Surgery or lasers preferred to foam sclerotherapy for varicose veins

Référence

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(10): 912-22.

Sommaire

The researchers identified 798 adults with primary symptomatic varicose veins at least 3 mm in diameter in at least one leg, plus evidence of reflux of the saphenous veins by more than 1 second by duplex ultrasound. Patients with deep or superficial thrombosis were excluded. If a participant had more than one involved leg, the worse leg was the "study leg". They were randomized to one of three treatment options: foam sclerotherapy, laser ablation (followed by foam sclerotherapy if needed), and surgery. Of 11 centers, 3 only offered foam sclerotherapy or surgery leading to an imbalance in the number in each group, with only 212 in the laser ablation group compared with 292 to 294 in the other groups. Follow-up with the primary outcome questionnaire was 87% to 92% at 6 weeks, 82% to 88% at 6 months, and 73% to 76% at 5 years. There were more early withdrawals in the surgery group. Data from case notes were available for 96% of patients. Groups were balanced, with a mean age of 49 years, 57% women, and about three-quarters having involvement in only a single leg. Analysis was by intention-to-treat. After 5 years, the Aberdeen Varicose Vein Questionnaire score had decreased more in the laser ablation and surgery groups than in the foam sclerotheray group. The effect sizes were clinically as well as statistically significant. A cost-effectiveness analysis favored laser ablation over the other two approaches.