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

Shalhoub, Joseph and Lawton, Rebecca and Hudson, Jemma and Baker, Christopher and Bradbury, Andrew W and Dhillon, Karen and Everington, Tamara and Gohel, Manjit S and Hamady, Zaed and Hunt, Beverley J and Stansby, Gerrard and Warwick, David and Norrie, John and Davies, Alun H (2020) Graduated compression stockings as adjuvant to pharmaco-thromboprophylaxis in elective surgical patients (GAPS study): randomised controlled trial. BMJ (Clinical research ed.), 369. m1309. ISSN 1756-1833. This article is available to all UHB staff and students via ASK Discovery tool http://tinyurl.com/z795c8c by using their UHB Athens login IDs

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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.

Item Type: Article
Additional Information: This article is available to all UHB staff and students via ASK Discovery tool http://tinyurl.com/z795c8c by using their UHB Athens login IDs
Subjects: QV Pharmacology
WG Cardiovascular system. Cardiology
WH Haemic and lymphatic systems. Haematology
Divisions: Planned IP Care > Vascular
Related URLs:
Depositing User: Mrs Yolande Brookes
Date Deposited: 20 May 2020 11:01
Last Modified: 20 May 2020 11:01
URI: http://www.repository.uhblibrary.co.uk/id/eprint/3090

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