Compression stockings to prevent post-thrombotic syndrome: a randomised placebo-controlled trial Academic Article uri icon

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abstract

  • BACKGROUND: Post-thrombotic syndrome (PTS) is a common and burdensome complication of deep venous thrombosis (DVT). Previous trials suggesting benefit of elastic compression stockings (ECS) to prevent PTS were small, single-centre studies without placebo control. We aimed to assess the efficacy of ECS, compared with placebo stockings, for the prevention of PTS. METHODS: We did a multicentre randomised placebo-controlled trial of active versus placebo ECS used for 2 years to prevent PTS after a first proximal DVT in centres in Canada and the USA. Patients were randomly assigned to study groups with a web-based randomisation system. Patients presenting with a first symptomatic, proximal DVT were potentially eligible to participate. They were excluded if the use of compression stockings was contraindicated, they had an expected lifespan of less than 6 months, geographical inaccessibility precluded return for follow-up visits, they were unable to apply stockings, or they received thrombolytic therapy for the initial treatment of acute DVT. The primary outcome was PTS diagnosed at 6 months or later using Ginsberg's criteria (leg pain and swelling of ≥1 month duration). We used a modified intention to treat Cox regression analysis, supplemented by a prespecified per-protocol analysis of patients who reported frequent use of their allocated treatment. This study is registered with ClinicalTrials.gov, number NCT00143598, and Current Controlled Trials, number ISRCTN71334751. FINDINGS: From 2004 to 2010, 410 patients were randomly assigned to receive active ECS and 396 placebo ECS. The cumulative incidence of PTS was 14·2% in active ECS versus 12·7% in placebo ECS (hazard ratio adjusted for centre 1·13, 95% CI 0·73-1·76; p=0·58). Results were similar in a prespecified per-protocol analysis of patients who reported frequent use of stockings. INTERPRETATION: ECS did not prevent PTS after a first proximal DVT, hence our findings do not support routine wearing of ECS after DVT. FUNDING: Canadian Institutes of Health Research.

authors

  • Kahn, Susan R
  • Shapiro, Stan
  • Wells, Philip S
  • Rodger, Marc A
  • Kovacs, Michael J
  • Anderson, David R
  • Tagalakis, Vicky
  • Houweling, Adrielle H
  • Ducruet, Thierry
  • Holcroft, Christina
  • Johri, Mira
  • Solymoss, Susan
  • Miron, Marie-José
  • Yeo, Erik
  • Smith, Reginald
  • Schulman, Sam
  • Kassis, Jeannine
  • Kearon, Michael Clive
  • Chagnon, Isabelle
  • Wong, Turnly
  • Demers, Christine
  • Hanmiah, Rajendar
  • Kaatz, Scott
  • Selby, Rita
  • Rathbun, Suman
  • Desmarais, Sylvie
  • Opatrny, Lucie
  • Ortel, Thomas L
  • Ginsberg, Jeffrey

publication date

  • March 2014