Multicentre Randomised Controlled Trial of Compression Therapy Following Endothermal Ablation (COMETA)

Background

Varicose veins are common and are known to affect approximately one third of the population. Chronic venous disease (CVD) has been shown to have a negative impact on the quality of life of patients and treatment of varicose veins has been demonstrated to lead to improvement in the quality of life of patients. Over the past decade, new endovenous techniques have been introduced and these are felt to be cost-effective, especially, when performed in an outpatient or 'office-based' setting.

There is currently uncertainty about the use of compression stockings following treatment of varicose veins. In their consensus statement in 2008, the International Union of Phlebology (IUP) stated that there is good evidence for using compression in certain clinical indications. These include the management of telangiectasia after sclerotherapy, varicose veins in pregnancy, prevention of thromboembolism and healing of ulcers. However, a few questions remain unanswered, such as the length of treatment and level of compression to be used6. The Society for Vascular Surgery and the American Venous Forum recommend using compression stockings post-operatively for 1 week to prevent haematoma formation, pain and swelling. The 2013 NICE Guidelines on Varicose Veins in the Legs recommended the use of compression hosiery for no more than 7 days after interventional treatment for varicose veins. However, due to current uncertainty of compression bandaging or hosiery compared to no compression after interventional treatment for varicose veins, the NICE Guideline Development Group have advocated further research to evaluate the clinical and cost effectiveness of this post-procedure intervention. The guidelines also suggested looking into the length of time compression bandaging should be worn if it shown to be beneficial.

Several researchers have looked into the practice of using compression after venous ablation. In a survey of the management of varicose veins by the members of the Vascular Society of Great Britain and Ireland, Edwards et al. found that the majority of surgeons used bandages post-operatively, with 49% using elastic bandages. The literature on the use of compression stockings following treatment of varicose vein is limited.

Between December 2006 and February 2008, Bakker and colleagues conducted a prospective randomised controlled trial on the use of compression stockings after endovenous laser ablation of the great saphenous vein. One hundred and nine patients were approached with 93 finally randomised to use compression stockings for 2 days (Group A) and 7 days (Group B), respectively. All patients were followed up for 3 months post-treatment and the visual analogue scale (VAS) for pain was recorded at 48 hours, 1 week and 6 weeks. A physical examination and quality of life was assessed at 1 week and 6 weeks. Occlusion rate at the 3 month point was also evaluated. Physical function and vitality was shown to be significantly better in group B at 1 week follow-up, but there was no statistically significant difference at 6 weeks. At 1 week, it was also noted that the VAS score in group B (VAS score 2.0 ± 1.1) was significantly lower than in patients wearing compression stockings for 48 hours (VAS score 3.7 ± 2.1) (p≤0.001)10. No significant difference was, however, observed at 6 weeks post-procedure. Limitations of the study include the high drop out of the trial (40 out of the initial 109 approached) and the absence of any phlebectomies or sclerotherapy in the patients.