Randomized clinical trial of 940-versus 1470-nm endovenous laser ablation for great saphenous vein incompetence

Background: The independent effect of wavelength used for endovenous laser ablation (EVLA) on patient-reported outcomes, health-related quality of life (HRQoL), treatment success and complications has not yet been established in a randomized clinical trial. The aim was to compare two different wavelengths, with identical energy level and laser fibres, in patients undergoing EVLA. Methods: Patients with great saphenous vein incompetence were randomized to receive 940- or 1470-nm EVLA. The primary outcome was pain at 1 week. Secondary outcomes were: patient satisfaction, duration of analgesia use and time without normal activities assessed at 1 week; HRQoL after 12 weeks; treatment success after 12 and 52 weeks; change in Venous Clinical Severity Score (VCSS) after 12 weeks; and adverse events at 1 and 12 weeks. Results: A total of 142 legs were randomized (940-nm EVLA, 70; 1470-nm EVLA, 72). Patients in the 1470-nm laser group reported significantly less pain on a visual analogue scale than those in the 940-nm laser group: median (i.q.r.) score 3 (2-7) versus 6 (3-8) (P = 0.004). Duration of analgesia use was significantly shorter after 1470-nm EVLA: median (i.q.r.) 1 (0-3) versus 2 (0-5) days (P = 0.037). HRQoL and VCSS improved equally in both groups. There was no difference in treatment success rates. Complications were comparable in both groups, except for more superficial vein thrombosis 1 week after 1470-nm EVLA. Conclusion: EVLA using a 1470-nm wavelength fibre was associated with improved postoperative pain and a reduction in analgesia use in the first week after surgery compared with use of a 940-nm fibre. Treatment success and adverse event rates were similar. Registration number: NCT01637181 (http://www.clinicaltrials.gov).