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Abstract

The increasing prevalence of cerebrovascular diseases has made urgent the need to develop timely and effective treatment strategies to tackle this health problem. Stroke units (SUs) appear to be the ideal setting where the management of acute stroke patients, including specific treatments as thrombolysis, may be optimized. Which model of SU gives the best results is still an unsettled issue. The more intensive and timely multidisciplinary approach to the acute phase of stroke, the management of medical complications, and the earlier and more focused rehabilitation, are likely the most qualifying aspects of our Neurovascular treatment unit.
Clinical and Experimental Hypertension, 28:377-382, 2006
Copyright © Taylor & Francis Group, LLC
ISSN: 1064-1963 print / 1525-6006 onlitie
DOI: 10.1080/10641960600549728
Which Model of Stroke Unit Is Better for Stroke
Patient Management?
SVETLANA LORENZANO, ALESSIA ANZINI, MANUELA
DE
MICHELE, ANNE FALCOU, SILVIA FAUSTI, CRISTINA
GORI, ALESSANDRA MANCINI, CRISTINA CAVALLETTI,
CARLO COLOSIMO, MARCO FIORELLI, MARIA LUISA
SACCHETTI, CORRADO ARGENTINO, AND DANILO TONI
Neurovascular Treatment Unit, Department of Neurological Sciences, University
of Rome, "La Sapienza," Rome, Itaty
The increasing prevalence of cerebrovascular diseases has made urgent the need to
develop timely and effective treatment strategies to tackle this health problem. Stroke
units (SUs) appear to be the ideal setting where the management of acute stroke
patients, including specific treatments as thrombolysis, may be
optimized.
Which
model of SU gives the best results is still an unsettled issue. The more intensive and
timely multidisciplinary approach to the acute phase of stroke, the management of
medical complications, and the earlier and more focused rehabilitation, are likely the
most qualifying aspects of our Neurovascular treatment unit.
Introduction
In the past decades the progressive ageing of world population, particularly in the industri-
alized western countries, has led to an increasing prevalence of cerebrovascutar diseases.
As one of the leading factors of mortality and the most important cause of morbidity and
long-term disability, acute stroke represents a major public health problem, imposing an
enormous social and economic burden (t,2). Therefore, the development of timely and
effective treatment strategies to tackle this crucial problem is now considered a high priority
issue.
The promising results of thrombolysis trials (3-7) have contributed to replacing the
past nihilistic attitude that considered ischemic stroke as an untreatable disease. By showing
that clinical outcome may be improved significantly by restoring adequate blood flow
within the first few hours of
stroke,
these studies boosted the concept that stroke is a medical
emergency that requires immediate hospitalization.
Address correspondence to Svctlana Lorenzano, Neurovascular Treatment Unit, Department of
Neurological Sciences, University of Rome, "La Sapienza" Viale dell'Universita 30, 00185 Rome,
Italy; E-mail: svetlana.lorenzano@uniromal.it
377
378 S. Lorenzano et al.
Stroke units (SUs) appear to be the ideal setting where this changed approach to
stroke patient care, including specific treatments as thrombolysis, may be optimized. The
first meta-analysis of all randomized controlled trials published in 1993 demonstrated the
superiority of SU care over conventional treatment of stroke patients (8). Subsequently,
these results were confirmed by the Stroke Unit Trialists' Collaboration meta-analysis
(9-11) that showed a significant reduction in morbidity and length of
stay.
Results showed
a 18% relative reduction in mortality, a 29% reduction in death or dependence, and a 25%
reduction in combined outcomes of death or need of institutional care, for patients treated
in a SU in comparison with those admitted to general medical wards. These results were
evident irrespective of sex, age, and severity of stroke. Moreover, there was an absolute
risk reduction of
3%
in all causes of mortality and in the need for nursing home care, and a
6% increase in the number of independent survivors (11).
Therefore, in terms of number of patients needed to treat (NNT) to save 1 patient
from death/dependence, SU care is as efficacious as intravenous (i.v.) thrombolysis given
within 6 hr of stroke onset (NNT 18), and it is inferior only to i.v. thombolysis administered
within 3 hr after symptom onset (NNT 8). However, while pharmacological reperfusion
may only be applied to a selected minority of acute ischemic stroke patients, SU treatment
might virtually benefit all stroke patients, and hence might have a larger impact for
stroke care in general (13, 14). In addition, it is noteworthy that some studies evaluating
the outcome of patients managed in SUs concluded that the positive effects of SU care
were still measurable up to several years following initial stroke treatment and appeared to
continue for at least 10 years (15-18, 9).
