ten Cate-Hoek AJ, et al. - In this study, researchers assessed the safety and efficacy of individualised duration of compression therapy vs the standard duration of 24 months following an initial treatment period of 6 months. It was noticed that for the prevention of post-thrombotic syndrome, individualised therapy with elastic compression stockings was non-inferior to standard duration of therapy of 24 months. Here individualization of the duration proved effective and shortened the length of therapy required, potentially enhancing patients' wellbeing.

Methods

• A multicentre, randomised, single-blind, allocation-concealed, non-inferiority trial was performed at 12 hospitals in the Netherlands and two in Italy.
• Random assignment was performed of patients (1:1) with acute proximal deep vein thrombosis of the leg and without pre-existent venous insufficiency (Clinical Etiological Anatomical and Pathophysiological score
• With a web-based automatic randomisation programme (TENALEA) and a random block size (2–12), they performed randomisation; stratification was performed by centre, age, and body-mass index.
• In accordance to the three prespecified protocols, compression was applied within 24 h of diagnosis in the initial phase.
• For this study, all patients received elastic compression stockings (30–40 mm Hg) for 6 months; patients were instructed to wear them every day during ambulant hours.
• Thereafter, on the basis of clinical signs and symptoms scored according to the Villalta post-thrombotic syndrome scale, treatment was tailored; patients assigned to individualised therapy with two consecutive Villalta scores of 4 or less were instructed to stop using the stockings.
• Patients were followed up for 2 years.
• They evaluated patients at 5 clinic visits at study inclusion, and 3, 6, 12, and 24 months after diagnosis (stocking allocation was not revealed to the assessors).
• The proportion of patients with post-thrombotic syndrome at 24 months diagnosed according to original Villalta criteria (a score of ≥5 on two consecutive occasions at least 3 months apart) determined by intention to treat was assessed as the primary outcome.
• For this study, the predefined non-inferiority margin for the difference in success rates was set at 7·5%.

Results

• Researchers enrolled 865 patients from March 22, 2011, to July 1, 2015; 437 were randomly assigned to individualised duration compression stockings and 428 to standard duration.
• In the intervention group, 283 (66%) of 432 patients were advised before 24 months to stop wearing elastic compression stockings (236 [55%] of 432 patients after 6 months, and 47 [11%] of 432 at 12 months).
• In 125 (29%) of 432 patients receiving individualised duration of therapy and in 118 (28%) of 424 receiving standard duration of therapy (odds ratio for difference 1·06, 95% CI 0·78 to 1·44) reported post-thrombotic syndrome.
• The absolute difference of 1·1% (95% CI -5·2 to 7·3) was noticed, thus meeting the non-inferiority margin.
• Death of 24 patients was reported, 17 (4%) in the individualised treatment group and seven (2%) in the standard duration group.
• No deaths were related to treatment.
• In relation to the intervention, no serious adverse events occurred.