BACKGROUND: A variety of minimally invasive techniques are available for the treatment of varicose great saphenous vein (GSVs). Non-tumescent, non-thermal ablation methods have been developed. This study compared mechanochemical ablation (MOCA), a non-tumescent, non-thermal ablation technique, with two endovenous thermal ablation methods requiring tumescence in an RCT. METHODS:Patients with GSV reflux were randomized to undergo MOCA, or thermal ablation with endovenous laser (EVLA) or radiofrequency (RFA). The primary outcome measure was the occlusion rate of the GSV at 1 year. RESULTS: The study finally included 125 patients, of whom 117 (93·6 per cent) attended 1-year follow-up. At 1 year, the treated part of the GSV was fully occluded in all patients in the EVLA and RFA groups, and in 45 of 55 in the MOCA group (occlusion rates 100, 100 and 82 per cent respectively; P = 0·002). The preoperative GSV diameter was associated with the recanalization rate of the proximal GSV in the MOCA group. At 1 year after treatment, disease-specific life quality was similar in the three groups. CONCLUSION: The GSV occlusion rate 1 year after treatment was significantly higher after EVLA and RFA than after MOCA. Quality of life was similar between interventions. Registration number: NCT03722134 (http://www.clinicaltrials.gov).
RCT Entities:
BACKGROUND: A variety of minimally invasive techniques are available for the treatment of varicose great saphenous vein (GSVs). Non-tumescent, non-thermal ablation methods have been developed. This study compared mechanochemical ablation (MOCA), a non-tumescent, non-thermal ablation technique, with two endovenous thermal ablation methods requiring tumescence in an RCT. METHODS:Patients with GSV reflux were randomized to undergo MOCA, or thermal ablation with endovenous laser (EVLA) or radiofrequency (RFA). The primary outcome measure was the occlusion rate of the GSV at 1 year. RESULTS: The study finally included 125 patients, of whom 117 (93·6 per cent) attended 1-year follow-up. At 1 year, the treated part of the GSV was fully occluded in all patients in the EVLA and RFA groups, and in 45 of 55 in the MOCA group (occlusion rates 100, 100 and 82 per cent respectively; P = 0·002). The preoperative GSV diameter was associated with the recanalization rate of the proximal GSV in the MOCA group. At 1 year after treatment, disease-specific life quality was similar in the three groups. CONCLUSION: The GSV occlusion rate 1 year after treatment was significantly higher after EVLA and RFA than after MOCA. Quality of life was similar between interventions. Registration number: NCT03722134 (http://www.clinicaltrials.gov).