title: Compression stockings to prevent post-thrombotic syndrome: a randomised placebo-controlled trial.
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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  ECS did not prevent PTS after a first proximal DVT, hence our findings do not support routine wearing of ECS after DVT.
  
  
  BACKGROUND
  Canadian Institutes of Health Research.
authors: Centre for Clinical Epidemiology, Jewish General Hospital, Montreal, QC, Canada. Electronic address: susan.kahn@mcgill.ca.
authors: Susan R
authors: SR
authors: Kahn
authors: Centre for Clinical Epidemiology, Jewish General Hospital, Montreal, QC, Canada; Department of Epidemiology and Biostatistics, McGill University, Montreal, QC, Canada.
authors: Stan
authors: S
authors: Shapiro
authors: Department of Medicine, University of Ottawa/Ottawa Hospital, Ottawa, ON, Canada; Ottawa Hospital Research Institute, Ottawa, ON, Canada.
authors: Philip S
authors: PS
authors: Wells
authors: Ottawa Hospital Research Institute, Ottawa, ON, Canada; Thrombosis Program, Division of Hematology, Department of Medicine, University of Ottawa, Ottawa, ON, Canada.
authors: Marc A
authors: MA
authors: Rodger
authors: Division of Hematology, London Health Sciences Centre, London, ON, Canada.
authors: Michael J
authors: MJ
authors: Kovacs
authors: Department of Medicine, Dalhousie University, Halifax, NS, Canada; Capital Health, Halifax, NS, Canada.
authors: David R
authors: DR
authors: Anderson
authors: Centre for Clinical Epidemiology, Jewish General Hospital, Montreal, QC, Canada.
authors: Vicky
authors: V
authors: Tagalakis
authors: Centre for Clinical Epidemiology, Jewish General Hospital, Montreal, QC, Canada.
authors: Adrielle H
authors: AH
authors: Houweling
authors: Centre for Clinical Epidemiology, Jewish General Hospital, Montreal, QC, Canada.
authors: Thierry
authors: T
authors: Ducruet
authors: The Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA; Tufts Clinical and Translational Science Institute, Tufts University, Boston, MA, USA.
authors: Christina
authors: C
authors: Holcroft
authors: International Health Unit, University of Montreal Hospital Research Centre, Montreal, QC, Canada; Department of Health Administration, Faculty of Medicine, University of Montreal, Montreal, QC, Canada.
authors: Mira
authors: M
authors: Johri
authors: Division of Hematology, Montreal General Hospital, Montreal, QC, Canada; St Mary's Hospital, Montreal, QC, Canada.
authors: Susan
authors: S
authors: Solymoss
authors: Department of Medicine, Hôpital Notre-Dame, Montreal, QC, Canada.
authors: Marie-José
authors: MJ
authors: Miron
authors: Division of Hematology, University Health Network, Toronto, ON, Canada.
authors: Erik
authors: E
authors: Yeo
authors: Divisions of Cardiology and Thrombosis, Victoria Heart Institute Foundation, Victoria, BC, Canada.
authors: Reginald
authors: R
authors: Smith
authors: Department of Medicine, McMaster University, Hamilton, ON, Canada; Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada; Karolinska Institute, Stockholm, Sweden.
authors: Sam
authors: S
authors: Schulman
authors: Division of Hematology, Hôpital Maisonneuve-Rosemont, QC, Canada.
authors: Jeannine
authors: J
authors: Kassis
authors: Department of Medicine, McMaster University, Hamilton, ON, Canada.
authors: Clive
authors: C
authors: Kearon
authors: Department of Medicine, Hôpital du Sacré-Coeur, University of Montreal, Montreal, QC, Canada.
authors: Isabelle
authors: I
authors: Chagnon
authors: Department of Medicine, St Boniface General Hospital, University of Manitoba, Winnipeg, Manitoba, Canada.
authors: Turnly
authors: T
authors: Wong
authors: Division of Hematology, CHU de Quebec, Quebec, QC, Canada.
authors: Christine
authors: C
authors: Demers
authors: Division of General Internal Medicine, St Joseph's Hospital, Hamilton, ON, Canada.
authors: Rajendar
authors: R
authors: Hanmiah
authors: Academic Hospital Medicine, Hurley Medical Center, Flint, MI, USA.
authors: Scott
authors: S
authors: Kaatz
authors: Department of Medicine and Department of Clinical Pathology, Sunnybrook Health Sciences Centre and University Health Network, University of Toronto, Toronto, ON, Canada.
authors: Rita
authors: R
authors: Selby
authors: Department of Medicine, Oklahoma University Health Sciences Center, Oklahoma City, OK, USA.
authors: Suman
authors: S
authors: Rathbun
authors: Department of Medicine, Hôpital Pierre-Boucher, Longueuil, QC, Canada.
authors: Sylvie
authors: S
authors: Desmarais
authors: Professional Services, St Mary's Hospital Center, Montreal, QC, Canada.
authors: Lucie
authors: L
authors: Opatrny
authors: Division of Hematology, Duke University Medical Center, Durham, NC, USA.
authors: Thomas L
authors: TL
authors: Ortel
authors: Department of Medicine, McMaster University, Hamilton, ON, Canada.
authors: Jeffrey S
authors: JS
authors: Ginsberg
mesh_terms: D000328:Adult; D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use; D002170:Canada / Q000453:epidemiology; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D054070:Postthrombotic Syndrome / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D012008:Recurrence; D012307:Risk Factors; D012720:Severity of Illness Index; D053828:Stockings, Compression; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D020246:Venous Thrombosis / Q000188:drug therapy
chemical_list: D000925:Anticoagulants