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.