Ablation, Surgery Edge Sclerotherapy for Varicose Veins

Diana Phillips

September 04, 2019

Laser ablation and surgery for varicose veins similarly improve patients' quality of life, whereas foam sclerotherapy has less of an effect, a randomized trial shows.

In addition, of the three interventions, laser ablation appeared to be the most cost- effective, Julie Brittenden, MD, of the Institute of Cardiovascular Research at the University of Glasgow, United Kingdom, and colleagues report in an article published online today in the New England Journal of Medicine.

To evaluate the quality of life and cost-effectiveness associated with treatment for varicose veins, the researchers compared the interventions in a large, multicenter, randomized trial, called the Comparison of Laser, Surgery, and Foam Sclerotherapy (CLASS) trial.

In total, 798 patients from 11 centers in the United Kingdom were randomly assigned to receive either foam scelerotherapy, laser ablation, or surgery for treatment of primary symptomatic varicose veins. Inclusion criteria were having varicose veins greater than 3 mm in diameter in one or both legs and reflux of the great saphenous or small saphenous veins of more than 1 second, as measured by duplex ultrasonography.

Five years after the start of the trial, 595 patients completed the Aberdeen Varicose Vein Questionnaire (AVVQ), the EuroQol EQ-5D questionnaire, and the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) for the primary outcome analysis, which included 162 patients in the laser ablation group, 219 in the foam sclerotherapy group, and 214 in the surgery group.

Patients in all three groups showed improvement from baseline in the four primary quality-of-life outcome measures at 5 years. However, the AVVQ scores indicated better quality of life (lower scores) for the patients in the laser ablation and surgery groups than for those in the foam sclerotherapy group. The respective effect sizes for laser ablation and surgery compared with foam sclerotherapy were −2.86 (95% confidence interval [CI], −4.49 to −1.22; P < .001) and −2.60 (95% CI, −3.99 to −1.22; P < .001). For the other quality-of-life measures, there were no significant between-group differences.

Modeling regarding cost-effectiveness favored laser ablation; results were consistent with the authors' previously reported estimates. They write, "laser ablation performed under a local anesthetic in a treatment-room setting had a 77% probability of being cost-effective up to a willingness-to-pay maximum of £20,000 ($28,433)." The cost-effectiveness of surgery compared with foam sclerotherapy was significantly less certain, they note.

With respect to secondary outcomes, no major between-group differences were observed in SF-36 subscale or EQ-5D visual-analogue scale scores. Most patients in all three groups reported that they would be willing to undergo a repeat procedure and would recommend it to others, the authors state.

At 5 years, varicose vein–free status was reported by 58% of the laser ablation group, 54% of the surgery group, and 47% of the sclerotherapy; 11%, 7%, and 14% of patients in the respective groups reported having undergone further treatment. Across the groups, the mean extent of varicose veins, determined on the basis of patient-reported visual-analogue scale score (0 = no varicose veins; 10 = worst imaginable), were 2.6 ± 2.2 with laser ablation, 3.2 ± 2.5 with foam sclerotherapy, and 2.4 ± 2.3 with surgery.

The lesser presence and extent of varicose veins at 5 years in the ablation and surgery groups compared with the sclerotherapy group likely explain the differences in quality of life observed in the study, the authors write. "[D]isease-specific quality of life has previously been shown to be worse among patients who have recurrent disease than among those who do not," they state.

The rates of complete success with respect to truncal-vein ablation at 5 years were 64.0% with laser ablation, 33.3% with foam sclerotherapy, and 75.9% with surgery, which are consistent with previous studies.

Despite limitations related to the study design — specifically, the absence of a placebo or sham procedure and lack of blinding — the findings point to clinically important differences in quality-of-life outcomes that favor laser ablation and surgery over foam sclerotherapy for the treatment of varicose veins and suggest that laser ablation may be the most cost-effective intervention, the authors conclude.

The study was supported by the NIHR Health Technology Assessment Program. The authors have disclosed no relevant financial relationships.

N Engl J Med. Published online September 4, 2019. Abstract

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