Interim results on abolishing reflux alongside a randomized clinical trial on laser ablation with phlebectomies versus foam sclerotherapy

Int Angiol. 2013 Aug;32(4):394-403.

Abstract

Aim: The early results of a randomised clinical trial comparing local anaesthesia endovenous laser ablation (EVLA) with concurrent phlebectomies versus ultrasound-guided foam sclerotherapy (UGFS) into the great saphenous vein (GSV) revealed that laser was more expensive but the results on abolition of reflux were similar. The interim results at 15 month follow-up are reported.

Methods: Evaluations included ultrasound, the venous clinical severity score (VCSS), the Aberdeen varicose vein questionnaire (AVVQ) and the saphenous treatment score (STS). The global absence of reflux defined technical success. Adjuvant sclerotherapy to areas of reflux was administered on patient choice.

Results: Occlusion of the GSV was more effective with EVLA at 42/44 (95.5%) versus 31/46 (67.4%) for UGFS. However both techniques were equally effective at abolishing global venous reflux. The number of legs (N.=100) with total reflux abolition, above-knee, below-knee or combined reflux and loss to follow-up was 18, 6, 12, 8, 6 with EVLA and 20, 8, 11, 7, 4 with UGFS, respectively. The VCSS, AVVQ and STS reduced compared to baseline (P<0.0005), but there was no statistical difference between the groups. The AVVQ remained unchanged between 3-15 months (P=0.601). Also during this time, 19/46(41%) UGFS versus 9/44(20%) EVLA legs received adjuvant treatment (2.1 times increase). However, overall, adjuvant foam was given 4.7 times more frequently in the UGFS patients.

Conclusion: EVLA and UGFS are equally effective at abolishing global venous reflux with overall success of 41% and 43%, respectively. The high reflux rate was not related to deterioration in quality of life indicating that this reflux was largely asymptomatic.

Publication types

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

MeSH terms

  • Adult
  • Aged
  • Anesthesia, Local
  • Chi-Square Distribution
  • England
  • Female
  • Humans
  • Laser Therapy* / adverse effects
  • Logistic Models
  • Male
  • Middle Aged
  • Multivariate Analysis
  • Predictive Value of Tests
  • Prospective Studies
  • Quality of Life
  • Saphenous Vein / diagnostic imaging
  • Saphenous Vein / physiopathology
  • Saphenous Vein / surgery*
  • Sclerosing Solutions / administration & dosage*
  • Sclerosing Solutions / adverse effects
  • Sclerotherapy* / adverse effects
  • Severity of Illness Index
  • Sodium Tetradecyl Sulfate / administration & dosage*
  • Sodium Tetradecyl Sulfate / adverse effects
  • Surveys and Questionnaires
  • Time Factors
  • Treatment Outcome
  • Ultrasonography, Doppler, Duplex
  • Ultrasonography, Interventional
  • Varicose Veins / diagnosis
  • Varicose Veins / physiopathology
  • Varicose Veins / therapy*
  • Venous Insufficiency / diagnosis
  • Venous Insufficiency / physiopathology
  • Venous Insufficiency / therapy*
  • Young Adult

Substances

  • Sclerosing Solutions
  • Sodium Tetradecyl Sulfate

Associated data

  • ISRCTN/ISRCTN03080206