Laser ablation and surgery for varicose veins led to similar quality of life at 5 years, and both were superior to foam sclerotherapy, results from a randomized trial showed.
Patient-reported outcomes in a varicose vein-specific questionnaire showed a two- to three-point improvement in scores for patients who had laser treatment or surgery versus sclerotherapy (P<0.001). Scores did not differ significantly between laser ablation and surgery.
In addition, noted Julie Brittenden, MD, of the University of Glasgow in Scotland, and co-authors, a cost-effectiveness analysis favored laser ablation over surgery and sclerotherapy.
The results, published online in the New England Journal of Medicine, showed that “in all three groups, quality of life 5 years after treatment was improved from baseline,” the team concluded. “However, there were clinically important between-group differences in disease-specific quality of life that favored laser ablation and surgery over foam sclerotherapy. Laser ablation was similar to surgery with respect to quality of life and of the three treatments had the highest chance of being cost-effective.”
The trial held few surprises for Tina Alster, MD, director of the Washington Institute of Dermatologic Laser Surgery in Washington, D.C.
“Laser and foam sclerotherapy have been part of the dermatology arsenal for decades,” she told MedPage Today. “Previous studies have show similar efficacy with laser and foam, but as far as I know, this is the first randomized trial comparing both of those techniques with surgery. In that respect it’s something of a landmark trial. We haven’t had that kind of data until now.”
“Not too many people still perform the old vein-stripping procedure anymore, primarily for two reasons,” she added. “Less invasive treatment approaches have become more widely available, and earlier diagnosis and treatment occur before the veins become severe.”
As Alster pointed out, less invasive alternatives to surgery have been available for years, but limited data have accumulated for the relative safety and efficacy of laser ablation and sclerotherapy versus surgery. The Comparison of Laser, Surgery, and Foam Sclerotherapy trial compared the three treatment modalities in patients with primary symptomatic varicose veins larger than 3 mm in diameter in one or both legs and reflux of the greater saphenous or small saphenous veins greater than 1 second by duplex ultrasound.
The three treatment approaches were as follows:
- Surgery — Proximal ligation and stripping (great saphenous vein only) and concurrent phlebectomies
- Sclerotherapy — Foam consisted of sodium tetradecyl sulfate mixed with air
- Laser — Ablation of the truncal saphenous veins, followed by sclerotherapy for residual varicosities at 6 weeks (if required)
Investigators at 11 vascular surgery centers enrolled 798 patients. The trial had a primary endpoint of disease-specific and generic quality of life, as assessed by multiple scales. As previously reported, the 6-month results showed similar outcomes for patients treated with laser or surgery and slightly worse outcomes for the sclerotherapy group (P=0.006).
For the 5-year follow-up evaluation, investigators contacted all surviving participants and invited them to complete a battery of questionnaires that assessed quality of life, presence of varicose veins, satisfaction with treatment, and any additional treatment they had received. Subsequently, 595 patients participated in the 5-year follow-up, including 467 who attended a clinic visit and 389 who had repeat duplex ultrasonography.
The 5-year results consisted of patient-reported quality of life as assessed by the Aberdeen Varicose Vein Questionnaire (AVVQ) and two generic quality-of-life measures. Additionally, investigators performed a cost-effectiveness analysis to calculate cost per quality-adjusted life-year (QALY) gained with each of the treatment modalities.
The AVVQ has a score range of 0-100, with lower scores representing better quality of life. Mean baseline AVVQ scores were 17-18 for all three treatment groups. At 5 years, the laser group had a mean score of 8.6, followed by surgery at 8.7, and sclerotherapy at 11.0. Scores did not differ significantly among the three treatment groups for any of the three generic quality-of-life measures used to evaluate the patients.
“With regard to patient satisfaction, the majority of participants were willing to repeat the same treatment and to recommend the treatment they had received to a friend,” the authors wrote.
The results showed that 58% of the laser group reported no varicose veins at 5 years, as compared with 54% for the surgery group and 47% for the sclerotherapy group. The difference between laser and sclerotherapy achieved statistical significance (odds ratio 0.59, 95% CI 0.41-0.85). Additionally, 14% of the sclerotherapy group, 11% of the laser group, and 7% of the surgery group had undergone additional treatment at 5 years.
At a willingness-to-pay ratio of about $28,000 per QALY, 77.2% of the cost-effectiveness models favored laser ablation over the other two modalities, the researchers reported. For the comparison of surgery versus sclerotherapy, 54% of the models favored surgery.
The study was supported by the National Institute for Health Research.
The authors reported having no relevant relationships with industry.