The reasons why SU care is more effective than conventional care are not definitely
clarified. Among the factors likely influencing good outcome we cite (19): well-coordinated
multidisciplinary management; stabilization of physiological parameters (20); thrombolysis
in selected patients (21); early administration of acetilsalicilic acid (22); use of anticoagulants
in patients with atrial fibrillation (13); and early mobilization (17). The evidence is so
strong that if stroke units were more widely available, stroke burden on patients and their
relatives could be highly decrease with significant social and economic implications.
However, translation of these research findings into clinical practice is very difficult without
concomitant implementation of SU care model.
Different types of SUs have been created throughout Europe (23, 24). The European
Stroke Initiative (EUSI) Recommendations for stroke management (12) define three
categories of SUs according to a more or less intensive approach:
1.
Acute SU that similarly to a coronary care unit for ischemic cardiopathy offers a more
intensive setting for acute stroke care where patients stay less than a week, with rapid
discharge to home, when it is possible, or rapid transfer to others wards.
2.
Combined acute and rehabilitation SU where the acute treatment is integrated with
rehabilitation for several weeks if necessary.
3.
Rehabilitation SU where patients are admitted for rehabilitation 1 or 2 weeks after
symptom onset, i.e., after clinical stabilization, with a length of stay of several weeks or
months if necessary.
The abovementioned meta-analysis of the Stroke Unit Trialists' Collaboration (9-11)
included mainly randomized controlled trials performed in combined acute SUs and in
rehabilitation SUs, while only
1
study was performed in an acute SU. Which model of SU
gives the best results is still an unsettled issue.
Our Neurovascular Treatment Unit (NTU) in Rome is an acute stroke unit with 6
monitored bed localized in an emergency department (ED). There are 8 neurologists
Stroke Unit Model 379
trained in stroke management and computed tomography (CT) reading on duty around
the clock offering neurological consultations to all the ED; a multidisciplinary staff
(neurosurgeons, vascular surgeons, cardiologists, anesthetists, and nutritionists) is available,
nurses and nonmedical staff are shared with the ED. Patients are continuously monitored
for electrocardiogram (ECG), heart rate, blood pressure, breathing, oxygen saturation,
body temperature, and hydroelectrolite balance. There is a rapid and preferential access to
neuroimaging diagnostic tools, Doppler ultrasonography of extra- and intracranial vessels,
echocardiography and other ED diagnostic services (radiology, nuclear medicine).
The mean length of stay is 48-72 hr, subsequently patients who cannot be discharged
home are transferred to other wards (neurological department stoke unit, neurology, vascular
surgery, neurosurgery, internal medicine).
Being localized in the ED, the NTU bas to share diagnostic resources with other
emergencies and in order to expedit early interventions for acute stroke patients diagnostic-
therapeutic pathways are defined. We differentiate emergent pathways, aimed at giving
tailored revascularization therapies, and urgent pathways aimed at defining the underlying
ethiopathogenic mechanism to assign timely the most appropriate secondary prevention
therapy.
Emergent Diagnostic-Therapeutic Pathways
On admission to the ED, a detailed neurological assessment is made by means of the
National Institute of Health Stroke Scale (NIHSS) score quantify the severity of neurological
deficit, while no differentiation of stroke subtype is attempted since this is not reliable on
simple clinical grounds (25). Whatever the degree of neurological deficit, patients
undergo CT to differentiate cerebral ischaemia from parenchymal hemorrhage, tumor, or
other focal lesions. In case of cerebral hemorrhage a neurosurgical consultation is required
and if there is not a surgical indication, the patient is admitted in the NTU. Ischemic stroke
patients with very severe deficit (stuporous or comatose) at hospital entry, after consultation
with the resuscitation
staff,
are admitted in the NTU to stabilize their conditions and
perform the examinations necessary for ethiopathogenic diagnosis and secondary prevention
(see below).
