Effect of prolonged treatment with compression stockings to prevent post-thrombotic sequelae : a randomized controlled trial

OBJECTIVE: Compression stockings are widely applied after acute proximal deep vein thrombosis, but their efficacy in preventing the post-thrombotic syndrome remains controversial. This study assessed the effect of prolonged compression therapy after a standard treatment of 6 months after acute deep vein thrombosis. METHODS: Of 900 patients screened, we randomly allocated 169 patients with a first or recurrent proximal deep vein thrombosis after receiving 6 months of standard treatment to wear compression stockings or not. Primary efficacy analysis was performed on the end point of emerging skin changes (C4-C6 according to the CEAP classification). Secondary analysis was done on symptoms associated with post-thrombotic syndrome. All analyses were done according to the intention-to-treat principle. RESULTS: The primary end point occurred in 11 patients (13.1%) in the treatment group compared with 17 (20.0%) in the control group (hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.28-1.28; P = .19). Mean follow-up was 3.2 years and 2.9 years, respectively. Five additional patients in the control group required compression therapy owing to post-thrombotic signs and symptoms not included in the primary end point. No venous ulceration was observed in either group. Within subgroup analyses of the primary end point, we observed a large sex-specific difference between women (HR, 0.11; 95% CI, 0.02-0.91) and men (HR, 1.07; 95% CI, 0.42-2.73). Symptom relief was significant in favor of compression treatment during the first year but not thereafter. CONCLUSION: Prolonged compression therapy after proximal deep vein thrombosis significantly reduces symptoms and may prevent post-thrombotic skin changes. Whether these findings translate to the prevention of advanced disease states with ulcerations remains unclear.