stroke treatment
- From: MarilynMann <mannm@xxxxxxxxxxx>
- Date: Wed, 10 Oct 2007 17:18:36 -0700
The Lancet Neurology Early Online Publication, 10 October 2007
Lancet Neurology DOI:10.1016/S1474-4422(07)70250-8
Fast assessment of stroke and transient ischaemic attack to prevent
early recurrence (FASTER): a randomised controlled pilot trial
James Kennedy FRCPC a, Michael D Hill FRCPC b c d, Karla J
Ryckborst BA b, Michael Eliasziw PhD b d, Andrew M Demchuk FRCPC
b and Alastair M Buchan FMedSci a , for the FASTER
Investigators
‡Members are listed at end of report
Summary
Background
Patients with transient ischaemic attack (TIA) or minor stroke are at
high immediate risk of stroke. The optimum early treatment options for
these patients are not known.
Methods
Within 24 h of symptom onset, we randomly assigned, in a factorial
design, 392 patients with TIA or minor stroke to clopidogrel (300 mg
loading dose then 75 mg daily; 198 patients) or placebo (194
patients), and simvastatin (40 mg daily; 199 patients) or placebo (193
patients). All patients were also given aspirin and were followed for
90 days. Descriptive analyses were done by intention to treat. The
primary outcome was total stroke (ischaemic and haemorrhagic) within
90 days. Safety outcomes included haemorrhage related to clopidogrel
and myositis related to simvastatin. This study is registered as an
International Standard Randomised Controlled Trial (number 35624812)
and with ClinicalTrials.gov (NCT00109382).
Findings
The median time to stroke outcome was 1 day (range 0–62 days). The
trial was stopped early due to a failure to recruit patients at the
prespecified minimum enrolment rate because of increased use of
statins. 14 (7·1%) patients on clopidogrel had a stroke within 90 days
compared with 21 (10·8%) patients on placebo (risk ratio 0·7 [95% CI
0·3–1·2]; absolute risk reduction −3·8% [95% CI −9·4 to 1·9]; p=0·19).
21 (10·6%) patients on simvastatin had a stroke within 90 days
compared with 14 (7·3%) patients on placebo (risk ratio 1·3 [0·7–2·4];
absolute risk increase 3·3% [−2·3 to 8·9]; p=0·25). The interaction
between clopidogrel and simvastatin was not significant (p=0·64). Two
patients on clopidogrel had intracranial haemorrhage compared with
none on placebo (absolute risk increase 1·0% [−0·4 to 2·4]; p=0·5).
There was no difference between groups for the simvastatin safety
outcomes.
Interpretation
Immediately after TIA or minor stroke, patients are at high risk of
stroke, which might be reduced by using clopidogrel in addition to
aspirin. The haemorrhagic risks of the combination of aspirin and
clopidogrel do not seem to offset this potential benefit. We were
unable to provide evidence of benefit of simvastatin in this setting.
This aggressive prevention approach merits further study.
Affiliations
a. Acute Stroke Programme, Nuffield Department of Clinical Medicine,
University of Oxford, Oxford, UK
b. Department of Clinical Neuroscience, University of Calgary,
Calgary, Canada
c. Department of Medicine, University of Calgary, Calgary, Canada
d. Department of Community Health Sciences, University of Calgary,
Calgary, Canada
Correspondence to: Alastair M Buchan, Acute Stroke Programme, Nuffield
Department of Clinical Medicine, Level 7, John Radcliffe Hospital,
Oxford OX9 3DU, UK
* * *
The Lancet Early Online Publication, 9 October 2007
The Lancet DOI:10.1016/S0140-6736(07)61448-2
Articles
Effect of urgent treatment of transient ischaemic attack and minor
stroke on early recurrent stroke (EXPRESS study): a prospective
population-based sequential comparison
Prof Peter M Rothwell FRCP a , Matthew F Giles MRCP a, Arvind
Chandratheva MRCP a, Lars Marquardt MD a, Olivia Geraghty MRCP
a, Jessica NE Redgrave MRCP a, Caroline E Lovelock FRACP a, Lucy
E Binney BMBCh a, Linda M Bull RGN a, Fiona C Cuthbertson MCSP
a, Sarah JV Welch RGN a, Shelley Bosch a, Faye Carasco-Alexander
MSc a, Louise E Silver MSc a, Sergei A Gutnikov DPhil a and
Ziyah Mehta DPhil a, on behalf of the Early use of Existing
Preventive Strategies for Stroke (EXPRESS) study
Summary
Background
The risk of recurrent stroke is up to 10% in the week after a
transient ischaemic attack (TIA) or minor stroke. Modelling studies
suggest that urgent use of existing preventive treatments could reduce
the risk by 80–90%, but in the absence of evidence many health-care
systems make little provision. Our aim was to determine the effect of
more rapid treatment after TIA and minor stroke in patients who are
not admitted direct to hospital.
Methods
We did a prospective before (phase 1: April 1, 2002, to Sept 30, 2004)
versus after (phase 2: Oct 1, 2004, to March 31, 2007) study of the
effect on process of care and outcome of more urgent assessment and
immediate treatment in clinic, rather than subsequent initiation in
primary care, in all patients with TIA or minor stroke not admitted
direct to hospital. The study was nested within a rigorous population-
based incidence study of all TIA and stroke (Oxford Vascular Study;
OXVASC), such that case ascertainment, investigation, and follow-up
were complete and identical in both periods. The primary outcome was
the risk of stroke within 90 days of first seeking medical attention,
with independent blinded (to study period) audit of all events.
Findings
Of the 1278 patients in OXVASC who presented with TIA or stroke (634
in phase 1 and 644 in phase 2), 607 were referred or presented direct
to hospital, 620 were referred for outpatient assessment, and 51 were
not referred to secondary care. 95% (n=591) of all outpatient
referrals were to the study clinic. Baseline characteristics and
delays in seeking medical attention were similar in both periods, but
median delay to assessment in the study clinic fell from 3 (IQR 2–5)
days in phase 1 to less than 1 (0–3) day in phase 2 (p<0·0001), and
median delay to first prescription of treatment fell from 20 (8–53)
days to 1 (0–3) day (p<0·0001). The 90-day risk of recurrent stroke in
the patients referred to the study clinic was 10·3% (32/310 patients)
in phase 1 and 2·1% (6/281 patients) in phase 2 (adjusted hazard ratio
0·20, 95% CI 0·08–0·49; p=0·0001); there was no significant change in
risk in patients treated elsewhere. The reduction in risk was
independent of age and sex, and early treatment did not increase the
risk of intracerebral haemorrhage or other bleeding.
Interpretation
Early initiation of existing treatments after TIA or minor stroke was
associated with an 80% reduction in the risk of early recurrent
stroke. Further follow-up is required to determine long-term outcome,
but these results have immediate implications for service provision
and public education about TIA and minor stroke.
Affiliations
a. Stroke Prevention Research Unit, University Department of Clinical
Neurology, Radcliffe Infirmary, Oxford, UK
Correspondence to: Prof Peter M Rothwell, Stroke Prevention Research
Unit, University Department of Clinical Neurology, Radcliffe
Infirmary, Woodstock Road, Oxford OX2 6HA, UK
http://www.medicalnewstoday.com/articles/85062.php
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