Management venous ulcers: Lessons learnt from ESCAR and EVRA studies

Konstantinos Spanos, MD, MSc, PhD

Vascular Surgeon, Vascular Surgery, Department, University Hospital of Larissa, Larissa, Greece

Disclosures

❑ I have the following potential conflicts of interest to report:

❑ Receipt of grants/research support

❑ Receipt of honoraria and travel support

❑ Participation in a company sponsored speakers‘ bureau

❑ Employment in industry

❑ Shareholder in a healthcare company

❑Owner of a healthcare company

❑ I do not have any potential conflict of interest

Disclosures❑ I have the following potential conflicts of interest to report:❑ Receipt of grants/research support

❑ Receipt of honoraria and travel support

❑ Participation in a company sponsored speakers‘ bureau

❑ Employment in industry

❑ Shareholder in a healthcare company

❑Owner of a healthcare company

❑ I do not have any potential conflict of interest

Egyptian medical papyrus of herbal knowledge dating to circa 1550 BC

Hippocrates (460 – c. 370 BC)

West. Prov Med J Retrosp Med Sci. 1842 Sep 17;4(103):475.

A clinical problem for 200 years

Trials have started 50 years ago…

Let us meet the two trials…..

The aim: to assess healing and recurrence rates after treatment with compression with orwithout surgery in people with leg ulceration

Methods:➢ Duplex imaging of ulcerated or recently healed legs

➢ Randomly allocated either compression treatment alone or in combination with superficial venous surgery

➢ Compression consisted of multilayer compression bandaging every week until healing then class 2 below-knee stockings

Primary endpoints were

❑ 24-week healing rates

❑ 12-month recurrence rates

Outcomes….

Outcomes….

Ulcer healing at 24 weeks is not enhanced by superficial venous surgery

(possibly because the haemodynamic effect of conservative interventions are as great as the combination of superficial venous surgery plus compression)

Superficial venous surgery significantly reduced 12-month ulcer recurrence rate in limbs with chronic venous ulceration

The effect of surgery was significant in legs with isolated superficial venous reflux and with mixed superficial and segmental deep reflux

85% of patients with chronic venous ulceration would benefit from surgery and all should undergo venous duplex imaging with this in mind

What we have learnt…..

Aim: to evaluate the role of early endovenous treatment of superficial venous reflux as an adjunct to compression therapy in patients with venous leg ulcers

Eligibilty:➢ 18 years of age ➢ an open venous leg ulcer that had been present for a period of between 6 weeks and 6 months➢ ABPI > 0.8 or higher➢ Primary or recurrent superficial venous reflux that was deemed by the treating clinician to be clinically

significant

Compression therapy was administered by trained community and hospital-based nursing teams according to the local standard of care Multilayer elastic compression (two to four layers), short-stretch compression, and compression hosiery were all deemed to be acceptable

Superficial venous reflux to be ablated within 2 weeks after randomization.Endovenous laser or radiofrequency ablation, ultrasound-guided foam sclerotherapy, or nonthermal, nontumescent methods of treatment (such as cyanoacrylate glue or mechanochemical ablation) were performed either alone or in combination

The primary outcome measure was the time to ulcer healing from the date of randomization through 12 months

The secondary outcome measures were the rate of ulcer healing at 24 weeks, the rate of ulcer recurrence, the length of time free from ulcers (ulcer-free time) during the first year after randomization, and patient-reported health-related quality of life

Methods….

In a post hoc analysis:

❖ Ulcer healing at 12 weeks were 63.5% in the early intervention group and 51.6% in the deferred-intervention group

❖ Within 1 year ulcer healed 93.8% in the early intervention group and 85.8% in the deferred-intervention group

❖ The between-group difference in healing rates at 1 year was 8.0% points

Outcomes….

❑ Within 1 year the rate of ulcer recurrence was 11.4% in the early-intervention group and 16.5% in the deferred-intervention group

❑ The median ulcer-free time during the 1-year follow-up was 306 daysin the early-intervention group and 278 days in the deferred-intervention group (P = 0.002)

Outcomes….

Outcomes….

What we have learnt…..

‘Recognise that the majority of patients with symptomatic superficial venous reflux are best treated by endovenous methods rather than conventional surgery’

‘Strictly speaking, this change in practice has not been evidenced based and the “belief” among vascular specialists that this was the correct approach has clearly not been enough to convince many community practitioners to refer leg ulcer patients’

ESCHAR provided “level 1” evidence that surgically ablating superficial venous reflux reduces ulcer recurrence rates

EVRA now provides clear evidence that early endovenous ablation acceleratesulcer healing and reduces recurrence, at least out to 12 months

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