If the neurological deficit is slight to moderately severe (NIHSS score between 5 and
25),
the clinical picture is suggestive for a carotid territory stroke, the delay between onset
of symptoms and chnical observation is less than 3 hr, and the CT shows no or very limited
early signs, the patient undergoes extra- and intracranial Doppler flow study, eventually
supplemented, in case of doubts, by magnetic resonance (MR) or CT angiography. The
next step is emergent therapy that, in case of symptomatic internal carotid artery (ICA)
occlusion and patency of the ipsilateral middle cerebral artery (MCA), may be carotid
endarterectomy. Instead, in case of ICA patency or nonsignificant ICA plaques, the choice
is i.v. rt-PA irrespective of the demonstration of symptomatic MCA occlusion by (TCD),
considering the low sensitivity of TCD in detecting distal MCA branch occlusions.
However, in case of MCA patency at TCD and rapid clinical improvement, we restrain
from giving thrombolysis.
If the neurological examination suggests a diagnosis of posterior circulation stroke,
and ultrasounds, eventually completed by MR or CT angiography, detect a basilar artery
occlusion, intra-arterial tbrombolysis or, alternatively, i.v. heparin are given. When sinus
venous thrombosis is diagnosed by clinical and instrumental examinations, i.v. heparin is
given (with a target aPTT of 1.5-2 times baseline values) together with warfarin (target
INR 2 to 3). Finally, in case ultrasound examinations detect an artery dissection, confirmed
380 S. Lorenzano et al.
by MR or CT angiography, anticoagulant treatment with i.v. heparin is started followed by
oral anticoagulants.
Urgent Diagnostic-Therapeutic Pathways
These apply not only to all acute ischemic stroke patients but also to transient ischemic
attacks (TIAs), those we do not discharge immediately given the high risk of having a
stroke in the following 48 hrs (26). After entry CT, to which TIA patients also are submitted
to exclude other possible causes of a transient neurological deficit, all patients undergo
a Doppler flow study that allows us to differentiate four subgroups:
1.
Patients with definite large artery stroke, as those having a symptomatic carotid or basilar
artery severe stenosis or occlusion, whose treatment has already been discussed above.
2.
Patients with probable large artery stroke, as those with complicated (i.e., ulcerated) plaques
determining a 40% to 60% stenosis of ICA ispsilateral to the affected hemisphere.
3.
Patients with possible large artery stroke, as those with noncomplicated carotid plaques
determining a 40% to 60% stenosis.
4.
Patients without large artery stroke, as those with small nonstenosing carotid plaques or
without plaques.
In the groups 2 (after discussion with cardiologists), 3, and 4, we proceed with cardio-
logical examinations, to look for cardiac sources of emboli.
In patients with chronic atrial fibrillation (CAF), we start oral anticoagulants if there are
not contraindications. When anticoagulation may be risky, we perform transoesophageal
echocardiography (TEE) to evaluate the presence of intracardiac thrombi. Patients, with-
out CAF but with past medical history of cardiopathy and older than 45 years, undergo
first transthoracic echocardiography and, if no cardiac condition at risk of embolization is
found, they undergo TEE. TEE is the first choice examination in patients with past medical
history of cardiopathy and younger than 45 years and in all those without past medical
history of cardiopathy irrespective of age.
If a definite cardiac source of emboli is detected, oral anticoagulant therapy is started; if
no cardiac source is found, a hematological screening is performed to look for prothrombotic
states including genetic research. Moreover, surgical consultation is again required for
patients with probable large artery stroke.
Continuous Monitoring and Generai Management
During the whole stay in the NTU, patients undergo continuous monitoring of physiological
parameters (body temperature, oxygen saturation, blood pressure, and ECG) whose alter-
ations were more frequent in the acute phase of stroke and to influence the fate of the
ischemic penumbra and the clinical neurological overall clinical stabilization of the acute
stroke patients. In agreement with these observations, recent studies show that admitting
acute stroke patients to a stroke care monitoring unit rather than to a conventional stroke
unit can reduce mortality and poor outcome at 3-month follow-up (27) and that intensive
monitoring influences stroke patient outcome at discharge (19).
Early Rehabilitation
In our NTU an early rehabilitation program is instituted and tailored to the general clinical
condition of the acute stroke patient. In more severe patients, when an active training is
Stroke Unit Model 381
impossible, passive mobilization is used to prevent contractions and joint pain, deep
venous thrombosis, and pulmonary embolism and to reduce the risk of bedsores and
pneumonia that derives from immobilization. Cooperating patients actively participate
to the rehabilitation program that subsequently will be continued in a rehabilitation center
or in outpatient clinics when the patient returns at home.
