Comparison of Laser, Surgery, and Foam Sclerotherapy - CLASS

Sep 17, 2019
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
National Institute for Health Research
Original Posted Date:
09/17/2019
References

Contribution To Literature:

The CLASS trial showed that either laser ablation or surgery was superior to foam sclerotherapy for treatment of symptomatic primary varicose veins.

Description:

The goal of the trial was to evaluate laser ablation versus foam sclerotherapy versus surgery among patients with primary symptomatic varicose veins.

Study Design

  • Randomized
  • Parallel

Patients with symptomatic primary varicose veins were randomized to laser ablation (n = 212) versus foam sclerotherapy (n = 292) versus surgery (n = 294).

  • Total number of enrollees: 798
  • Duration of follow-up: 5 years
  • Mean patient age: 50 years
  • Percentage female: 57%

Inclusion criteria:

  • Patients ≥18 years of age with primary symptomatic varicose veins >3 mm in diameter
  • Reflux of the great saphenous or small saphenous vein of >1 second

Exclusion criteria:

  • Deep vein thrombosis
  • Superficial vein thrombosis

Principal Findings:

Disease-specific quality of life at baseline was 17.7 in the laser ablation group versus 17.3 in the foam sclerotherapy group versus 18.3 in the surgery group. Lower score indicates a better quality of life. Quality of life at 5 years was 8.6 in the laser ablation group versus 11.0 in the foam sclerotherapy group versus 8.7 in the surgery group. Aberdeen Varicose Vein Questionnaire; lower score indicates a better quality of life. Difference between laser ablation and foam sclerotherapy (-2.86, p < 0.001). Difference between surgery and foam sclerotherapy (-2.60, p < 0.001).

For secondary outcomes: Laser therapy had a 77% probability of being cost-effective.

Interpretation:

Among patients with symptomatic primary varicose veins, either laser ablation or surgery was associated with a greater improvement in disease-specific quality of life compared with foam sclerotherapy. Laser therapy (performed under local anesthesia) had a 77% probability of being cost-effective.

References:

Brittenden J, Cooper D, Dimitrova M, et al. Five-Year Outcomes of a Randomized Trial of Treatments for Varicose Veins. N Engl J Med 2019;381:912-22.

Keywords: Anesthesia, Local, Laser Therapy, Quality of Life, Saphenous Vein, Sclerotherapy, Thrombosis, Treatment Outcome, Varicose Veins, Vascular Diseases, Vascular Surgical Procedures, Venous Thrombosis


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