Five-Year Results of a Randomised Clinical Trial Comparing Concomitant and Sequential Phlebectomy Following Endovenous Laser Ablation.

Abstract

Concomitant ambulatory phlebectomy with endovenous laser ablation (EVLA) for great saphenous vein (GSV) incompetence has been shown to reduce secondary procedures and improve quality of life (QoL) when compared with EVLA alone at 1 year. This study aims to assess the 5-year outcomes of EVLA with concomitant or sequential ambulatory phlebectomy. Patients undergoing EVLA for primary sapheno-femoral junction incompetence with GSV reflux were randomized to receive EVLA alone (EVLA) or EVLA with concomitant phlebectomies (EVLA-AP). EVLA was performed as a day-case procedure under tumescent anesthesia and duplex ultrasound. Follow-up assessments were performed at 1, 6, 12, 52, 104, and 260 weeks. Outcome measures were: secondary procedures; clinical outcomes (recurrence, CEAP, VCSS), duplex GSV reflux; and disease-specific QoL using the Aberdeen Varicose Vein Questionnaire (AVVQ). Fifty patients were equally randomised to receive EVLA or EVLA-AP. One patient withdrew from the EVLA group. EVLA (n = 24; 20 female, 4 male; mean age, 52.5 ± 15.6 years; median VCSS (interquartile range [IQR]), 4 (2-5); median CEAP (IQR), 2 (2-2); EVLA-AP (n = 25; 8 male, 17 female; mean age, 51.1 ± 14.3 years; median VCSS (IQR), 4 (2.25-5); median CEAP (IQR), 2 (2-3.75). All patients successfully underwent their allocated procedure. Follow-up at 5 years for EVLT-AP was 84% (n = 21) and for EVLT was 75% (n = 18). There was no significant difference after 1 year in the requirement for secondary procedures (EVLA, 7 vs EVLA-AP, 5 secondary procedures; P = .520). Intragroup analysis demonstrated significant clinical improvement in both groups over the 5 years; however, there was no significant intergroup differences in clinical recurrence rates (P = .725), CEAP grades (P = .661), VCSS (P = .581), or AVVQ (P = .835). Five-year follow-up demonstrates that the initial benefits of performing concomitant ambulatory phlebectomy are not sustained into the long term. There is no significant difference between clinical or QoL outcomes. This evidence may suggest that phlebectomies can be performed as per patient and surgeon preference.