CLOTS 3 study shows sequential compression sleeves reduce deep vein thrombosis events in immobile stroke patients

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Intermittent pneumatic compression, in which thigh-length sleeves are used to compress the veins in the legs, mimicking the effects of walking, is an effective method of reducing the risk of deep vein thrombosis and possibly improving survival patients who are immobile after stroke, the study reveals.

The results of the CLOTS 3 trial were presented at the European Stroke Conference (28–31 May, London, UK) by Martin S Dennis, Division of Clinical Neurosciences, University of Edinburgh, Scotland, and also published in The Lancet.

The new study showed a 29.9% decrease in the development of proximal deep vein thrombosis in immobile stroke patients who received intermittent pneumatic compression using the Kendall SCD system (Covidien), which delivers sequential, circumferential, gradient compression through thigh-length sleeves. Compared to the routine care group, the intermittent pneumatic compression group also showed a 14% mortality risk reduction (p=0.042) during the first six months after hospital admission for stroke.

CLOTS 3 was a multicentre, randomised, controlled study that evaluated the effectiveness of intermittent pneumatic compression in reducing the risk of deep vein thrombosis and death in stroke patients. Between December 2008, and September 2012, 2,876 patients (median age of 76 years) who were within three days of hospital admission for a stroke were enrolled in 94 centres in the UK. They were randomly assigned to wearing the compression sleeves or not. For the study, the thigh-length sleeves were worn day and night for up to 30 days or until discharge, death, or mobility (defined as when the patient could walk to the bathroom unaided). The average duration of use was 12 days.

Dennis reported that the primary outcome of deep venous thrombosis in the proximal veins within 30 days was reduced by an absolute 3.6% in the intermittent compression group. An associated commentary (S M Stevens and S C Wolle), also published in TheLancet, said: “Although the trial was not powered to show a significant reduction in either pulmonary embolism or death, the intermittent pneumatic compression group appeared to be favoured compared with the no intermittent pneumatic compression group. Skin breaks occurred more frequently in the intermittent pneumatic compression group than in the no intermittent pneumatic compression group, and a non­significant increase in falls with injury was noted in the intermittent pneumatic compression group.”

“At last we have a simple, safe and affordable treatment that reduces the risk of deep vein thrombosis and even appears to reduce the risk of dying after a stroke,” said Dennis. “We believe that the national guidelines need to be revised in the light of our findings. The current guidelines have suggested that intermittent pneumatic compression should be considered only where blood-thinning injections are unsuccessful or inappropriate, but this research suggests that intermittent pneumatic compression should be used in all patients at high risk of deep vein thrombosis.”

The trial was funded by the National Institute of Health, the Health Technology Assessment program and the Chief Scientist Office Scotland.