Graduated compression stockings as an adjuvant to pharmaco-thromboprophylaxis in elective surgical patients (GAPS study): a randomised controlled trial
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Supplementary information
Published version
Author(s)
Type
Journal Article
Abstract
Objectives:
Does the use of GCS offer any adjuvant benefit when pharmaco-thromboprophylaxis is used for VTE prophylaxis?
Design:
Open, multicentre, randomised, controlled, non-inferiority trial.
Setting:
Seven National Health Service tertiary hospitals in the United Kingdom.
Participants:
1905 elective surgical inpatients, aged >18 years assessed as being at moderate or high risk of VTE were eligible and consented to participate.
Intervention:
Participants were randomly assigned (1:1) to receive either low molecular weight heparin (LMWH) pharmaco-thromboprophylaxis alone or LMWH pharmaco-thromboprophylaxis and graduated compression stockings (GCS).
Outcome measures:
The primary endpoint was a combination of imaging confirmed asymptomatic and symptomatic lower limb deep vein thrombosis and/or symptomatic pulmonary embolism within 90 days of surgery. Secondary outcome measures were quality of life, compliance with stockings and LMWH, GCS-related lower limb complications, bleeding complications, adverse reactions to LMWH, and all-cause mortality.
Results:
Between May 2016 and January 2019, 1905 participants were randomised, of which 1858 were included in the intention-to-treat analysis (17 identified as ineligible post-randomisation and 30 did not undergo surgery). A primary-outcome event occurred in 16/937 (1.7%) patients in the LMWH alone arm compared to 13/921 (1.4%) in the LMWH and GCS arm. The risk difference between LMWH and LMWH and GCS was 0.30% (95% confidence interval [CI} -0.65% to 1.26%). As the 95% CI did not cross the non-inferiority margin of 3.5% (p-value <0.001 for non-inferiority), LMWH alone was confirmed as being non-inferior.
Conclusions:
For elective surgical patients at moderate or high risk of VTE, administration of pharmaco-thromboprophylaxis alone is non-inferior to a combination of pharmaco-thromboprophylaxis and graduated compression stockings. These findings indicate that graduated compression stockings may be unnecessary in most elective surgical patients.
Does the use of GCS offer any adjuvant benefit when pharmaco-thromboprophylaxis is used for VTE prophylaxis?
Design:
Open, multicentre, randomised, controlled, non-inferiority trial.
Setting:
Seven National Health Service tertiary hospitals in the United Kingdom.
Participants:
1905 elective surgical inpatients, aged >18 years assessed as being at moderate or high risk of VTE were eligible and consented to participate.
Intervention:
Participants were randomly assigned (1:1) to receive either low molecular weight heparin (LMWH) pharmaco-thromboprophylaxis alone or LMWH pharmaco-thromboprophylaxis and graduated compression stockings (GCS).
Outcome measures:
The primary endpoint was a combination of imaging confirmed asymptomatic and symptomatic lower limb deep vein thrombosis and/or symptomatic pulmonary embolism within 90 days of surgery. Secondary outcome measures were quality of life, compliance with stockings and LMWH, GCS-related lower limb complications, bleeding complications, adverse reactions to LMWH, and all-cause mortality.
Results:
Between May 2016 and January 2019, 1905 participants were randomised, of which 1858 were included in the intention-to-treat analysis (17 identified as ineligible post-randomisation and 30 did not undergo surgery). A primary-outcome event occurred in 16/937 (1.7%) patients in the LMWH alone arm compared to 13/921 (1.4%) in the LMWH and GCS arm. The risk difference between LMWH and LMWH and GCS was 0.30% (95% confidence interval [CI} -0.65% to 1.26%). As the 95% CI did not cross the non-inferiority margin of 3.5% (p-value <0.001 for non-inferiority), LMWH alone was confirmed as being non-inferior.
Conclusions:
For elective surgical patients at moderate or high risk of VTE, administration of pharmaco-thromboprophylaxis alone is non-inferior to a combination of pharmaco-thromboprophylaxis and graduated compression stockings. These findings indicate that graduated compression stockings may be unnecessary in most elective surgical patients.
Date Issued
2020-05-13
Date Acceptance
2020-03-18
Citation
BMJ: British Medical Journal, 2020, 369
ISSN
0959-535X
Publisher
BMJ Publishing Group
Journal / Book Title
BMJ: British Medical Journal
Volume
369
Copyright Statement
© 2020 The Author(s). This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/.
Sponsor
National Institute for Health Research
Grant Number
NIHR HTA Project Grant 14/140/61
Subjects
GAPS trial investigators
1103 Clinical Sciences
1117 Public Health and Health Services
General & Internal Medicine
Publication Status
Published