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).