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

Lookup NU author(s): Professor Gerard Stansby



This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. No commercial re-use. See rights and permissions. Published by BMJ.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.

Publication metadata

Author(s): Shalhoub J, Lawton R, Hudson J, Baker C, Bradbury A, Dhillon K, Everington T, Gohel MS, Hamady Z, Hunt BJ, Stansby G, Warwick D, Norrie J, Davies AH

Publication type: Article

Publication status: Published

Journal: BMJ

Year: 2020

Volume: 369

Issue: 8245

Print publication date: 16/05/2020

Online publication date: 13/05/2020

Acceptance date: 18/03/2020

Date deposited: 08/02/2021

ISSN (print): 0959-535X

ISSN (electronic): 1756-1833

Publisher: BMJ Group


DOI: 10.1136/bmj.m1309

PubMed id: 32404430


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