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; GAPS trial investigators

doi:10.1136/bmj.m1309

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), 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 language	English
Article number	m1309
Number of pages	9
Journal	BMJ
Volume	369
Issue number	8245
Early online date	13 May 2020
DOIs	https://doi.org/10.1136/bmj.m1309
Publication status	Published - 16 May 2020

Bibliographical note

Acknowledgments
The National Institute for Health Research Health Technology Assessment (NIHR HTA) grant applicants, collaborators and details are listed in the supplementary appendix. The views expressed are those of the author(s) and not necessarily those of the UK National Health Service, the NIHR or the Department of Health. We attest that we have obtained appropriate permissions and paid any required fees for use of copyright protected materials.

Funding: This study was funded by the Health Technology Assessment Programme of the National Institute for Health Research (project No 14/140/61) and was sponsored by Imperial College London. Neither organisation had any part in the planning, performing, or reporting of the trial. The funders had no role in study design, data collection, data analysis, data interpretation, or writing of the report.

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

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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., & GAPS trial investigators (2020). Graduated compression stockings as adjuvant to pharmaco-thromboprophylaxis in elective surgical patients (GAPS study): randomised controlled trial. BMJ, 369(8245), Article m1309. https://doi.org/10.1136/bmj.m1309

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 & GAPS trial investigators 2020, 'Graduated compression stockings as adjuvant to pharmaco-thromboprophylaxis in elective surgical patients (GAPS study): randomised controlled trial', BMJ, vol. 369, no. 8245, m1309. https://doi.org/10.1136/bmj.m1309

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

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.",

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",

author = "Joseph Shalhoub and Rebecca Lawton and Jemma Hudson and Christopher Baker and Andrew Bradbury and Karen Dhillon and Tamara Everington and Gohel, {Manjit S.} and Zaed Hamady and Hunt, {Beverley J.} and Gerrard Stansby and David Warwick and John Norrie and Davies, {Alun H.} and {GAPS trial investigators}",

note = "Acknowledgments The National Institute for Health Research Health Technology Assessment (NIHR HTA) grant applicants, collaborators and details are listed in the supplementary appendix. The views expressed are those of the author(s) and not necessarily those of the UK National Health Service, the NIHR or the Department of Health. We attest that we have obtained appropriate permissions and paid any required fees for use of copyright protected materials. Funding: This study was funded by the Health Technology Assessment Programme of the National Institute for Health Research (project No 14/140/61) and was sponsored by Imperial College London. Neither organisation had any part in the planning, performing, or reporting of the trial. The funders had no role in study design, data collection, data analysis, data interpretation, or writing of the report.",

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doi = "10.1136/bmj.m1309",

language = "English",

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TY - JOUR

T1 - Graduated compression stockings as adjuvant to pharmaco-thromboprophylaxis in elective surgical patients (GAPS study)

T2 - randomised controlled trial

AU - Shalhoub, Joseph

AU - Lawton, Rebecca

AU - Hudson, Jemma

AU - Baker, Christopher

AU - Bradbury, Andrew

AU - Dhillon, Karen

AU - Everington, Tamara

AU - Gohel, Manjit S.

AU - Hamady, Zaed

AU - Hunt, Beverley J.

AU - Stansby, Gerrard

AU - Warwick, David

AU - Norrie, John

AU - Davies, Alun H.

AU - GAPS trial investigators

N1 - Acknowledgments The National Institute for Health Research Health Technology Assessment (NIHR HTA) grant applicants, collaborators and details are listed in the supplementary appendix. The views expressed are those of the author(s) and not necessarily those of the UK National Health Service, the NIHR or the Department of Health. We attest that we have obtained appropriate permissions and paid any required fees for use of copyright protected materials. Funding: This study was funded by the Health Technology Assessment Programme of the National Institute for Health Research (project No 14/140/61) and was sponsored by Imperial College London. Neither organisation had any part in the planning, performing, or reporting of the trial. The funders had no role in study design, data collection, data analysis, data interpretation, or writing of the report.

PY - 2020/5/16

Y1 - 2020/5/16

N2 - 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.

AB - 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.

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KW - THROMBOSIS

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KW - RISK

KW - VENOUS THROMBOEMBOLISM

KW - MOLECULAR-WEIGHT HEPARIN

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DO - 10.1136/bmj.m1309

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IS - 8245

M1 - m1309

ER -

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

Abstract

Bibliographical note

Keywords

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