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Graduated compression stockings as adjuvant to pharmaco-thromboprophylaxis in elective surgical patients (GAPS
Joseph Shalhoub1, Rebecca Lawton1, Jemma Hudson2
1Department of Surgery and Cancer, Imperial College London & Imperial Vascular Unit, Imperial College Healthcare NHS Trust, London W6 8RF, UK.
Insights
For patients undergoing elective surgery, low molecular weight heparin (LMWH) alone is as effective as LMWH plus graduated compression stockings (GCS) for preventing venous thromboembolism. These findings suggest GCS may be unnecessary for most surgical patients.
Area of Science:
- Vascular Surgery
- Thrombosis Prevention
- Medical Devices
Background:
- Venous thromboembolism (VTE) is a significant risk following elective surgery.
- Pharmaco-thromboprophylaxis, typically with low molecular weight heparin (LMWH), is standard care.
- The adjuvant role of graduated compression stockings (GCS) alongside LMWH is debated.
Purpose of the Study:
- To determine if graduated compression stockings (GCS) provide additional benefit when used with pharmaco-thromboprophylaxis for VTE prevention in elective surgery patients.
- To assess the non-inferiority of LMWH alone compared to LMWH plus GCS.
Main Methods:
- An open, multicentre, randomised, controlled, non-inferiority trial involving 1905 elective surgical inpatients at moderate or high risk for VTE.
- Participants received either LMWH alone or LMWH plus GCS.
- The primary outcome was the incidence of confirmed deep vein thrombosis or symptomatic pulmonary embolism within 90 days.
Main Results:
- A primary outcome event occurred in 1.7% of patients receiving LMWH alone versus 1.4% in the LMWH plus GCS group.
- LMWH alone was confirmed to be non-inferior to the combination therapy (risk difference 0.30%, 95% CI -0.65% to 1.26%).
- The non-inferiority margin of 3.5% was not crossed (P<0.001).
Conclusions:
- For elective surgery patients at moderate to high VTE risk, LMWH pharmaco-thromboprophylaxis alone is non-inferior to combined LMWH and GCS.
- Graduated compression stockings may be unnecessary for the majority of patients undergoing elective surgery when adequate pharmaco-thromboprophylaxis is administered.
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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