Susan R Kahn1, Stan Shapiro2, Philip S Wells3, Marc A Rodger4, Michael J Kovacs5, David R Anderson6, Vicky Tagalakis7, Adrielle H Houweling7, Thierry Ducruet7, Christina Holcroft8, Mira Johri9, Susan Solymoss10, Marie-José Miron11, Erik Yeo12, Reginald Smith13, Sam Schulman14, Jeannine Kassis15, Clive Kearon16, Isabelle Chagnon17, Turnly Wong18, Christine Demers19, Rajendar Hanmiah20, Scott Kaatz21, Rita Selby22, Suman Rathbun23, Sylvie Desmarais24, Lucie Opatrny25, Thomas L Ortel26, Jeffrey S Ginsberg16. 1. Centre for Clinical Epidemiology, Jewish General Hospital, Montreal, QC, Canada. Electronic address: susan.kahn@mcgill.ca. 2. Centre for Clinical Epidemiology, Jewish General Hospital, Montreal, QC, Canada; Department of Epidemiology and Biostatistics, McGill University, Montreal, QC, Canada. 3. Department of Medicine, University of Ottawa/Ottawa Hospital, Ottawa, ON, Canada; Ottawa Hospital Research Institute, Ottawa, ON, Canada. 4. Ottawa Hospital Research Institute, Ottawa, ON, Canada; Thrombosis Program, Division of Hematology, Department of Medicine, University of Ottawa, Ottawa, ON, Canada. 5. Division of Hematology, London Health Sciences Centre, London, ON, Canada. 6. Department of Medicine, Dalhousie University, Halifax, NS, Canada; Capital Health, Halifax, NS, Canada. 7. Centre for Clinical Epidemiology, Jewish General Hospital, Montreal, QC, Canada. 8. 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. 9. 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. 10. Division of Hematology, Montreal General Hospital, Montreal, QC, Canada; St Mary's Hospital, Montreal, QC, Canada. 11. Department of Medicine, Hôpital Notre-Dame, Montreal, QC, Canada. 12. Division of Hematology, University Health Network, Toronto, ON, Canada. 13. Divisions of Cardiology and Thrombosis, Victoria Heart Institute Foundation, Victoria, BC, Canada. 14. Department of Medicine, McMaster University, Hamilton, ON, Canada; Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada; Karolinska Institute, Stockholm, Sweden. 15. Division of Hematology, Hôpital Maisonneuve-Rosemont, QC, Canada. 16. Department of Medicine, McMaster University, Hamilton, ON, Canada. 17. Department of Medicine, Hôpital du Sacré-Coeur, University of Montreal, Montreal, QC, Canada. 18. Department of Medicine, St Boniface General Hospital, University of Manitoba, Winnipeg, Manitoba, Canada. 19. Division of Hematology, CHU de Quebec, Quebec, QC, Canada. 20. Division of General Internal Medicine, St Joseph's Hospital, Hamilton, ON, Canada. 21. Academic Hospital Medicine, Hurley Medical Center, Flint, MI, USA. 22. Department of Medicine and Department of Clinical Pathology, Sunnybrook Health Sciences Centre and University Health Network, University of Toronto, Toronto, ON, Canada. 23. Department of Medicine, Oklahoma University Health Sciences Center, Oklahoma City, OK, USA. 24. Department of Medicine, Hôpital Pierre-Boucher, Longueuil, QC, Canada. 25. Professional Services, St Mary's Hospital Center, Montreal, QC, Canada. 26. Division of Hematology, Duke University Medical Center, Durham, NC, USA.
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.
RCT Entities:
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.
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