The RECOVERY trial compared 980nm endovenous laser therapy to the ClosureFAST radiofrequency thermal ablation device in the treatment of incompetent great saphenous veins.
Sixty nine patients were randomised to either laser or radiofrequency ablation. Where both legs required treatment, the patient received the same therapy in each. Eighty seven great saphenous veins were treated in all.
The study looked at short-term outcomes, including quality of life, venous clinical severity scores, and adverse events, during a one month period.
Apparatus were covered with a sheet and protective goggles were worn during each procedure to ensure that patients did not know which treatment they were receiving.
Follow-up was performed with duplex ultrasound at 24-72 hours and at one month, and clinical assessment and quality of life questionnaires at 24-72 hours, one and two weeks, and at one month.
Primary outcomes assessed were: Closure of treated vein within 3cm of saphenofemoral juntion; pain, as assessed by the patient on a ten-point scale; ecchymosis, measured by clinical staff on a five-point scale; and adverse sequelae.
Secondary outcomes included venous clinical severity score and quality of life as determined by the CIVIQ2 questionnaire.
There was 100% vein occlusion and elimination of reflux in both groups, but the ClosureFAST group of 46 patients reported only two adverse events (one case of hyperpigmentation and one of paresthesia), whereas the laser ablation group (41 patients) reported nine.
Patients also reported experiencing less post-procedural pain with radiofrequency treatment and were assessed to have higher venous clinical severity scores in the earlier stages of follow-up.
By one month, however, both groups demonstrated similar outcomes.
These results were presented to the 34th Annual Scientific Meeting of the Society of Interventional Radiology, San Diego, USA, in March 2009, by John Kaufmann of the Dotter Interventional Institute, Portland, USA.
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