Graduated compression stockings as adjuvant to pharmaco-thromboprophylaxis in elective surgical patients (GAPS study): randomised controlled trial

Joseph Shalhoub, Rebecca Lawton, Jemma Hudson, Christopher Baker, Andrew Bradbury, Karen Dhillon, Tamara Everington, Manjit S. Gohel, Zaed Hamady, Beverley J. Hunt, Gerrard Stansby, David Warwick, John Norrie, Alun H. Davies* (Corresponding Author), the GAPS trial investigators

*Corresponding author for this work

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Abstract

Objectives To investigate whether the use of graduated compression stockings (GCS) offers any adjuvant benefit when pharmaco-thromboprophylaxis is used for venous thromboembolism prophylaxis in patients undergoing elective surgery. Design Open, multicentre, randomised, controlled, non-inferiority trial. Setting Seven National Health Service tertiary hospitals in the United Kingdom. Participants 1905 elective surgical inpatients (≥18 years) assessed as being at moderate or high risk of venous thromboembolism were eligible and consented to participate. Intervention Participants were randomly assigned (1:1) to receive low molecular weight heparin (LMWH) pharmaco-thromboprophylaxis alone or LMWH pharmaco-thromboprophylaxis and GCS. Outcome measures The primary outcome was imaging confirmed lower limb deep vein thrombosis with or without symptoms, or pulmonary embolism with symptoms within 90 days of surgery. Secondary outcome measures were quality of life, compliance with stockings and LMWH, lower limb complications related to GCS, bleeding complications, adverse reactions to LMWH, and all cause mortality. Results Between May 2016 and January 2019, 1905 participants were randomised. 1858 were included in the intention to treat analysis (17 were identified as ineligible after randomisation and 30 did not undergo surgery). A primary outcome event occurred in 16 of 937 (1.7%) patients in the LMWH alone group compared with 13 of 921 (1.4%) in the LMWH and GCS group. The risk difference between the two groups was 0.30% (95% confidence interval −0.65% to 1.26%). Because the 95% confidence interval did not cross the non-inferiority margin of 3.5% (P<0.001 for non-inferiority), LMWH alone was confirmed to be non-inferior. Conclusions For patients who have elective surgery and are at moderate or high risk of venous thromboembolism, administration of pharmaco-thromboprophylaxis alone is non-inferior to a combination of pharmaco-thromboprophylaxis and GCS. These findings indicate that GCS might be unnecessary in most patients undergoing elective surgery. Trial registration ISRCTN13911492.
Original languageEnglish
Article numberm1309
Number of pages9
JournalBMJ
Volume369
Issue number8245
Early online date13 May 2020
DOIs
Publication statusPublished - 16 May 2020

Keywords

  • Adjuvants, Pharmaceutic
  • Adult
  • Aged
  • Anticoagulants/therapeutic use
  • Combined Modality Therapy
  • Elective Surgical Procedures/adverse effects
  • Female
  • Heparin, Low-Molecular-Weight/therapeutic use
  • Humans
  • Male
  • Middle Aged
  • Postoperative Complications/etiology
  • Stockings, Compression
  • Treatment Outcome
  • Venous Thromboembolism/etiology
  • SURGERY
  • MULTICENTER
  • THROMBOSIS
  • PREVENTION
  • RISK
  • VENOUS THROMBOEMBOLISM
  • MOLECULAR-WEIGHT HEPARIN

ASJC Scopus subject areas

  • Medicine(all)

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    Shalhoub, J., Lawton, R., Hudson, J., Baker, C., Bradbury, A., Dhillon, K., Everington, T., Gohel, M. S., Hamady, Z., Hunt, B. J., Stansby, G., Warwick, D., Norrie, J., Davies, A. H., & the GAPS trial investigators (2020). Graduated compression stockings as adjuvant to pharmaco-thromboprophylaxis in elective surgical patients (GAPS study): randomised controlled trial. BMJ, 369(8245), [m1309]. https://doi.org/10.1136/bmj.m1309