Compression stockings to prevent post-thrombotic syndrome: a randomised placebo-controlled trial

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

doi:10.1016/S0140-6736(13)61902-9

Compression stockings to prevent post-thrombotic syndrome: a randomised placebo-controlled trial

Lancet. 2014 Mar 8;383(9920):880-8. doi: 10.1016/S0140-6736(13)61902-9. Epub 2013 Dec 6.

Authors

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; SOX trial investigators

Collaborators

SOX trial investigators:
E Lang, E Shulikovsky, M Forgie, C Hilliker, V Borsella, J Chen, F Hallé, A Levac, R Larose, C Blais, A Lazo-Langner, M McLean, B Morrow, R Corpuz, B St-Jacques, S Finkenbine, M Dominquez, A Roussin, F Joyal, V Daniel, S Paris, D Bélisle, D Forand, B Gallant, L Gray, A MacNeil, S Bates, P Stevens, B Brien, A McLeod, R Wu, M Dzyuba, S Jenkins, S Sorensen, L Reimer, N Lounsbury, J Eikelboom, L Rudd-Scott, M Zondag, M Robinson, D-T Nguyen, D Sylvestre, J Trinh Lu, L Chevalier, K Mendelew, K McTavish, K Nguyen, P Gross, A Lee, L-A Linkins, J Weitz, T Winkworth, M Thompson, D Donovan, M Laurier, N Routhier, A-M Mansour, M Helou, G Grégoire, C Chagnon, C Nadon, G Drobot, J Arbez, S Erikson-Nesmith, R Delage, C Doyle, J Morin, P-F Leblond, C Petitclerc, G Cantin, C Jobin, Y Hébert, J Poulin, J Douketis, M Crowther, W Lim, T Schnurr, R Jay, W Bartle, W Geerts, F Sealey, L Kaus, N Fortin, K Riches, C Barber, F Spencer, T Lyon, D Magier, S Robinson, H Gikas, S Ellsworth, S Rathbun, M A Gleim, S Adams, C Mette, C Holcroft, T Ducruet, A Hirsch, M Blostein, G Raskob, S Vesely, D Thompson, B L Davidson

Affiliations

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.

PMID: 24315521
DOI: 10.1016/S0140-6736(13)61902-9

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.

Publication types

Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Aged
Anticoagulants / therapeutic use
Canada / epidemiology
Combined Modality Therapy
Double-Blind Method
Female
Humans
Incidence
Male
Middle Aged
Postthrombotic Syndrome / epidemiology
Postthrombotic Syndrome / etiology
Postthrombotic Syndrome / prevention & control*
Recurrence
Risk Factors
Severity of Illness Index
Stockings, Compression*
Treatment Outcome
United States / epidemiology
Venous Thrombosis / drug therapy

Compression stockings to prevent post-thrombotic syndrome: a randomised placebo-controlled trial

Authors

Collaborators

Affiliations

Abstract

Publication types

MeSH terms

Substances

Associated data

Grants and funding