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.
|Number of pages||9|
|Early online date||13 May 2020|
|Publication status||Published - 16 May 2020|
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.
- Adjuvants, Pharmaceutic
- Anticoagulants/therapeutic use
- Combined Modality Therapy
- Elective Surgical Procedures/adverse effects
- Heparin, Low-Molecular-Weight/therapeutic use
- Middle Aged
- Postoperative Complications/etiology
- Stockings, Compression
- Treatment Outcome
- Venous Thromboembolism/etiology
- VENOUS THROMBOEMBOLISM
- MOLECULAR-WEIGHT HEPARIN