Conclusion
A more intensive and timely multidisciplinary approach to the acute phase of stroke, the
management of medical complications, and an earlier and more focused rehabilitation
may be the most qualifying aspects of our NTU. We are now analyzing its efficiency in
terms of percent of patients with cerebrovascular disease entering our hospital admitted to
the NTU, and its efficacy in terms of number of dead or dependent patients in comparison
with those admitted to the NTU. The results of this analysis will be used for further
implementation of the model.
References
1.
Asplund
K,
Marke LA, Terent A, Gustafsson C, Wester P. Costs and gains
in
stroke prevention:
European perspective. Cerebrovasc Dis 1993; 3:34-42.
2.
Kaste M, Fogelholm
R,
Rissanen A. Economic burden
of
stroke
and
the evaluation
of
new thera-
pies.
Public Health 1998; 112:103-112.
3.
The
National Institute
of
Neurological Disorders Stroke rt-PA Stroke Study Group. Tissue
plasminogen activator
for
acute ischemic stroke.
N
Engl
J
Med 1995; 333:1581-1587.
4.
Hacke W, Kastc M, Fieschi C, Toni
D,
Lesaffre
E, von
Kummer R,
et
al.,
for
the ECASS Study
Group. Intravenous thrombolysis with recombinant tissue plasminogen activator
for
acute hemi-
spheric stroke,
the
European Cooperative Acute Stroke SUidy (ECASS). JAMA 1995; 274:1017-
1025.
5.
Hacke
W,
Kaste
M,
Fieschi
C, von
Kummer
R,
Davalos
A,
Meier
D, et al., for the
Second
European-Australasian Acute Stroke Study Investigators. Randomised double-blind placebo-
controlled trial
of
thrombolytic therapy with intravenous alteplase
in
acute ischaemic stroke
(ECASS II). Lancet 1998; 352:1245-1251.
6. Clark WM, Wissman
S,
Albers GW, Jhamandas JH, Madden KP, Hamilton
S.
Recombinant tis-
sue-type plasminogen activator (Alteplase)
for
ischemic stroke
3 to 5
hours after symptom
onset.
The
ATLANTIS Study:
a
randomised controlled trial. Alteplase thrombolysis
for
acute
noninterventional therapy
in
ischemic stroke. JAMA 1999; 282:2019-2026.
7.
Wardlaw J.M,
del
Zoppo
G,
Yamaguchi
T.
Thrombolysis
for
acute ischemic stroke (Cochrane
Review).
In
Cochrane Library. Oxford: Update Software, 1999;
4.
8. Langhome
P,
Williams BO, Gilchrist
W,
Howie
K. Do
stroke units save lives? Lancet
1993;
342:395-398.
9. Stroke Unit Trialists' Collaboration.
A
systematic review
of
the randomised trials
of
organised
inpatient (stroke unit) care after stroke. BrMed
J
1997; 314:1151-1159.
10.
Stroke Unit Trialists' Collaboration. Organised inpatient (stroke unit) care
for
stroke.
In
Cochrane Library. Oxford: Update Software, 2000, Issue
I.
11.
Stroke Unit Trialists' Collaboration. Organised inpatient (stroke unit) care
for
stroke.
In
Cochrane Library. Oxford: Update Software, 2002, Issue
1.
12.
The
European Stroke Initiative Executive Committee
and the
EUSI Writing Committee.
European Stroke Initiative Recommendations for Stroke Management update
2003.
Cerebrovasc
Dis
2003;
16:311-337.
13.
Hankey
GJ,
Warlow
CP.
Treatment
and
secondary prevention
of
stroke: evidence, costs,
and
effects
on
individuals and populations. Lancet 1999; 354:1457-1463.
382 S. Lorenzano et al.
14.
Hill MD. Stroke units in Canada. CMAJ 2002; 167:649-650.
15.
Strand T, Asplund K, Eriksson S, Hagg E, Lithner E, Wester P. A non-intensive stroke unit
reduces functional disability and the need for long-term hospitalization. Stroke 1985; 16:29-34.
16.
Indredavik B, Slordahl SA, Bakke F, Rokseth R, Haheim LL. Stroke unit treatment. Long-term
effects. Stroke 1997; 28:1861-1866.
