Endovenous laser ablation and drug treatment of acute great saphenous vein ascending thrombophlebitis: comparison of three approaches to the treatment of patients

Abstract

Aim. In patients with acute thrombophlebitis of the great saphenous vein and/or large tributaries, compare the effectiveness and safety of 1,5-month fondaparinux sodium therapy and endovenous laser ablation in the area of the saphenofemoral junction in combination with shortterm anticoagulation or without anticoagulant therapy.Material and methods. This prospective, single-center, randomized, open-label clinical trial included 105 patients with acute great saphenous vein thrombophlebitis at a distance of at least 5 cm from the saphenofemoral junction. Thirty-four patients were randomized into the group of endovenous laser ablation in the area of the saphenofemoral junction without the anticoagulant therapy. The group of endovenous laser ablation in combination with 7-day fondaparinux sodium included 35 patients, while the group of 1,5-month treatment with fondaparinux sodium — 36. In all cases, class 2 compression stockings were used for 1,5 months. Clinical manifestations of venous thrombosis and its prevalence according to compression ultrasonography were assessed in the first 45±2 days from the start of treatment.Results. The mean age of patients was 49,1±13,7 years. There were more women (73,3%). The prevalence of risk factors for the occurrence and progression of venous thrombosis was low. Previous episodes of thrombophlebitis were observed in 3 (2,9%) patients. External factors that could provoke venous thrombosis were identified in 21 (20,0%) patients. Thrombosis was located in the great saphenous vein in 97,1% of patients, while large tributaries were involved in 25,7% of cases. The median distance from the proximal thrombus to the saphenofemoral junction was 45,2 cm. Patients randomized to the pharmacotherapy group were significantly older (mean age 49,1±13,7, 45,9±13,3 and 53,8±13,2 years, respectively; p=0,032), had slightly less pain and swelling. In all patients, after endovascular laser obliteration, a stable flow cessation at the intervention site was achieved. There were no cases of progression of venous thrombosis. After 7±2 days, in all groups there was a significant decrease in the proportion of patients with clinical manifestations of venous thrombosis, as well as the severity of persistent clinical manifestations. After 45±2 days, clinical manifestations were observed in a few patients and their severity was minimal. However, in the drug treatment group, a more frequent persistence of edema was noted both after 7±2 days (26,5, 20,0 and 47,7%, respectively; p=0,036) and after 45±2 days, (0, 2,9 and 16,7%, respectively; p=0,01). Hematomas and bruises were exclusive hemorrhagic complications. Hematomas were revealed in groups with endovenous laser ablation only. All hemorrhagic complication were minor according to World Society of Thrombosis and Hemostasis (ISTH) and type 1 according to Academic Research Consortium (BARC) classifications.Conclusion. In outpatients with low risk of recurrence and mainly distal localization of acute thrombophlebitis of the great saphenous vein and/ or large inflows, endovenous laser ablation close to saphenous vein junction without anticoagulation or with 7 days of anticoagulation and medical treatment with 1,5-month anticoagulation had comparable efficacy and invasive treatment was sufficiently safe.