Abstract

The CLOTS 3 trial showed that intermittent pneumatic compression (IPC) reduced the risk of DVT and improved survival after stroke. To provide additional information which may help clinicians target IPC on the most appropriate patients by exploring the variation in its effects on subgroups defined by predicted prognosis. A multicentre, parallel group, randomized trial enrolled immobile acute stroke patients and allocated them to IPC or no IPC. The primary outcome was proximal DVT at 30 days. Secondary outcomes at six-months included survival, disability, quality of life, and hospital costs. We stratified patients into quintiles according to their predicted prognosis at randomization, based on the Six Simple Variable model. Between December 2008 and September 2012, we enrolled 2876 patients in 94 UK hospitals. Patients with the best predicted outcome had the lowest absolute risk of proximal DVT (6·7%) and death by six-months (9·3%). Allocation to IPC had little effect on DVT, survival, disability, quality of life, hospital length of stay, or costs. In patients with the worst predicted outcomes, the overall risk of DVT and death was 16·0% and 51·3%, respectively. IPC reduced DVT (odds reduction 34%) and improved survival 17% and significantly increased length of stay and hospital costs. In the three intermediate quintiles, IPC reduced the odds of DVT (35-43%) and improved survival (11-13%). Disability and quality of life at six-months depended on baseline severity but was not influenced significantly by IPC. IPC appears to reduce the risk of DVT and probably improves survival in all immobile stroke patients, other than the fifth with the best prognosis. It therefore seems reasonable to recommend that IPC should be considered in all immobile stroke patients, but that the final decision should be based on a judgment about the individual's prognosis. In some, their prognosis for survival with an acceptable quality of life will be so poor that use of IPC might be considered futile, while at the other end of the spectrum, patients' risk of DVT, and of dying from VTE, may not be high enough to justify the modest cost and inconvenience of IPC use.

Highlights

  • Venous thromboembolism (VTE) is common after stroke, causes significant morbidity, may delay hospital discharge, increases healthcare costs, and has been estimated to account for up to a quarter of all deaths after stroke [1]

  • The CLOTS 3 trial showed that intermittent pneumatic compression (IPC) applied to the legs of immobile acute stroke patients reduces the odds of proximal DVT by about a third and improves survival over the first six-months [2]

  • Using an ordinal regression analysis adjusted for baseline variables, there were no statistically significant treatment differences in the distribution of Oxford handicap scale (OHS) between those treated with IPC and the untreated group, either overall or within any quintile

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Summary

Introduction

Venous thromboembolism (VTE) is common after stroke, causes significant morbidity, may delay hospital discharge, increases healthcare costs, and has been estimated to account for up to a quarter of all deaths after stroke [1]. Implemented in stroke units throughout the United Kingdom [5]. Those writing these guidelines questioned whether IPC should be targeted on specific groups of immobile stroke patients. It has been suggested that trialists should report the heterogeneity of treatment effects in groups defined by more than one characteristic as a way of providing decision makers with information which might inform their decisions about which patients are most likely to benefit from an intervention [6]. We aimed to establish whether there were categories of immobile stroke patients, based on their predicted prognosis which takes account of six variables at baseline, who may potentially gain more or less from IPC, and in whom IPC might be more or less cost-effective. The CLOTS 3 trial showed that intermittent pneumatic compression (IPC) reduced the risk of DVT and improved survival after stroke.

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