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

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

Randomized Controlled Trial

. 2014 Mar 8;383(9920):880-8.

doi: 10.1016/S0140-6736(13)61902-9. Epub 2013 Dec 6.

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

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, Affiliations

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

Randomized Controlled Trial

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

Susan R Kahn et al. Lancet. 2014.

. 2014 Mar 8;383(9920):880-8.

doi: 10.1016/S0140-6736(13)61902-9. Epub 2013 Dec 6.

Authors

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.

PubMed Disclaimer

Comment in

Elastic compression stockings--is there any benefit?
ten Cate-Hoek AJ. ten Cate-Hoek AJ. Lancet. 2014 Mar 8;383(9920):851-3. doi: 10.1016/S0140-6736(13)62347-8. Epub 2013 Dec 6. Lancet. 2014. PMID: 24315518 No abstract available.
ACP Journal Club. After a first proximal DVT, compression stockings did not prevent the postthrombotic syndrome.
Garcia D. Garcia D. Ann Intern Med. 2014 Apr 15;160(8):JC7. doi: 10.7326/0003-4819-160-8-201404150-02007. Ann Intern Med. 2014. PMID: 24733224 No abstract available.
[Compression stockings can not prevent post-thrombotic syndrome].
Diehm N. Diehm N. MMW Fortschr Med. 2014 Mar 6;156(4):33. MMW Fortschr Med. 2014. PMID: 24908770 German. No abstract available.
Elastic compression stockings fail to prevent post-thrombotic syndrome after a first deep vein thrombosis.
Kanaan A. Kanaan A. Evid Based Nurs. 2015 Jan;18(1):22. doi: 10.1136/eb-2014-101873. Epub 2014 Jun 17. Evid Based Nurs. 2015. PMID: 24938301 No abstract available.
Compression stockings to prevent post-thrombotic syndrome.
Galanaud JP, Righini M, Quéré I. Galanaud JP, et al. Lancet. 2014 Jul 12;384(9938):129. doi: 10.1016/S0140-6736(14)61158-2. Lancet. 2014. PMID: 25016991 No abstract available.
Compression stockings to prevent post-thrombotic syndrome.
Labropoulos N, Gasparis AP, Caprini JA, Partsch H. Labropoulos N, et al. Lancet. 2014 Jul 12;384(9938):129-30. doi: 10.1016/S0140-6736(14)61159-4. Lancet. 2014. PMID: 25016992 No abstract available.
Compression stockings to prevent post-thrombotic syndrome - Authors' reply.
Kahn SR, Shapiro S, Ginsberg JS; SOX trial investigators. Kahn SR, et al. Lancet. 2014 Jul 12;384(9938):130-1. doi: 10.1016/S0140-6736(14)61160-0. Lancet. 2014. PMID: 25016993 No abstract available.
PURLs: skip the compression stockings following DVT.
Bergeson K, Prasad S, Benson J. Bergeson K, et al. J Fam Pract. 2014 Jul;63(7):388-90. J Fam Pract. 2014. PMID: 25198205 Free PMC article.

Cited by

Systematic review on the benefit of graduated compression stockings in the prevention of venous thromboembolism in low-risk surgical patients.
Machin M, Younan HC, Smith S, Salim S, Davies AH, Shalhoub J. Machin M, et al. Phlebology. 2021 Apr;36(3):184-193. doi: 10.1177/0268355520958590. Epub 2020 Oct 4. Phlebology. 2021. PMID: 33016226 Free PMC article.
Pharmacomechanical Catheter-Directed Thrombolysis for Deep-Vein Thrombosis.
Vedantham S, Goldhaber SZ, Julian JA, Kahn SR, Jaff MR, Cohen DJ, Magnuson E, Razavi MK, Comerota AJ, Gornik HL, Murphy TP, Lewis L, Duncan JR, Nieters P, Derfler MC, Filion M, Gu CS, Kee S, Schneider J, Saad N, Blinder M, Moll S, Sacks D, Lin J, Rundback J, Garcia M, Razdan R, VanderWoude E, Marques V, Kearon C; ATTRACT Trial Investigators. Vedantham S, et al. N Engl J Med. 2017 Dec 7;377(23):2240-2252. doi: 10.1056/NEJMoa1615066. N Engl J Med. 2017. PMID: 29211671 Free PMC article. Clinical Trial.
Impact of self-reported race on Villalta Scale postthrombotic syndrome scores and correlation with venous disease-specific quality of life: an exploratory analysis of the Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis Trial.
Shih J, Gu CS, Vedantham S, Kaufman J, Kahn SR. Shih J, et al. Res Pract Thromb Haemost. 2024 Oct 29;8(8):102609. doi: 10.1016/j.rpth.2024.102609. eCollection 2024 Nov. Res Pract Thromb Haemost. 2024. PMID: 39649131 Free PMC article.
Diagnosis and Treatment of Lower Extremity Deep Vein Thrombosis: Korean Practice Guidelines.
Min SK, Kim YH, Joh JH, Kang JM, Park UJ, Kim HK, Chang JH, Park SJ, Kim JY, Bae JI, Choi SY, Kim CW, Park SI, Yim NY, Jeon YS, Yoon HK, Park KH. Min SK, et al. Vasc Specialist Int. 2016 Sep;32(3):77-104. doi: 10.5758/vsi.2016.32.3.77. Epub 2016 Sep 30. Vasc Specialist Int. 2016. PMID: 27699156 Free PMC article. Review.
Pharmaco-mechanical catheter-directed thrombolysis versus recanalization and stenting for post thrombotic syndrome after lower limb deep vein thrombosis: a comparative study.
Gautier G, Douane F, David A, Perret C, Pistorius MA, Goueffic Y, Connault J, Artifoni M, Durant C, Ploton G, Raimbeau A, Bergere G, Robin O, Maurel B, Espitia O. Gautier G, et al. Quant Imaging Med Surg. 2022 Mar;12(3):1664-1673. doi: 10.21037/qims-21-572. Quant Imaging Med Surg. 2022. PMID: 35284255 Free PMC article.

See all "Cited by" articles

Publication types

Actions
Actions
Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Substances

Actions

Associated data

Actions
- Search in PubMed
- Search in ClinicalTrials.gov
Actions
- Search in PubMed
- Search in ISRCTN Controlled Trials

Grants and funding

LinkOut - more resources

Full Text Sources
- ClinicalKey
- Elsevier Science
Other Literature Sources
- H1 Connect - Access expert opinions and insights on biomedical research.
- scite Smart Citations
Medical
- ClinicalTrials.gov

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

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

Collaborators

Affiliations

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

Authors

Collaborators

Affiliations

Abstract

Comment in

Similar articles

Cited by

Publication types

MeSH terms

Substances

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical