Summary
Evidence Report/Technology Assessment: Number 127
Acute Stroke: Evaluation and Treatment
Under its Evidence-based Practice Program, the Agency for Healthcare Research and Quality (AHRQ) is developing scientific information for other agencies and organizations on which to base clinical guidelines, performance measures, and other quality improvement tools. Contractor institutions review all relevant scientific literature on assigned clinical care topics and produce evidence reports and technology assessments, conduct research on methodologies and the effectiveness of their implementation, and participate in technical assistance activities.
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Introduction / Methods / Results / Discussion / Availability of Full Report / References
Authors: Sharma M, Clark H, Armour T, Stotts G, Coté R, Hill MD, Demchuck AM, Moher D,
Garritty C, Yazdi F, Lumely-Leger K, Murdock M, Sampson M, Barrowman N, Lewin G.
Introduction
Stroke defines an acute vascular event in the brain and is a leading cause
of death and disability. Ischemic stroke results from decreased
blood flow to a portion of the brain with consequent cell death. Hemorrhagic
stroke, on the other hand, is a result of bleeding into the brain. Ischemic
stroke is far more common and is potentially treatable with thrombolytic therapy. While
effective, the wide application of this therapy has been hampered by restrictive
selection criteria based on time since onset of symptoms. Successful
treatment requires a system capable of rapidly identifying and evaluating prospective
candidates.
In this context, use of community education, specific
ED protocols and designated treatment centers may demonstrate some advantages. Evidence
is emerging that patient selection by time since stroke onset, imaging characteristics,
and intra-arterial treatment may increase the probability of recanalisation
of occluded vessels. Normalization of serum glucose, acute blood
pressure management and surgical extraction of intracerebral clot may be of
benefit in some circumstances.
The purpose of this report is to systematically review the available literature
in the field of acute stroke evaluation and treatment. The University
of Ottawa Evidence-based Practice Center (UO-EPC) task involving the following
three areas:
- What interventions in acute stroke (<24 hours from onset) are effective in reducing morbidity and mortality.
- How safety and effectiveness of these interventions vary by timing in relation to onset of symptoms.
- Determine what the evidence is that specific systems of care improve outcomes of acute stroke.
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Methods
The databases searched were MEDLINE® (1966 to April Week 4 2004), Embase® (last
6 months) and CINAHL (1982 to April Week 5 2004) using the OVID interface. Also
searched were the Stroke Trials Directory, the Cochrane Stroke Group Registry,
conference proceedings from the 28th International
Stroke Conference 2003 (Stroke, Feb 2004) and the American Academy of Neurology Annual Meeting (published in Neurology). The
Effective Practices and Organization of Care (EPOC) registry was searched by
the Cochrane review group.
All results of searches for evidence were provided to two reviewers for assessment. All
studies were screened by both reviewers by reviewing the bibliographic records,
and when meeting inclusion criteria, the subsequent full-text of the record. If
the reviewers did not agree in finding at least one unequivocal reason for
excluding the study, it was entered into the next phase of the review. The
reasons for exclusion were noted using a modified QUOROM format.
Two reviewers independently abstracted the contents
of each included study using an electronic Data Abstraction form developed
especially for this review. Data abstracted included the study
and population characteristics, intervention characteristics and relevant outcomes
of included studies.
Attempts were made to minimize, and where not possible, explain statistical
and clinical heterogeneity. Pooled estimates were only calculated
if clinically and statistically appropriate. In situations where
it was felt to that quantitative synthesis could not be performed, a qualitative
narrative synthesis was conducted.
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Results
Intervention A
Does surgery impact the outcome in patients
with acute intracerebral hematoma?
Twenty-three studies were identified by our search. Meta-analysis
was conducted on four studies. The four trials had a total of
246 subjects. The pooled estimate favored treatment; however,
the confidence interval crossed the null (OR=0.24] 0.02, 3.03]). A
meta-analysis for the outcome of death produced similar results (OR=0.62] 0.34,
1.13]). The meta-analysis was repeated including the study published
after the period included in the search strategy. This study
had significantly greater numbers than the other included studies; however,
the conclusion of the meta-analysis was not altered. Once again,
the odds ratio for death had a point estimate favoring treatment; however,
confidence interval clearly crossed the null (OR=0.81] 0.54, 1.22]). Moderate
heterogeneity was noted.
Intervention B
Does antihypertensive treatment reduce
stroke-related mortality and disability in patients with acute ICH?
