Downloaded from http://ebn.bmj.com/ on January 15, 2017 - Published by group.bmj.com
Adult nursing external validity, with trial patients characteristics very similar to immobile patients with stroke recorded in the Scottish Stroke Care Audit.
Randomised controlled trial
Intermittent pneumatic compression is effective in reducing proximal DVT 10.1136/eb-2015-102265 Kwok Ming Ho,1,2,3 Yusra Harahsheh1 1
Department of Intensive Care Medicine, Royal Perth Hospital; 2School of Population Health, University of Western Australia; 3School of Veterinary & Life Sciences, Murdoch University Correspondence to: Dr Kwok Ming Ho, Department of Intensive Care Medicine, Royal Perth Hospital, University of Western Australia and Murdoch University, Perth, WA 6000, Australia; [email protected]. gov.au
Commentary on: Dennis M, Sandercock P, Graham C, et al. The Clots in Legs Or sTockings after Stroke (CLOTS) 3 trial: a randomised controlled trial to determine whether or not intermittent pneumatic compression reduces the risk of post-stroke deep vein thrombosis and to estimate its cost-effectiveness. Health Technol Assess 2015;19:1–90.
Implications for practice and research ▪ Intermittent pneumatic compression (IPC) is effective in reducing proximal deep vein thrombosis and should be used for all immobile patients with stroke, unless cost is a major concern. ▪ The cost-effectiveness of IPC in different types of medical patients remains uncertain; future randomised controlled trials on IPC should be powered by cost-effectiveness.
Context Venous thromboembolism (VTE) is a common complication in hospitalised patients, and is associated with significant morbidity and mortality. Although pharmacological thromboprohylaxis is effective in reducing VTE, many patients with stroke are considered to have contraindications to this treatment due to a potential increased risk of haemorrhagic transformation or enlargement of haematoma. As omission of thromboprophylaxis in seriously ill patients is associated with increased mortality,1 mechanical VTE prophylaxis becomes an important option. Previous trials failed to confirm the efficacy of graduate compression stockings (GCS) in reducing VTE in patients with stroke2; consequently, whether or not intermittent pneumatic compression (IPC) can reduce VTE in patients with stroke is an important clinical question.
Methods
Findings Using IPC in patients with stroke was effective in reducing incidence of lower limb DVT compared to standard care without IPC (8.5% vs 12.1%, respectively); the estimated cost to prevent one proximal DVT was £1800, assuming cost per pair of compression sleeves was £25, with each patient requiring 2.5 pairs. There was no statistically significant difference in crude mortality at 6 months; but after adjusting for baseline differences, IPC was associated with a 14% relative risk reduction in mortality at 6 months.
Commentary Venous stasis is a major factor in the pathogenesis of VTE, hence, immobile patients with stroke are at high-risk of developing VTE. The CLOTS3 study confirmed that (1) proximal VTE was common in immobile patients with stroke (12.1% in the control group), (2) antiplatelet agent alone was inadequate in preventing proximal DVT (almost all patients in the CLOTS3 trial were treated with an antiplatelet agent) and (3) IPC was effective in reducing DVT even when patients were treated with pharmacological thromboprophylaxis (about half of the study patients received pharmacological thromboprophylaxis)—consistent with results of a recent meta-analysis on IPC including both medical and surgical patients.3 The CLOTS3 trial has, however, failed to confirm IPC’s costeffectiveness despite a suggestion it could reduce mortality. There are two possible explanations. First, VTE was more common among the more severe patients with stroke, with significant disability resulting in prolonged immobilisation. Any benefits derived from VTE reduction in such patients would not be translated into measurable improvement in quality-of-life and hospitalisation savings. Second, as routine CDU was performed twice within 30 days after stroke, trial patients would have DVT diagnosed earlier than in real-life situations, resulting in early appropriate treatment before they developed fatal and non-fatal pulmonary embolism. This reduces the power of the study to detect the secondary end points, including cost-effectiveness of IPC. Since IPC is safe, relatively cheap and more effective than other nonpharmacological means to prevent VTE, including early mobilisation and GCS,2 4 IPC should be seriously considered as an important part of a multimodality approach to prevent VTE in immobile patients with stroke.5 Correction notice This article has been corrected since it was published Online First. The author affiliations have been corrected. Competing interests None declared.
