Résumé
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, singlecentre 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 Ginsbergs 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.
| Langue d'origine | English |
|---|---|
| Pages (de-à) | 880-888 |
| Nombre de pages | 9 |
| Journal | The Lancet |
| Volume | 383 |
| Numéro de publication | 9920 |
| DOI | |
| Statut de publication | Published - 2014 |
Note bibliographique
Funding Information:Funding for this study was provided by Canadian Institutes for Health Research (grant number MCT 63142 , MOP 102610 ), with active and placebo stockings provided as in-kind support by Sigvaris Corp. SRK is supported by a National Research Scientist award from the Fonds de recherche du Québec—Santé. MAR is supported by a Career Investigator award from the Heart and Stroke Foundation of Ontario and a Tier 1 Research Chair Award, Faculty of Medicine, University of Ottawa. CK is supported by a Career Investigator award from the Heart and Stroke Foundation of Ontario. JSG is supported by a Career Investigator award from the Heart and Stroke Foundation of Ontario and is a recipient of the David Braley and Nancy Gordon Chair for Investigation of Thromboembolic Diseases. We gratefully acknowledge the contribution of the SOX Trial Central Trial Coordinators Tatiana Vydykhan (study start-up to January, 2007), Hadia Shbaklo (January, 2007, to May, 2008), and Adrielle Houweling (May, 2008, to present). We thank Monika Hudoba, Lindsay Young, and Ria Giakoumakis of Sigvaris Corp for their assistance with distribution of study stockings during the trial. We thank Russell Steele, Department of Mathematics and Statistics, McGill University and Centre for Clinical Epidemiology, Jewish General Hospital for his suggestions on missing data analyses.
ASJC Scopus Subject Areas
- General Medicine