Compression stockings in addition to low-molecular-weight heparin to prevent venous thromboembolism in surgical inpatients requiring pharmacoprophylaxis: the GAPS non-inferiority RCT

Background Patients admitted to hospital for surgery are at an increased risk of venous thromboembolism. Pharmaco-thromboprophylaxis and mechanical prophylaxis (usually graduated compression stockings or intermittent pneumatic compression) have been shown to reduce the incidence of venous thromboembolism. The evidence base supporting the National Institute for Health and Care Excellence’s recommendation for the use of graduated compression stockings for venous thromboembolism prevention in the UK has recently been challenged. It is unclear if the risks and costs associated with graduated compression stockings are justified for deep-vein thrombosis prevention in moderate- and high-risk elective surgical inpatients receiving low-dose low-molecular-weight heparin pharmaco-thromboprophylaxis. Objectives The primary objective was to compare the venous thromboembolism rate in elective surgical inpatients at moderate or high risk of venous thromboembolism who were receiving either graduated compression stockings and low-dose low-molecular-weight heparin (standard care) or low-dose low-molecular-weight heparin alone (intervention). Design This was a pragmatic, multicentre, prospective, non-inferiority, randomised controlled trial. Setting This took place in secondary care NHS hospitals in the UK. Participants Patients aged ≥ 18 years who were assessed to be at moderate or high risk of venous thromboembolism according to the NHS England venous thromboembolism risk assessment tool (or the trust equivalent based on this form) and who were not contraindicated to low-molecular-weight heparin or graduated compression stockings were deemed eligible to take part. Interventions Participants were randomised 1 : 1 to either low-molecular-weight heparin or low-molecular-weight heparin and graduated compression stockings. Main outcome measures The primary outcome measure was venous thromboembolism up to 90 days after surgery. A combined end point of duplex ultrasound-proven new lower-limb deep-vein thrombosis (symptomatic or asymptomatic) plus imaging-confirmed symptomatic pulmonary embolism. Secondary outcomes included quality of life, compliance with graduated compression stockings and low-molecular-weight heparin during admission, and all-cause mortality. Results A total of 1905 participants were randomised and 1858 were included in the intention-to-treat analysis. A primary outcome event occurred in 16 out of 937 (1.7%) patients in the low-molecular-weight heparin-alone arm compared with 13 out of 921 (1.4%) patients in the low-molecular-weight heparin plus graduated compression stockings arm. The risk difference between low-molecular-weight heparin and low-molecular-weight heparin plus graduated compression stockings was 0.30% (95% confidence interval –0.65% to 1.26%). As the 95% confidence interval did not cross the non-inferiority margin of 3.5% (p < 0.001 for non-inferiority), the results indicate that non-inferiority of low-molecular-weight heparin alone was shown. Limitations In total, 13% of patients did not receive a duplex ultrasound scan that could have detected further asymptomatic deep-vein thrombosis. However, missing scans were balanced between both trial arms. The subpopulation of those aged ≥ 65 years assessed as being at a moderate risk of venous thromboembolism was under-represented in the study; however, this reflects that this group is under-represented in the general population. Conclusions For elective surgical patients at moderate or high risk of venous thromboembolism, 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 for most elective surgical patients. Future work Further studies are required to evaluate whether or not adjuvant graduated compression stockings have a role in patients receiving extended thromboprophylaxis, beyond the period of hospital admission, following elective surgery or in patients undergoing emergency surgical procedures. Trial registration Current Controlled Trials ISRCTN13911492. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 69. See the NIHR Journals Library website for further project information.

Healthcare professionals’ knowledge, attitudes, and practices regarding graduated compression stockings: a survey of China’s big-data network

Background The accurate identification of venous thromboembolism prophylaxis implementation barriers is an important part of prophylaxis prevention. However, in China, data to help identify these barriers is limited. This study has two objectives: 1) to determine the knowledge, attitudes, and practices (KAPs) of healthcare professionals regarding graduated compression stockings (GCS) since the launch of the National Program for the Prevention and Management of Pulmonary Embolism (PE) and Deep Venous Thrombosis (DVT) in October 2018 and 2) to identify the obstacles and assist the program. Methods This was a cross-sectional study of 5070 healthcare professionals in China. We used exploratory factor and reliability analyses to evaluate the researcher-designed questionnaire’s reliability and validity. The formal questionnaire, which included demographic data, knowledge, attitudes, and clinical practice patterns, was distributed to healthcare professionals. Results Of the 5070 respondents, 32.5% had a good knowledge of GCS, 78.5% had a positive attitude towards their use, and 34.0% exhibited normative behavior when applying them. The KAPs of healthcare professionals towards GCS were significantly correlated with one another. Binary logistic regression suggested that the training received by healthcare professionals was an important factor affecting their knowledge regarding GCS usage. Conclusions The training provided for the use of GCS in China cannot meet medical staff needs and deserves more attention from policy makers. This represents an obstacle for venous thromboembolism prophylaxis, which restricts the effective implementation of the National Program for Prevention and Management of PE and DVT.

