Résumé
Background: The present randomized double-blind multicenter study was designed to assess the efficacy of a progressive compressive stocking (new concept with maximal pressure at calf), compared to a degressive compressive stocking graded 30 mm Hg, evaluating the improvement of lower leg symptoms of chronic venous insufficiency (CVI) in ambulatory patients with moderate to severe chronic venous disease.
Methods: Both gender outpatients presenting symptomatic moderate to severe CVI were eligible for a treatment by compressive stockings. Patients were randomly assigned to receive either degressive compressive stockings (30 mm Hg at ankle, 21 mm Hg at upper calf) or progressive compressive stockings (10 mm Hg at ankle, 23 mm Hg at upper calf). The primary outcome, evaluated after 3 months, was a composite success outcome, including improvement of pain or heavy legs without onset of either ulcer, deep or superficial vein thrombosis of the lower limbs, or pulmonary embolism. The ease of application of the compressive stockings reported by patients was one of secondary outcome.
Results: Overall, 401 patients (199 in the progressive compressive stocking group and 202 in the degressive compressive stocking group) were randomized by 44 angiologists in France. Among them, 66% were classified in the C3 CEAP category. The rate of success was significantly higher in the progressive compressive stocking group compared to the degressive compressive stocking group (70.0% vs 59.6%; relative risk, 1.18; 95% confidence interval, 1.02-1.37; P = .03). This was mainly due to more frequent symptom improvement in the progressive compressive stocking group. The compressive stockings were considered easy to apply by 81.3% of patients in the progressive compressive stocking group vs 49.7% of patients in the degressive compressive stocking group (P < .0001). The rate of related serious adverse events was low and similar in both groups.
Conclusions: This trial has demonstrated that progressive compressive stockings are more effective than usual degressive compressive stockings in the improvement of pain and lower leg symptoms in patients with CVI. Moreover, progressive compressive stockings were easier to apply, raising no safety concern at 3 months. (J Vasc Surg 2012;56:1344-50.)