Six studies were identified that investigated antihypertensive
therapy for ICH. Four of these were non comparative case series
and thus were excluded from our review. Two unique studies met
eligibility criteria and were pre- and post-designs. Neither
study commented on outcomes of death or disability. One suggested that cerebral
perfusion pressure was not altered with antihypertensive therapy.
Intervention C
Does intra-arterial (IA) thrombolysis
reduce stroke-related mortality and disability in adults with acute ischemic
stroke?
Of the 37 studies identified by the search strategy, five unique publications
met criteria for inclusion. Two studies could be combined with
the pooled estimates for death and disability and death favoring treatment
with a confidence interval which crossed the null in both cases: death and
disability (OR=0.55 [0.29, 1.16]), death (OR=0.78 [0.42, 1.47]). Thus,
while the pooled estimates for these outcomes are not statistically significant
the possibility of substantial benefit from intra-arterial therapy cannot be
excluded. A pooled estimate of the impact on disability alone
could not be obtained from the available data. A single study1 suggests
an absolute improvement in the proportion of subjects with a mRS score < or
= 2 of 15%. The odds ratio for this outcome was 2.13 (1.02, 4.42).
Intervention D
Does treatment to normalize blood glucose
levels reduce stroke-related mortality and disability in adults with acute
stroke?
No studies were identified which specifically addressed
this question. Two unique publications demonstrated the feasibility
of reduction in serum glucose levels but were not designed to measure clinical
outcome.
Intervention E
Does mechanical clot disruption reduce
stroke-related mortality and disability in adults with acute ischemic stroke?
Ten studies were identified by the search criteria
with one, which fell outside the search dates, provided by an expert. Of
these, two unique RCTs met the criteria for inclusion. Both evaluated
the effect of ultrasound enhanced thrombolysis in MCA occlusion. Primary
end points differed but there the treatment effect in both studies favored
intervention.
Intervention F
Is the effectiveness and safety of thrombolytic
therapy for adults with acute ischemic stroke affected by time from onset to
treatment?
No single study has attempted to investigate the impact of timing on thrombolysis
treatment outcome however five unique publications examining treatment outcomes
across relevant time windows were included.2
Studies examining enrollment of patients 3 to 5 hours after stroke onset and
0 to 6 hours after onset did not show treatment benefit.2,3 Reanalysis
of the NINDS trial data4 suggested improved functional outcome for
the 0-90 minute stratum as compared with the 91-180 minute interval. A
patient level meta-analysis of six trials of tPA treatment for ischemic stroke
with treatment windows between 0 and 6 hours was identified which examined
the relationship between onset to treatment time and outcome.5 A
clear association was found between onset to treatment time and outcome. The
odds ratio for favorable outcome with tPA treatment in the 0 to
90 minute interval was 2.81 (95% CI 1.75-4.50). This decreased
to 1.15 (0.90-1.47) in the 271 to 360 minute interval. No increase
in mortality was noted until the 271-360 minute interval.
Intervention G
Do pretreatment CT scoring systems affect
the safety and efficacy of thrombolytic therapy for acute ischemic stroke?
Two unique studies were included in this analysis.6 Prospective
evaluation of CT scoring systems was not available, and both included studies
are evaluations of CTs conducted during the course of prospective trials of
thrombolysis in stroke. Analysis of CT scans from patients in
the NINDS trial demonstrates that while early infarct changes are common, they
correlate poorly with outcome.6 A weak association
between early CT changes and outcome was noted in the PROACT 2 trial.7
Intervention H
Do pretreatment MRI scoring systems affect
the safety and efficacy of thrombolytic therapy for acute ischemic stroke?
Six
studies were identified that addressed the effectiveness of an MRI scoring
system for ischemic stroke. One multiple prospective cohort
study8 and one single prospective cohort study,9 published in 2002 and 2003, were included
in our review. Three non comparative case series reports10-12 and one case study were excluded
for level of evidence.13 Neither of the included
studies used MRI measures prospectively to make decisions on thrombolysis.
Both, however, provided correlations with surrogate measures which may be
useful in clinical decision making. Recanalisation and initial
DWI lesions were found to correlate with clinical outcome and infarct volume
at 60 days. In addition, in patients treated with intravenous tPA,
time to peak was correlated with recanalisation at day 1. Thirteen
of 15 patients (93%) whose baseline time-to-peak was less than or equal to
36.9 milliseconds recanalized within the first day versus 5 of 15 patients
(35.7%) whose time-to-peak was greater than 36.9 milliseconds.9 Suarez and colleagues8 reported a single-center cohort in which
the presence of cortical infarct on MRI was used to select patients for IA
treatment following IV treatment. MR imaging added 17 minutes
to the treatment protocol and thus was felt to be feasible but due to the
absence of a comparison group no comment can be made about marginal effectiveness
over current treatment protocols.