Systematic review on the benefit of graduated compression stockings in the prevention of venous thromboembolism in low-risk surgical patients

Objectives The aim of this systematic review is to assess the performance of graduated compression stockings (GCS) in comparison to no venous thromboembolism (VTE) prophylaxis in the prevention of hospital-acquired thrombosis in low-risk surgical patients undergoing short-stay procedures. Methods Aligning with PRISMA guidelines, online databases MEDLINE and EMBASE, Cochrane Library® and trial registries were searched. Eligible articles reported the VTE rate in low-risk surgical patients either receiving GCS or no VTE prophylaxis. Results Narrative synthesis was performed on a single eligible article. The included study arm consisted of participants undergoing knee arthroscopy with the use of GCS alone reporting a total of 29 VTE events (4.4%), 16 of which were asymptomatic DVTs (2.4%). Conclusion There is a complete lack of evidence to support the use of GCS in the prevention of HAT for low-risk surgical patients. An adequately powered trial is required to provide level-IA evidence to support this practice.

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

ObjectivesTo 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.DesignOpen, multicentre, randomised, controlled, non-inferiority trial.SettingSeven National Health Service tertiary hospitals in the United Kingdom.Participants1905 elective surgical inpatients (≥18 years) assessed as being at moderate or high risk of venous thromboembolism were eligible and consented to participate.InterventionParticipants were randomly assigned (1:1) to receive low molecular weight heparin (LMWH) pharmaco-thromboprophylaxis alone or LMWH pharmaco-thromboprophylaxis and GCS.Outcome measuresThe 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.ResultsBetween 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.ConclusionsFor 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 registrationISRCTN13911492.

WeMPiC protocol to prevent Deep Venous Thrombosis in patients with neurosurgical diseases

Background: Deep Venous Thrombosis is a common yet difficult problem to prevent in neurosurgical patients. Recent trials did not find sufficient evidence to support use of graduated compression stockings, however we believe, this inefficiency may be due to the method of application which needs to be modified. We have been following a patient specific mechanical prophylaxis protocol, nicknamed WeMPiC. This study aims to evaluate the effectiveness of WeMPiC protocol. Methods: An observational cohort study was performed including consecutive patients admitted to neurosurgical ICU who were bedridden for >7 days between April 2014 and September 2017. We developed WeMPiC protocol of early weaning off, early mobilization, limb physiotherapy and alternate two hours on and off application of thigh length graduated compression stockings. Lower limbs compression ultrasound studies were performed on alternate days. Results: One hundred thirty-one patients were included in the study. Mean age of patients was 53.7+ 20.6 years. Of these patients, 52.7% had stroke (91% had hemorrhages), 32.1% had head injury and 7.6% each had spine problem and brain tumor each. five (3.8%) developed deep venous thrombosis on the 4th and 6th day of ICU stay, mainly in popliteal veins (2.3%) and femoral veins (1.5%). Deep venous thrombosis was associated with younger age (47 years, p=0.005), ICU stay (13 days, p=0.014), Wells’ score (4.6, p<0.0001) and Poor Glasgow Coma Score at presentation (9, p=0.004). Power of study calculated for the cohort incidence of 3.8% was 100%. Cost benefit of $336 with WeMPiC protocol was seen as compared to the Low molecular weight heparin prophylaxis over four weeks. Conclusions: Compared to incidence of 12.1% in CLOTS 3 trial among the unexposed patients, we report a risk reduction of 8.3% with WeMPiC protocol which is cost effective and highly applicable in resource constraint scenarios.

Effects of graduated compression stockings, local vibration and their combination on popliteal venous blood velocity

Objectives The purpose of this pilot study was to examine and compare the effects of graduated compression stockings, local vibration, and combined graduated compression stockings and local vibration on popliteal venous blood velocity. Method Twenty-four healthy subjects received four 15 min interventions (control, graduated compression stockings alone, local vibration alone, and combined graduated compression stockings and local vibration), while resting inactive in the prone position. Popliteal vein blood velocity was investigated before (PRE) and at the end (POST) of each intervention using Doppler ultrasound. Results At POST, peak velocity was reported to be 26.3 ± 53.5% ( p < 0.05) greater for local vibration than control (CONT). Peak velocity was 46.2 ± 54.6% ( p < 0.001) and 21.1 ± 37.6% ( p < 0.01) higher for graduated compression stockings than CONT and local vibration, respectively. Graduated compression stockings + local vibration presented 64.1 ± 58.0% ( p < 0.001), 38.4 ± 52.4% ( p < 0.001) and 15.0 ± 31.6% ( p < 0.05) greater values than CONT, local vibration and graduated compression stockings, respectively. Conclusions This study demonstrated an increase in popliteal venous blood velocity after graduated compression stockings and local vibration application. Their combination provided the greatest effects.