References
The CLOTS3 trial was a multicentre, parallel-group, randomised controlled trial (RCT) assessing the effectiveness of IPC on immobile patients with stroke, designed with 90% power to detect a 4% difference in incidence of proximal deep vein thrombosis (DVT) within 30 days. This was a well-designed study, including 2876 patients from 94 UK hospitals. Internal validity was achieved by adequate allocation concealment, and primary outcome was determined by two Compression Duplex Ultrasonography (CDU) performed by ultrasonographers, blinded to treatment allocation. The latter was important because it is impossible to blind the use of IPC to the treating clinicians. The trial also had good
1. Ho KM, Chavan S, Pilcher D. Omission of early thromboprophylaxis and mortality in critically ill patients: a multicenter registry study. Chest 2011;140:1436–46. 2. CLOTS Trials Collaboration. Effectiveness of thigh-length graduated compression stockings to reduce the risk of deep vein thrombosis after stroke (CLOTS Trial 1): a multicentre, randomised controlled trial. Lancet 2009;373:1958–65. 3. Ho KM, Tan JA. Stratified meta-analysis of intermittent pneumatic compression of the lower limbs to prevent venous thromboembolism in hospitalized patients. Circulation 2013;128:1003–20. 4. Bernhardt J, Langhorne P, Lindley RI, et al., VERT Trial Collaboration Group. Efficacy and safety of very early mobilisation within 24h of stroke onset (AVERT): a randomised controlled trial. Lancet 2015;386:46–55.
Evid Based Nurs April 2016 | volume 19 | number 2 |
47
Downloaded from http://ebn.bmj.com/ on January 15, 2017 - Published by group.bmj.com
Intermittent pneumatic compression is effective in reducing proximal DVT Kwok Ming Ho and Yusra Harahsheh Evid Based Nurs 2016 19: 47 originally published online November 30, 2015
doi: 10.1136/eb-2015-102265 Updated information and services can be found at: http://ebn.bmj.com/content/19/2/47
These include:
References Email alerting service
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This article cites 6 articles, 1 of which you can access for free at: http://ebn.bmj.com/content/19/2/47#BIBL Receive free email alerts when new articles cite this article. Sign up in the box at the top right corner of the online article.
Articles on similar topics can be found in the following collections Adult nursing (57) Venous thromboembolism (30) Stroke (225) Clinical diagnostic tests (111)
Notes
To request permissions go to: http://group.bmj.com/group/rights-licensing/permissions To order reprints go to: http://journals.bmj.com/cgi/reprintform To subscribe to BMJ go to: http://group.bmj.com/subscribe/
Adult nursing external validity, with trial patients characteristics very similar to immobile patients with stroke recorded in the Scottish Stroke Care Audit.
Randomised controlled trial
Intermittent pneumatic compression is effective in reducing proximal DVT 10.1136/eb-2015-102265 Kwok Ming Ho,1,2,3 Yusra Harahsheh1 1
Department of Intensive Care Medicine, Royal Perth Hospital; 2School of Population Health, University of Western Australia; 3School of Veterinary & Life Sciences, Murdoch University Correspondence to: Dr Kwok Ming Ho, Department of Intensive Care Medicine, Royal Perth Hospital, University of Western Australia and Murdoch University, Perth, WA 6000, Australia; [email protected]. gov.au
Commentary on: Dennis M, Sandercock P, Graham C, et al. The Clots in Legs Or sTockings after Stroke (CLOTS) 3 trial: a randomised controlled trial to determine whether or not intermittent pneumatic compression reduces the risk of post-stroke deep vein thrombosis and to estimate its cost-effectiveness. Health Technol Assess 2015;19:1–90.
Implications for practice and research ▪ Intermittent pneumatic compression (IPC) is effective in reducing proximal deep vein thrombosis and should be used for all immobile patients with stroke, unless cost is a major concern. ▪ The cost-effectiveness of IPC in different types of medical patients remains uncertain; future randomised controlled trials on IPC should be powered by cost-effectiveness.
Context Venous thromboembolism (VTE) is a common complication in hospitalised patients, and is associated with significant morbidity and mortality. Although pharmacological thromboprohylaxis is effective in reducing VTE, many patients with stroke are considered to have contraindications to this treatment due to a potential increased risk of haemorrhagic transformation or enlargement of haematoma. As omission of thromboprophylaxis in seriously ill patients is associated with increased mortality,1 mechanical VTE prophylaxis becomes an important option. Previous trials failed to confirm the efficacy of graduate compression stockings (GCS) in reducing VTE in patients with stroke2; consequently, whether or not intermittent pneumatic compression (IPC) can reduce VTE in patients with stroke is an important clinical question.
