Stripping of the great saphenous vein under micronized purified flavonoid fraction (MPFF) protection (results of the Russian multicenter controlled trial DEFANCE)

Abstract

This paper presents the results of the DEFANCE study (Daflon 500 mg* -assEssment of eFficacy ANd safety for Combined phlEbectomy study). The aim of the study was to compare the intensity of postoperative pain, the size of postoperative hematoma, and quality-of-life score between two groups of patients: • a Daflon 500 mg group: patients who underwent stripping of the great saphenous vein (GSV) and were treated with Daflon 500 mg 14 days before and 30 days after surgery • a control group: patients who underwent stripping of the GSV and were not treated with Daflon 500 mg The study enrolled 245 patients with varicose vein disease who underwent unilateral stripping of the GSV in combination with stab avulsion. The treatment group (n=200) received micronized purified flavonoid fraction (MPFF, Daflon 500 mg, 1000 mg/day) for 2 weeks before and 30 days after the procedure; the control group (n=45) did not receive Daflon 500 mg in the pre- and postoperative periods. Pain severity was assessed by means of a 10-point visual analog scale (VAS) and an original 12-point scale was used to evaluate subcutaneous hematomas in the medial aspect of the thigh (zone of the GSV stripping). Subjective symptoms and quality of life were evaluated 7, 14, and 30 days after the procedure. Subjective symptoms and the area of subcutaneous hematomas were significantly lower in the Daflon 500 mg group than in the control group: 7 days after the procedure, VAS scores were 2.9 and 3.5, respectively and hematoma area 3.4 and 4.6 points, respectively. The same trend was observed for limb heaviness and fatigue, evidencing the better exercise and orthostatic tolerance of patients of the Daflon 500 mg group in the early postoperative period. Quality of life assessment by means of CIVIQ, a chronic venous insufficiency questionnaire, failed to reveal statistically significant differences between the Daflon 500 mg and control groups in 4-week postoperative follow-up. Micronized purified flavonoid fraction (Detralex, Daflon 500 mg) in the pre- and postoperative period after phlebectomy attenuated pain, decreased postoperative hematomas, and accelerated their resorption, thus increasing exercise tolerance in the early postoperative period.