence between the therapeutic groups: 24% vs. 46% (p = 0.23).

Ulcer-free time was significantly longer in patients with combined therapy compared to those with compression alone after 3 years of follow-up, both in absolute terms (100 vs. 85 weeks; p = 0.013) and as a proportion of ulcer-free time during 3 years (78% vs. 71%; p = 0.007). 

Conclusion

The cited long-term clinical study concluded that combining compression therapy with surgical treatment of superficial venous reflux does not increase the probability of healing venous leg ulcers but significantly reduces the risk of recurrence. The longer ulcer-free time during the 3-year follow-up also suggests faster ulcer healing when surgical treatment is added to compression therapy.

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Source: Gohel M. S., Barwell J. R., Taylor M. et al. Long term results of compression therapy alone versus compression plus surgery in chronic venous ulceration (ESCHAR): randomized controlled trial. BMJ 2007; 335 (7610): 83, doi: 10.1136/bmj.39216.542442.BE.