Methods
Findings Using IPC in patients with stroke was effective in reducing incidence of lower limb DVT compared to standard care without IPC (8.5% vs 12.1%, respectively); the estimated cost to prevent one proximal DVT was £1800, assuming cost per pair of compression sleeves was £25, with each patient requiring 2.5 pairs. There was no statistically significant difference in crude mortality at 6 months; but after adjusting for baseline differences, IPC was associated with a 14% relative risk reduction in mortality at 6 months.
Commentary Venous stasis is a major factor in the pathogenesis of VTE, hence, immobile patients with stroke are at high-risk of developing VTE. The CLOTS3 study confirmed that (1) proximal VTE was common in immobile patients with stroke (12.1% in the control group), (2) antiplatelet agent alone was inadequate in preventing proximal DVT (almost all patients in the CLOTS3 trial were treated with an antiplatelet agent) and (3) IPC was effective in reducing DVT even when patients were treated with pharmacological thromboprophylaxis (about half of the study patients received pharmacological thromboprophylaxis)—consistent with results of a recent meta-analysis on IPC including both medical and surgical patients.3 The CLOTS3 trial has, however, failed to confirm IPC’s costeffectiveness despite a suggestion it could reduce mortality. There are two possible explanations. First, VTE was more common among the more severe patients with stroke, with significant disability resulting in prolonged immobilisation. Any benefits derived from VTE reduction in such patients would not be translated into measurable improvement in quality-of-life and hospitalisation savings. Second, as routine CDU was performed twice within 30 days after stroke, trial patients would have DVT diagnosed earlier than in real-life situations, resulting in early appropriate treatment before they developed fatal and non-fatal pulmonary embolism. This reduces the power of the study to detect the secondary end points, including cost-effectiveness of IPC. Since IPC is safe, relatively cheap and more effective than other nonpharmacological means to prevent VTE, including early mobilisation and GCS,2 4 IPC should be seriously considered as an important part of a multimodality approach to prevent VTE in immobile patients with stroke.5 Correction notice This article has been corrected since it was published Online First. The author affiliations have been corrected. Competing interests None declared.
References
The CLOTS3 trial was a multicentre, parallel-group, randomised controlled trial (RCT) assessing the effectiveness of IPC on immobile patients with stroke, designed with 90% power to detect a 4% difference in incidence of proximal deep vein thrombosis (DVT) within 30 days. This was a well-designed study, including 2876 patients from 94 UK hospitals. Internal validity was achieved by adequate allocation concealment, and primary outcome was determined by two Compression Duplex Ultrasonography (CDU) performed by ultrasonographers, blinded to treatment allocation. The latter was important because it is impossible to blind the use of IPC to the treating clinicians. The trial also had good
1. Ho KM, Chavan S, Pilcher D. Omission of early thromboprophylaxis and mortality in critically ill patients: a multicenter registry study. Chest 2011;140:1436–46. 2. CLOTS Trials Collaboration. Effectiveness of thigh-length graduated compression stockings to reduce the risk of deep vein thrombosis after stroke (CLOTS Trial 1): a multicentre, randomised controlled trial. Lancet 2009;373:1958–65. 3. Ho KM, Tan JA. Stratified meta-analysis of intermittent pneumatic compression of the lower limbs to prevent venous thromboembolism in hospitalized patients. Circulation 2013;128:1003–20. 4. Bernhardt J, Langhorne P, Lindley RI, et al., VERT Trial Collaboration Group. Efficacy and safety of very early mobilisation within 24h of stroke onset (AVERT): a randomised controlled trial. Lancet 2015;386:46–55.
Evid Based Nurs April 2016 | volume 19 | number 2 |
47
Downloaded from http://ebn.bmj.com/ on January 15, 2017 - Published by group.bmj.com
Intermittent pneumatic compression is effective in reducing proximal DVT Kwok Ming Ho and Yusra Harahsheh Evid Based Nurs 2016 19: 47 originally published online November 30, 2015
doi: 10.1136/eb-2015-102265 Updated information and services can be found at: http://ebn.bmj.com/content/19/2/47
These include:
References Email alerting service
Topic Collections
This article cites 6 articles, 1 of which you can access for free at: http://ebn.bmj.com/content/19/2/47#BIBL Receive free email alerts when new articles cite this article. Sign up in the box at the top right corner of the online article.
Articles on similar topics can be found in the following collections Adult nursing (57) Venous thromboembolism (30) Stroke (225) Clinical diagnostic tests (111)
Notes
To request permissions go to: http://group.bmj.com/group/rights-licensing/permissions To order reprints go to: http://journals.bmj.com/cgi/reprintform To subscribe to BMJ go to: http://group.bmj.com/subscribe/
