Dataset Information

Implementation of the graduated compression as an adjunct to pharmaco-thromboprophylaxis in surgery trial results across the UK.

ABSTRACT:

Objectives

This study aims to examine uptake and dissemination of a National Institute for Health Research (NIHR) Health Technology Assessment (HTA)-funded trial - Graduated compression as an Adjunct to Pharmaco-thromboprophylaxis in Surgery (GAPS) (project number: 14/140/61) amongst health professionals in the UK. This study aims to evaluate the impact of the trial on venous thromboembolism (VTE) prevention policies 7 months after publication.

Method

A 12-question online survey emailed to 2750 individuals via several vascular societies, 34 VTE Exemplar Centre leads and 1 charity over a 3-month period.

Results

In total, 250 responses were received; a 9.1% response rate. Over half of all respondents (52.4%) had read the GAPS trial results prior to completing the survey. Precisely, 77.1% said their hospital had not yet made changes or did not intend to make changes to local hospital VTE policy based on the GAPS trial.

Conclusions

Findings must be interpreted in the context of the low response rate. Further in-depth interviews would aid understanding of barriers to implementing change.

SUBMITTER: Lawton R

PROVIDER: S-EPMC9379381 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature

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Publications

Implementation of the graduated compression as an adjunct to pharmaco-thromboprophylaxis in surgery trial results across the UK.

Lawton Rebecca R Shalhoub Joseph J Davies Alun H AH

Phlebology 20220424 7

<h4>Objectives</h4>This study aims to examine uptake and dissemination of a National Institute for Health Research (NIHR) Health Technology Assessment (HTA)-funded trial - Graduated compression as an Adjunct to Pharmaco-thromboprophylaxis in Surgery (GAPS) (project number: 14/140/61) amongst health professionals in the UK. This study aims to evaluate the impact of the trial on venous thromboembolism (VTE) prevention policies 7 months after publication.<h4>Method</h4>A 12-question online survey e ...[more]

PMID: 35466796

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Project description: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.

Project description:ObjectivesAtrial fibrillation (AF) reduces survival and quality of life (QoL). It can be treated at the time of major cardiac surgery using ablation procedures ranging from simple pulmonary vein isolation to a full maze procedure. The aim of this study is to evaluate the impact of adjunct AF surgery as currently performed on sinus rhythm (SR) restoration, survival, QoL and cost-effectiveness.MethodsIn a multicentre, Phase III, pragmatic, double-blinded, parallel-armed randomized controlled trial, 352 cardiac surgery patients with >3 months of documented AF were randomized to surgery with or without adjunct maze or similar AF ablation between 2009 and 2014. Primary outcomes were SR restoration at 1 year and quality-adjusted life years at 2 years. Secondary outcomes included SR at 2 years, overall and stroke-free survival, medication, QoL, cost-effectiveness and safety.ResultsMore ablation patients were in SR at 1 year [odds ratio (OR) 2.06, 95% confidence interval (CI) 1.20-3.54; P = 0.009]. At 2 years, the OR increased to 3.24 (95% CI 1.76-5.96). Quality-adjusted life years were similar at 2 years (ablation - control -0.025, P = 0.6319). Significantly fewer ablation patients were anticoagulated from 6 months postoperatively. Stroke rates were 5.7% (ablation) and 9.1% (control) (P = 0.3083). There was no significant difference in stroke-free survival [hazard ratio (HR) = 0.99, 95% CI 0.64-1.53; P = 0.949] nor in serious adverse events, operative or overall survival, cardioversion, pacemaker implantation, New York Heart Association, EQ-5D-3L and SF-36. The mean additional ablation cost per patient was £3533 (95% CI £1321-£5746). Cost-effectiveness was not demonstrated at 2 years.ConclusionsAdjunct AF surgery is safe and increases SR restoration and costs but not survival or QoL up to 2 years. A continued follow-up will provide information on these outcomes in the longer term.Study registrationISRCTN82731440 (project number 07/01/34).

Dataset Information

Implementation of the graduated compression as an adjunct to pharmaco-thromboprophylaxis in surgery trial results across the UK.

Objectives

Method

Results

Conclusions

Publications

Implementation of the graduated compression as an adjunct to pharmaco-thromboprophylaxis in surgery trial results across the UK.

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