17.
Indredavik B, Bakke F, Slordahl SA, Rokseth R, Haheim LL. Stroke unit treatment—10-year
follow-up. Stroke 1999; 30:1524-1527.
18.
Jorgensen HS, Kammersgaard LP, Nakayama H, Raaschou HO, Larsen K, Hubbe P, Olsen TS.
Treatment and rehabilitation on a stroke unit improves 5-year survival. A community-based
study. Stroke 1999; 30:930-933.
19.
Cavallini A, Miceli G, Marcheselli S, Quaglini S. Role of monitoring in management of acute
ischemic stroke patients. Stroke
2003;
34:2599-2603.
20.
Langhome P, Tong B, Stott DJ. Association between physiological homeostasis and early
recovery after stroke. Stroke 2000; 31:2526-2527.
21.
Wardlaw JM, del Zoppo G, Yamaguchi T. Thrombolysis for acute ischaemic stroke (Cochrane
review). In The Cochrane Library. Oxford, U.K.: Update Software,
2003,
Issue I.
22.
Gubitz G, Sandercock P, Counseil C. Antiplatelet therapy for acute ischaemic stroke (Cochrane
review). In The Cochrane Library. Oxford, U.K.: Update Software,
2003,
Issue 1.
23.
Thomassen L, Brainin M, Demarin V, Grond M, Toni D, Venables GS, for the EFNS Task
Force on Acute Neurological Stroke Care: acute stroke treatment in Europe: a questionnaire-
base survey on behalf of the EFNS task force on acute neurological stroke care. Eur J Neurol
2003;
10:199-204.
24.
Brainin M, Bornestein N, Boysen G, Demarin V, for the EFNS Task Force on Acute Neurolog-
ical Stroke Care: acute neurological stroke care in Europe: results of the European stroke care
inventory. Eur J Neurol 2000; 7:5-10.
25.
Toni D. Hyperacute diagnosis of subcortical infarction. In Lacunar and Other Subcortical
Infarctions. Oxford: Oxford University Press, 2002; 184-94.
26.
Johnston SC, Gress DR, Browner WS, Sidney S. Short-term prognosis after emergency depart-
ment diagnosis of
TIA.
JAMA 2000; 284:2901-2906.
27.
Suiter G, Willen E, Langedijk M, Maurits N, de Keyser J. Admitting acute ischemic stroke
patients to a stroke care monitoring unit versus a conventional stroke unit. A randomized pilot
study. Stroke
2003;
34:101-104.
... Es probable que la presencia de un equipo multidisciplinario dedicado exclusivamente a la atención de enfermos con stroke agudo explique la menor estancia en la US. La formación de un equipo multidisplinario para el tratamiento del stroke ha mejorado los resultados, como mencionan varios trabajos 3,8,9 . El equipo médico estipuló un plan de estudios neurológicos y vasculares velozmente. ...
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Thrombolytic therapy for acute ischemic stroke has been approached cautiously because there were high rates of intracerebral hemorrhage in early clinical trials. We performed a randomized, double-blind trial of intravenous recombinant tissue plasminogen activator (t-PA) for ischemic stroke after recent pilot studies suggested that t-PA was beneficial when treatment was begun within three hours of the onset of stroke. METHODS: The trial had two parts. Part 1 (in which 291 patients were enrolled) tested whether t-PA had clinical activity, as indicated by an improvement of 4 points over base-line values in the score of the National Institutes of Health stroke scale (NIHSS) or the resolution of the neurologic deficit within 24 hours of the onset of stroke. Part 2 (in which 333 patients were enrolled) used a global test statistic to assess clinical outcome at three months, according to scores on the Barthel index, modified Rankin scale, Glasgow outcome scale, and NIHSS: RESULTS: In part 1, there was no significant difference between the group given t-PA and that given placebo in the percentages of patients with neurologic improvement at 24 hours, although a benefit was observed for the t-PA group at three months for all four outcome measures. In part 2, the long-term clinical benefit of t-PA predicted by the results of part 1 was confirmed (global odds ratio for a favorable outcome, 1.7; 95 percent confidence interval, 1.2 to 2.6). As compared with patients given placebo, patients treated with t-PA were at least 30 percent more likely to have minimal or no disability at three months on the assessment scales. Symptomatic intracerebral hemorrhage within 36 hours after the onset of stroke occurred in 6.4 percent of patients given t-PA but only 0.6 percent of patients given placebo (P < 0.001). Mortality at three months was 17 percent in the t-PA group and 21 percent in the placebo group (P = 0.30). CONCLUSIONS: Despite an increased incidence of symptomatic intracerebral hemorrhage, treatment with intravenous t-PA within three hours of the onset of ischemic stroke improved clinical outcome at three months.
