A Randomised Controlled Trial Comparing Three Different Radiofrequency Technologies: Short-Term Results of the 3-RF Trial

Objective To date there has been no comparison of outcomes of endovenous radiofrequency (RF) devices. The 3-RF trial is the first randomised controlled trial of three commercially available RF ablation technologies. Methods Patients were recruited [182/302 patients with great saphenous vein (GSV) incompetence] into a prospective double blind randomised trial of Venefit, radiofrequency induced thermal therapy (RFITT), and endovenous radiofrequency (EVRF). The primary outcome measure was GSV closure (total/partial/failed) at six months. Secondary outcome measures included ablation times, complications, pain scores, analgesia requirements, and quality of life (QoL) scores to 12 months. Results Patients treated [180: Venefit (57), RFITT (64), EVRF (59)] were matched for age, sex, and vein characteristics. At six months, complete GSV closure was significantly better after Venefit and RFITT treatment (100% and 98%, respectively) compared with EVRF treatment (79%, p  Conclusion Compared with Venefit and RFITT, EVRF was associated with significant failure of truncal ablation at six months; however, clinical outcomes did not differ significantly at 12 months. clinicaltrials.gov identifier: NCT02441881 , NHS Health Research Authority (Hampstead Research Ethics Committee) number: 14/LO/1232.