Transcript The CLOTS study

CLOTS 3
Multicentre randomised trial to evaluate
Intermittent Pneumatic Compression
in
patients with acute stroke
Martin Dennis
on behalf
of
The CLOTS trials collaboration
Venous thromboembolism
after stroke
PE
DVT 20%
5% symptomatic
PE 10% on screening MRI
Diagnosed in <3%
Background
• Graduated compression stockings
– reduce the risk of DVT in surgical patients
– do not reduce risk of DVT in stroke (CLOTS 1)
• Intermittent Pneumatic Compression
– reduce the risks of DVT in surgical patients
– not adequately tested in stroke or medical patients
Research Question
Does IPC reduce the frequency of DVT
after stroke?
CLOTS 3
Immobile Stroke patient
Day 0-3 of admission
Routine care
& IPC
Routine care
& No IPC
Duplex of both legs
at 7-10 days
Duplex of both legs
at 25-30 days
6 months follow up
CLOTS 3 - Conduct
• 2876 enrolled by 105 centres in UK
– Dec 2008 to Sept 2012
• Excellent balance for all baseline variables
& post enrolment anti-thrombotics
CLOTS 3 – Efficacy
Primary outcome
IPC
20
%
15
P=0.001
10
12.1
8.5
5
0
Proximal
DVT
No IPC
Probability of Death within 6 months
Cumulative Hazard
No IPC
IPC
Hazard Ratio = 0.86 (95%CI 0.73 - 0.99) p=0.042
Survival time (days)
Conclusions
• IPC is feasible and safe
• IPC is an effective form of VTE
prophylaxis NNT = 28 for proximal DVT
• It probably improves overall survival
NNT~ 43 for death in 30 days
• Effective in ischaemic & haemorrhagic
stroke
More details available
Expedited publication today at
http://www.thelancet.com/