For chronic great saphenous vein insufficiency, endovenous laser ablation is comparably effective and as safe as high ligation with vein stripping, according to a study published online Sept. 19 in the Archives of Dermatology.
In what researchers described as the largest and most powerful randomized clinical trial (RCT) to date comparing an endovenous technique with conventional surgery, the two approaches were "equivalent in terms of the primary objective of clinical recurrence," as well as in almost all of the secondary end points, at 2-year follow-up.
"This major finding is in accordance with those of all of the RCTs published so far comparing EVLT [endovenous laser treatment] and HLS [high ligation with stripping]" of the great saphenous vein, said Dr. Knuth Rass of the department of dermatology, venerology, and allergy, Saarland University Hospital, Homburg, Germany, and his associates.
The investigators reported the 2-year results of the ongoing RELACS (Randomized Study Comparing Endovenous Laser Ablation With Crossectomy and Stripping of the Great Saphenous Vein). The trial enrolled 400 consecutive patients (one treated leg per patient) who were seen at two medical centers in Germany for great saphenous vein insufficiency with saphenofemoral incompetence and reflux at least down to the knee level.
However, 54 subjects dropped out after randomization, mostly because they preferred the treatment to which they were not assigned. So the study analyses were based on the per-protocol population of 185 treated with EVLT and 161 treated with HLS.
The primary end point (the rate of freedom from clinical recurrence) was 84% with EVLT and 77% with HLS, a nonsignificant difference.
Similarly, the recurrence-free rates specifically involving varicose veins originating from the operative site were 97% in both groups, the researchers reported (Arch. Dermatol. 2011 [doi:10.1001/archdermatol.2011.272]).
Also in both groups, the scores on a measure of varicose vein severity declined from baseline to 3 months, declined further from 3-12 months, and remained stable at 12-24 months. Disease-specific quality of life scores improved significantly and to the same degree in both groups, with no differences in subscores on pain, physical well-being, psychological well-being, or social well-being.
There were no significant differences between the two groups in the rate of major complications, which was 1.1% overall. These included one case of GI bleeding in the EVLT group, which was related to the use of low-molecular-weight heparin and oral ibuprofen, and two cases of thrombus propagation into the common femoral vein, also in the EVLT group.
Minor adverse effects were frequent but mild in both groups. "Phlebitic reactions, indurations, dyspigmentations, and pain incidence and intensity were more pronounced in the EVLT group. [But] pain persisted longer after HLS," noted the investigators. Bruising and dysesthesia were the same in both groups.
A "remarkable" 98% of both groups said they were satisfied with treatment and would undergo each procedure again if medically necessary.
The two treatment approaches did differ in the incidence of recurrences at the saphenofemoral junction as detected on duplex ultrasonography. These recurrence-free rates were 82% with EVLT and 99% with HLS. However, this difference had no apparent effect on clinical or functional outcome.
"Currently, it remains speculative as to if, when, and to what extent the duplex-detected refluxes at the saphenofemoral junction evolve to a clinical recurrence. ... Further follow-up to 5 years after treatment is scheduled for this study and will probably provide more evidence on this topic," Dr. Rass and his associates wrote.
No conflicts of interest were reported.