Intervention I
Do CT perfusion/angiography affect the
safety and efficacy of thrombolytic therapy for acute ischemic stroke?
Three
studies (four publications) examining CT perfusion/angiography for ischemic
stroke were identified.14-17 One potentially relevant
trial14,15 was published in abstract
form and the authors were contacted to determine if subsequent articles were
published. These were excluded following full text screening. Study
design could not be determined in two publications and were excluded for
level of evidence.18,19 One single retrospective
cohort study16 and one case-control study,17 published in 2001 and 2004, respectively
were included in our review.
The
hyperdense MCA sign (HCMAS) was evaluated in a small cohort of patients treated
with either IV or IA Thrombolysis.17 The hyperdense MCA sign
was associated with a greater probability of recovery with IA than intravenous
treatment (37% versus 13%). This observational data17 suggests that this sign may be used as
a tool to triage patients between intravenous and IA treatment. There
is a higher probability that proximal large vessel occlusion as reflected
by this sign may be associated with worse outcomes intravenously. This
observation will require testing in a prospective study.
Kirpatrick
and colleagues16 reported on a retrospective cohort of
51 patients from a single center between 1997 and 2000. A CT angiogram showing patent vessels was associated
with a rate of infarct of 7 percent (1/14 patients) while CT angiogram showing occlusion
had an infarct rate of 60 percent (6/10) (p=0.008).
Intervention J
Are community education programs effective in reducing
stroke-related disability and mortality?
One
controlled clinical trial,20 six before-after studies,21-26 and one study for which study
design could not be determined,27 investigated the use of community education
programs for acute stroke. Subsequently, seven studies were
excluded for level of evidence.21-27 Only one study20 was included for our review. This
study was a controlled clinical trial and was published in 2003.
Morgenstern, et al.20 reported on the third phase of the TLL
Temple Foundation Stroke Project. Target behaviors of lay community
(the "at-risk group"), EMS, ED physicians, neurologists, and community
primary care providers were identified, and educational and
infrastructure changes were initiated. A portion of the multilevel
intervention public service announcements were created using local role models,
volunteers were trained to take the message to community groups, and educational
pamphlets were distributed.
Intervention K
Are designated centers effective in reducing
stroke-related disability and mortality?
It
has been hypothesized that to increase utilization of thrombolytics, a dedicated
stroke center strategy should be developed.28 No studies meeting eligibility
criteria for investigating the use of designated centers as defined by the
Brain Attack Coalition were identified by our searches.28 The studies we included
were felt to most closely resemble the model of a designated stroke center
as defined by the Brain Attack Coalition and detailed by Alberts, et al. (2000)
in their recommendations for the establishment of primary stroke centers.28 Both studies were single
prospective cohort designs and were published between 2000 and 2003.
Hill, et al.29 reported
on building a "brain attack" team to administer thrombolytic therapy to patients
with acute stroke and on their initial experience with IV-administered thrombolytics. A
complex system of interventions involving all levels of the system involved
in acute stroke care was reorganized. Over the course of the
study period improvements in certain parameters were noted. Overall,
symptom onset to treatment time was significantly decreased from a mean of
167.8 minutes to 147.4 minutes.29
Lattimore and colleagues reported on a similar
process of designation and implementation of processes to enhance thrombolysis. An
increase in the proportion of ischemic stroke treated with tPA from
1.5 percent to 10.5 percent was noted30.
Intervention L
Are ED protocols for the management of acute stroke
effective in reducing disability and mortality?
Our
search identified one case-control study,31 two single prospective cohort studies,32,33 two single retrospective
cohort studies,34,35 two non-comparative case
series studies,36,37 and two studies whose design
could not be determined.38,39 The case-control and non-comparative
studies were excluded for level of evidence. Four studies,
published between 1999 and 2003, examining the effect of ED protocols for
management of acute stroke met our eligibility criteria and were included
in our final analyses.32-35
Smith, et al.34 reported on the establishment of ED procedures
and training established for the purposes of thrombolytic treatment. The
program relied on ED physicians, with neurology consultation, as primarily
responsible for treatment. Treatment times in this model compared
favorably with those in models involving comprehensive stroke team response. A
similar effort is reported by Akins 35. Similar treatment times
were achieved when ED physicians treated as compared to consulting neurologists. The
rate of protocol violations was initially higher in the ED group (30% vs 5%)
than the neurologist group but was reduced by staff education. Jahnke, et al.33 described a comprehensive stroke pathway implemented
in the ED. Following this intervention the stroke pathway was initiated in
97 percent of patients as opposed to 40 percent prior. The door to needle time
decreased from a mean of 111 minutes to 77 minutes.
