Below-Knee Elastic Compression Stockings To Prevent the Post-Thrombotic Syndrome

A Randomized, Controlled Trial

  1. Paolo Prandoni, MD, PhD;
  2. Anthonie W.A. Lensing, MD, PhD;
  3. Martin H. Prins, MD, PhD;
  4. Michela Frulla, MD;
  5. Antonio Marchiori, MD;
  6. Enrico Bernardi, MD, PhD;
  7. Daniela Tormene, MD;
  8. Laura Mosena, MD;
  9. Antonio Pagnan, MD; and
  10. Antonio Girolami, MD
  1. From University Hospital of Padua, Padua, Italy; and Academic Medical Center, Amsterdam, and Academic Hospital, Maastricht, the Netherlands.

    Abstract

    Background: Because only limited evidence suggests that elastic stockings prevent the post-thrombotic syndrome in patients with symptomatic deep venous thrombosis (DVT), these stockings are not widely used.

    Objective: To evaluate the efficacy of compression elastic stockings for prevention of the post-thrombotic syndrome in patients with proximal DVT.

    Design: Randomized, controlled clinical trial.

    Setting: University hospital.

    Patients: 180 consecutive patients with a first episode of symptomatic proximal DVT who received conventional anticoagulant treatment.

    Interventions: Before discharge, patients were randomly assigned to wear or not wear below-knee compression elastic stockings (30 to 40 mm Hg at the ankle) for 2 years. Follow-up was performed for up to 5 years.

    Measurements: The presence and severity of the post-thrombotic syndrome were scored by using a standardized scale.

    Results: Post-thrombotic sequelae developed in 44 of 90 controls (severe in 10) and in 23 of 90 patients wearing elastic stockings (severe in 3). All but 1 event developed in the first 2 years. The cumulative incidence of the post-thrombotic syndrome in the control group versus the elastic stockings group was 40.0% (95% CI, 29.9% to 50.1%) versus 21.1% (CI, 12.7% to 29.5%) after 6 months, 46.7% (CI, 36.4% to 57.0%) versus 22.2% (CI, 13.8% to 30.7%) after 1 year, and 49.1% (CI, 38.7% to 59.4%) versus 24.5% (CI, 15.6% to 33.4%) after 2 years. After adjustment for baseline characteristics, the hazard ratio for the post-thrombotic syndrome in the elastic stockings group compared with controls was 0.49 (CI, 0.29 to 0.84; P = 0.011).

    Limitations: This study lacked a double-blind design.

    Conclusions: Post-thrombotic sequelae develop in almost half of patients with proximal DVT. Below-knee compression elastic stockings reduce this rate by approximately 50%.

    Article and Author Information

    • Grant Support: By a grant from New Medical Service, Linea Flebologica Flebysan, Rovigo, Italy.

    • Potential Financial Conflicts of Interest: None disclosed.

    • Requests for Single Reprints: Paolo Prandoni, MD, Department of Medical and Surgical Sciences, 2nd Division of Internal Medicine, University Hospital of Padua, Via Ospedale Civile 105, 35128 Padua, Italy; e-mail, paoloprandoni{at}tin.it.

    • Current Author Addresses: Drs. Prandoni, Frulla, Marchiori, Bernardi, Tormene, Mosena, Pagnan, and Girolami: Department of Medical and Surgical Sciences, 2nd Division of Internal Medicine, University Hospital of Padua, Via Ospedale Civile 105, 35128 Padua, Italy.

    • Dr. Lensing: Center for Vascular Medicine, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.

    • Dr. Prins: Department of Clinical Epidemiology and Technology Assessment, Academic Hospital, P.O. Box 5800, 6202 AZ Maastricht, the Netherlands.

    • Author Contributions: Conception and design: P. Prandoni, A.W.A. Lensing, M. Frulla.

    • Analysis and interpretation of the data: M.H. Prins, A. Marchiori, E. Bernardi.

    • Drafting of the article: P. Prandoni, A.W.A. Lensing, M.H. Prins, E. Bernardi.

    • Critical revision of the article for important intellectual content: A. Pagnan, A. Girolami.

    • Final approval of the article: P. Prandoni, A.W.A. Lensing, M.H. Prins, M. Frulla, A. Marchiori, E. Bernardi, D. Tormene, L. Mosena, A. Pagnan, A. Girolami.

    • Provision of study materials or patients: P. Prandoni, M. Frulla, D. Tormene, L. Mosena.

    • Statistical expertise: M.H. Prins, A. Marchiori, E. Bernardi.

    • Obtaining of funding: P. Prandoni.

    • Administrative, technical, or logistic support: P. Prandoni, D. Tormene, A. Pagnan, A. Girolami.

    • Collection and assembly of data: P. Prandoni, M. Frulla, D. Tormene, L. Mosena.

    Summary for Patients

    • Summaries for Patients:Can Compression Stockings Prevent the Post-Thrombotic Syndrome? Ann Intern Med August 17, 2004 141:I-12
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    1. Ann Intern Med August 17, 2004 vol. 141 no. 4 249-256
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