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Objective. —To evaluate the efficacy and safety of intravenous thrombolysis using recombinant tissue plasminogen activator (rt-PA) in patients with acute ischemic stroke.Design. —Randomized, prospective, multicenter, double-blind, placebo-controlled clinical trial.Setting. —A total of 75 hospitals in 14 European countries.Patients. —A total of 620 patients with acute ischemic hemispheric stroke and moderate to severe neurologic deficit and without major early infarct signs on initial computed tomography (CT).Intervention. —Patients were randomized to treatment with 1.1 mg per kilogram of body weight of rt-PA (alteplase) or placebo within 6 hours from the onset of symptoms.Outcome Measures. —Primary end points included Barthel Index (BI) and modified Rankin Scale (RS) at 90 days. Secondary end points included combined BI and RS, Scandinavian Stroke Scale (SSS) at 90 days, and 30-day mortality. Tertiary end points included early neurologic recovery (SSS) and duration of in-hospital stay. Safety parameters included mortality and incidence of intracranial or extracranial hemorrhage.Results. —The distribution of demographic variables was similar among patients in the rt-PA and placebo treatment arms in both the intention-to-treat (ITT) analysis and the explanatory analysis for the target population (TP). A total of 109 patients (17.4%) were included in the trial despite major protocol violations but excluded from the TP. There was no difference in the primary end points in the ITT analysis, while the TP analysis revealed a significant difference in the RS in favor of rt-PA—treated patients (P<.035). Of the secondary end points, the combined BI and RS showed a difference in favor of rt-PA—treated patients in both analyses (P<.001). Neurologic recovery at 90 days was significantly better for rt-PA—treated patients in the TP (P=.03). The speed of neurologic recovery assessed by the SSS was significantly better up to 7 days in the ITT analysis and up to 30 days for the TP in the rt-PA treatment arm. In-hospital stay was significantly shorter in the rt-PA treatment arm in both analyses. There were no statistically significant differences in the mortality rate at 30 days or in the overall incidence of intracerebral hemorrhages among the rt-PA and placebo treatment arms in either analysis. However, the occurrence of large parenchymal hemorrhages was significantly more frequent in the rt-PA—treated patients.Conclusions. —Intravenous thrombolysis in acute ischemic stroke is effective in improving some functional measures and neurologic outcome in a defined subgroup of stroke patients with moderate to severe neurologic deficit and without extended infarct signs on the initial CT scan. However, the identification of this subgroup is difficult and depends on recognition of early major CT signs of early infarction. Therefore, since treating ineligible patients is associated with an unacceptable increase of hemorrhagic complications and death, intravenous thrombolysis cannot currently be recommended for use in an unselected population of acute ischemic stroke patients.(JAMA. 1995;274:1017-1025)
Article
Stroke is a major health problem in all industrialised countries and evidence is mounting that this problem also affects the developing countries. In the industrialised countries, it is the third largest killer and, of the survivors, about one-half are left with a permanent handicap. Despite the huge burden of stroke on healthcare and social services (several USA studies estimate the annual cost of stroke to be between US $6.5 and 11.2 billion) the cost of strokes has aroused little attention. An absence of effective therapies may be one of the reasons for this lack of interest; the costs have been taken as inevitable. With the advent of new therapies for acute ischaemic stroke (thrombolytics and neuroprotectants) there is renewed interest in improving both the management and outcome for patients. Key to the evaluation (both clinical and economic) of new stroke therapies is the choice of evaluation scales/instruments. Increasingly, stroke investigators are using measures of functional outcome (for example the Barthel index) as a primary endpoint in stroke trials. This is pertinent, as functional outcome has been found to reflect reasonably well the degree to which a patient needs support after stroke, irrespective of whether this is provided by the family or society.
