A Randomized Trial Comparing Treatments for Varicose Veins

N Engl J Med. 2014 Sep 25;371(13):1218-27. doi: 10.1056/NEJMoa1400781.

Abstract

Background: Ultrasound-guided foam sclerotherapy and endovenous laser ablation are widely used alternatives to surgery for the treatment of varicose veins, but their comparative effectiveness and safety remain uncertain.

Methods: In a randomized trial involving 798 participants with primary varicose veins at 11 centers in the United Kingdom, we compared the outcomes of foam, laser, and surgical treatments. Primary outcomes at 6 months were disease-specific quality of life and generic quality of life, as measured on several scales. Secondary outcomes included complications and measures of clinical success.

Results: After adjustment for baseline scores and other covariates, the mean disease-specific quality of life was slightly worse after treatment with foam than after surgery (P=0.006) but was similar in the laser and surgery groups. There were no significant differences between the surgery group and the foam or the laser group in measures of generic quality of life. The frequency of procedural complications was similar in the foam group (6%) and the surgery group (7%) but was lower in the laser group (1%) than in the surgery group (P<0.001); the frequency of serious adverse events (approximately 3%) was similar among the groups. Measures of clinical success were similar among the groups, but successful ablation of the main trunks of the saphenous vein was less common in the foam group than in the surgery group (P<0.001).

Conclusions: Quality-of-life measures were generally similar among the study groups, with the exception of a slightly worse disease-specific quality of life in the foam group than in the surgery group. All treatments had similar clinical efficacy, but complications were less frequent after laser treatment and ablation rates were lower after foam treatment. (Funded by the Health Technology Assessment Programme of the National Institute for Health Research; Current Controlled Trials number, ISRCTN51995477.).

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Female
  • Follow-Up Studies
  • Humans
  • Intention to Treat Analysis
  • Laser Therapy* / adverse effects
  • Male
  • Middle Aged
  • Outcome Assessment, Health Care
  • Postoperative Complications
  • Quality of Life
  • Saphenous Vein / surgery
  • Sclerotherapy* / adverse effects
  • Sclerotherapy* / methods
  • Severity of Illness Index
  • Ultrasonography, Interventional
  • Varicose Veins / classification
  • Varicose Veins / surgery
  • Varicose Veins / therapy*

Associated data

  • ISRCTN/ISRCTN51995477