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Discussion
Currently, available data do not support a role
for surgery in the treatment of acute intracerebral hemorrhage. Results,
however, do not preclude benefit from surgery which involves modalities other
than those studied in the acute trials (e.g., minimally invasive
technologies) or treatment of hemispheric hematoma at very early timeframes. Further,
the available literature did not comment on cerebellar hematoma and thus this
analysis does not apply to infratentorial hemorrhage.
In spite of potential importance, availability
of therapy and ease of administration of antihypertensive agents, very little
data exists to suggest that their use is of benefit (or results in harm) in
the setting of acute ICH. A similar situation exists regarding
glucose management for acute ischemic stroke. Further studies
are required in both these areas.
IV thrombolysis with tPA is effective and efficacious for acute
ischemic stroke within 3 hours of symptom onset. The effectiveness
is strongly linked to time since onset of symptoms with shorter times demonstrating
significantly better outcomes. Patient level meta-analysis
suggests that treatment may be effective up to 270 minutes with treatment
increasing the odds of death beyond 270 minutes. Further work
is needed to define the risks and benefits of treatment outside the 3 hour
window prior to advocating widespread use in these patients. Intra-arterial
therapy remains an option for a subgroup of patients with large vessel occlusions
principally in the middle cerebral artery distribution. The
evidence for this intervention, however, remains less robust than for IV
therapy. Limited data is available regarding patient characteristics
predicting outcome. The system changes required to ensure prompt
delivery of appropriate therapy are complex and operate on multiple levels. In
spite of their critical role, little data exists regarding the efficacy of
these interventions and, in particular, the relative efficacy of various
components with regard to patient outcomes.
Ultrasound for enhancement of thrombolysis in the
setting of MCA occlusion has suggested efficacy in two studies and a definitive
trial to demonstrate the benefit and risks is required.
CT and MRI imaging for patient selection and prediction
of outcome in thrombolysis has yet to be prospectively evaluated. The
two included CT studies6,7 differ in onset to evaluation
time with only a weak correlation between CT changes and outcome seen in the
trial enrolling patients from 0-6 hours. Neither study quantified
CT changes. The ASPECTS score is an easily quantifiable scoring system for
early infarct changes.40 Retrospective evaluation
of the ASPECTS score suggests that values below 7 correlate with poorer outcomes. As
CT is widely available this system deserves further exploration. Additional
information relevant to treatment decisions may be provided by CT angiography. Occlusion
of proximal vessels is associated with higher rates of infarction and thus
may influence treatment modalities.
MRI DWI lesions correlate with the presence of infarcts
in small cohorts of patients and time to peak measures on early scans may correlate
with recanalization after IV tPA treatment. These
findings require reproduction and further evaluation. The multiplanar
abilities and potential for acquisition of multiple parameters are potentially
attractive features of this modality and may assist in selecting patients with
a greater ratio of benefit to harm in intravenous and intra-arterial treatment
paradigms.
The narrow time window for thrombolysis in acute stroke
as well as the relationship between time to treatment and outcome has led to
the exploration of a number of strategies for optimization of outcomes. Community
education programs regarding the symptoms of stroke have not been independently
evaluated but rather studied in the context of more comprehensive system changes. Thus,
it is unclear if these programs are effective in improving patient outcomes. Further
exploration is also required regarding the content and targeting of such programs. Descriptions
of designated treatment centers have shown the feasibility of this approach
but an evaluation of published criteria for and marginal effectiveness of such
designations remains to be performed.
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Availability of Full Report
The full evidence report from which this summary was
taken was prepared for the Agency for Healthcare Research and Quality (AHRQ)
by the University of Ottawa Evidence-based Practice Center, under Contract
No. 290-02-0021. Printed copies may be obtained free of charge from
the AHRQ Requesters Clearinghouse by calling 800-358-9295. Requesters should
ask for Evidence Report/Technology Assessment No. 127, Acute Stroke: Evaluation and Treatment.
The Evidence Report is also online on the National Library of Medicine Bookshelf or can be downloaded as a PDF File (1.5 MB). PDF Help.
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AHRQ Publication Number 05-E023-1
Current as of July 2005
Internet Citation:
Sharma M, Clark H, Armour T, et al. Acute Stroke: Evaluation and Treatment. Summary, Evidence Report/Technology Assessment: Number 127. AHRQ Publication Number 05-E023-1, July 2005. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/clinic/epcsums/acstrokesum.htm
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