Article
Patients who receive organised stroke unit care are more likely to survive their stroke, return home and make a good recovery. Organised stroke unit care is a form of care provided in hospital by nurses, doctors and therapists who specialise in looking after stroke patients and work as a coordinated team. Patients who receive this care are more likely to survive their stroke, return home and become independent in looking after themselves. A variety of different types of stroke unit has been developed. The best results seem to come from those which are based in a dedicated ward.
Article
Context Recombinant tissue-type plasminogen activator (rt-PA) improves outcomes for patients with acute ischemic stroke, but current approved use is limited to within 3 hours of symptom onset. This restricts the number of patients who can be treated, since most stroke patients present more than 3 hours after symptom onset.Objective To test the efficacy and safety of rt-PA in patients with acute ischemic stroke when administered between 3 and 5 hours after symptom onset.Design The Alteplase ThromboLysis for Acute Noninterventional Therapy in Ischemic Stroke (ATLANTIS) study is a phase 3, placebo-controlled, double-blind randomized study conducted between December 1993 and July 1998, with up to 90 days of follow-up.Setting One hundred forty university and community hospitals in North America.Patients An intent-to-treat population of 613 acute ischemic stroke patients was enrolled, with 547 of these treated as assigned within 3 to 5 hours of symptom onset. A total of 39 others were treated within 3 hours of symptom onset, 24 were treated more than 5 hours after symptom onset, and 3 never received any study drug.Intervention Administration of 0.9 mg/kg of rt-PA (n = 272) or placebo (n = 275) intravenously over 1 hour.Main Outcome Measures Primary efficacy was an excellent neurologic recovery at day 90 (National Institutes of Health Stroke Scale [NIHSS] score of ≤1); secondary end points included excellent recovery on functional outcome measures (Barthel index, modified Rankin scale, and Glasgow Outcome Scale) at days 30 and 90. Serious adverse events were also assessed.Results In the target population, 32% of the placebo and 34% of rt-PA patients had an excellent recovery at 90 days (P = .65). There were no differences on any of the secondary functional outcome measures. In the first 10 days treatment with rt-PA significantly increased the rate of symptomatic intracerebral hemorrhage (ICH) (1.1% vs 7.0% [P<.001]), a symptomatic ICH (4.7% vs 11.4% [P = .004]), and fatal ICH (0.3% vs 3.0% [P<.001]). Mortality at 90 days was 6.9% with placebo and 11.0% with rt-PA (P = .09). Results in the intent-to-treat population were similar.Conclusions This study found no significant rt-PA benefit on the 90-day efficacy end points in patients treated between 3 and 5 hours. The risk of symptomatic ICH increased with rt-PA treatment. These results do not support the use of intravenous rt-PA for stroke treatment beyond 3 hours. Figures in this Article The Food and Drug Administration (FDA) approval in June 1996 of intravenous recombinant tissue-type plasminogen activator (rt-PA) for patients with acute ischemic stroke treated within 3 hours of symptom onset marked a historic first step in treating this devastating disease. This approval was primarily based on the results of the National Institute of Neurologic Disorders (NINDS) trials (1 and 2).1 In the NINDS trials, patients with ischemic stroke were treated within 3 hours of symptom onset with either 0.9 mg/kg of rt-PA (alteplase) (maximum dose <90 mg) or placebo. A significant 11% to 15% absolute benefit was found favoring rt-PA despite a significant increase in the symptomatic intracerebral hemorrhage (ICH) rate (6.4% vs 0.6%; P<.001) at 36 hours. The current approved use of rt-PA is limited to otherwise eligible patients in whom treatment can be initiated within 3 hours after the onset of stroke symptoms. This greatly restricts the number of patients who could potentially be treated, because most stroke patients present more than 3 hours after symptom onset.2 This time limitation is reflected in the finding that, since approval, less than 5% of all stroke patients are receiving rt-PA.3- 5 This raises the question of whether intravenous rt-PA is still relatively safe and effective if given beyond 3 hours after stroke. This question is particularly important in light of a recent phase 4 trial in North America finding that more than 15% of patients receiving rt-PA are actually being treated after 3 hours from symptom onset even at experienced stroke centers.6 The objective of this phase 3 study, Alteplase ThromboLysis for Acute Noninterventional Therapy in Ischemic Stroke (ATLANTIS), was to assess the efficacy, as measured by improved clinical outcome, and relative safety of 0.9 mg/kg of rt-PA vs placebo in acute ischemic stroke patients treated between 3 and 5 hours of stroke onset.