From the Departments of Neuroradiology (F.G., L.R., C.O., K.-O.L., G.S.)
and Neurology (F.G., H.M., M.S., R.B., C.B.), Inselspital, University of
Berne, Berne, Switzerland.
Correspondence to Gerhard Schroth, MD, Head of Neuroradiology, Inselspital, 3010 Bern, Switzerland. E-mail gerhard.schroth{at}insel.ch
Methods—Forty-three patients were treated with LIT using
urokinase (median dose, 0.75x106 IU). The median National
Institutes of Health Stroke Scale (NIHSS) score at hospital admission
was 18 (range, 9 to 36). Nine patients had occlusions of the internal
carotid artery (ICA), 23 of the middle cerebral artery (MCA), 1 of the
anterior cerebral artery, and 10 of the basilar artery (BA). Outcome
was assessed after 3 months and classified as good for Rankin Scale
(RS) scores of 0 to 3 and poor for RS scores of 4 or 5 and death.
Results—Nine patients (21%) recovered to RS scores 0 or 1, 17
(40%) to scores of 2 or 3, and 7 (16%) to scores of 4 or 5. Ten
patients (23%) died. Outcome was good in 17 patients (80%) with MCA
occlusions, in 3 patients (33%) with ICA, and in 5 patients (50%)
with BA occlusions. Good outcome was associated with an initial NIHSS
score of <20 (P<0.001), improvement by 4 or more
points on NIHSS score within 24 hours (P=0.001), and
vessel recanalization (P=0.02).
Recanalization was more likely if LIT was started
within 4 hours (P=0.01). Symptomatic
cerebral hemorrhage occurred in 2 patients (4.7%).
Conclusions—LIT was most efficacious in patients with MCA and BA
occlusions when the initial NIHSS score was less than 20 and when
treated within 4 hours. It is of limited value in patients with distal
ICA occlusions.
The purpose of this study was to evaluate the safety and efficacy of
LIT using urokinase in patients with acute ischemic stroke of
the anterior or posterior circulation and to determine the influence of
clinical and radiological parameters on outcome.
Clinical assessment was performed at admission, 24 hours after LIT, and
before discharge using the National Institutes of Health Stroke Scale
(NIHSS).7
Primary neuroradiological assessment was performed with CT in 42
patients and with MRI in 1. Selective intra-arterial
digital subtraction angiography was performed on a biplane,
high-resolution angiography system (Toshiba CAS 500, Tokyo, Japan) with
a matrix of 1024x1024 pixels. A 5.5 F-JB2 (Valavanis, Cook, Denmark)
catheter was used via the femoral approach for diagnostic
cerebral panangiography in each patient to visualize the collateral
flow and the occluded vessel.
LIT was performed according to clinical, CT, and angiographic findings
and after information and consent of the patient and his/her family. At
least 2 members of the stroke team, a neurologist and neuroradiologist,
decided on its indication in the angiography suite. Using a
microcatheter, mostly a Fast Tracker (Target Therapeutics) through the
5.5 F-JB2 catheter, which was navigated into the occluded vessel using
biplane road map technique, a median dose of 750 000 IU urokinase
(Urokinase HS Medac) (range, 20 000 to 1 250 000 IU) was infused
either directly into or near the proximal end of the thrombus over 60
minutes. In 7 patients with atherosclerotic stenoses at the
intracranial occlusion site and 1 patient with a stenosis at
the internal carotid artery (ICA) origin, the stenoses were
additionally dilated by percutaneous transluminal
angioplasty (PTA), using a stealth PTA balloon catheter (Target
Therapeutics). Treatment effect after thrombolysis was documented by a
nonselective control arteriogram (see Tables 3
Occlusions were categorized as seen on angiograms before LIT.
Collaterals were classified in 2 groups: none/minimal, if none or
minimal intracranial or leptomeningeal anastomoses were present and
therefore no sufficient filling of the territory distal to the
occlusion was visible; and moderate/maximal, if moderate or maximal
filling of extracranial, intracranial (circle of Willis), or
leptomeningeal anastomoses with sufficient filling of the postocclusion
vascular territory was seen.
The achieved vessel recanalization was classified
as described by Mori and coworkers9 : grade 0,
unchanged; grade 1, movement of thrombus not associated with any
improvement in perfusion; grade 2, partial
recanalization with perfusion in less than 50% of
the ischemic area; grade 3, partial
recanalization with reperfusion in more than 50%
of the ischemic area; or grade 4, complete or nearly complete
recanalization with full return of perfusion. The
threshold of 50% was taken in the later analysis of low
(<50%) and high (>50%) grades of
recanalization.9
Neurological improvement (NI) at 24 hours was defined as improvement of
4 or more points on the NIHSS. Either CT or high-field MRI were
repeated within 3 days after LIT.
The etiology of stroke was determined after the acute phase with the
help of additional investigations as deemed necessary in each patient.
It was classified according to the Trial of Org 10172 in Acute Stroke
Treatment criteria.10
Outcome assessment was carried out by a clinical examination 3 months
after LIT using the modified Rankin scale (RS), which is known to have
a high interobserver agreement11 : RS scores of 0
to 3 were defined as "good" and scores of 4 or 5 and death (RS 6)
as "poor" outcomes. Also, to compare our results with those from
the NINDS study, the outcomes were grouped into 4 categories: RS scores
of 0 to 1, 2 to 3, 4 to 5, and death.
Statistical analysis was performed using the
Etiology
Outcome
National Institute of Health Stroke Scale Score at Admission
and Outcome
Delay to Treatment and Outcome
Vessel Recanalization and Outcome
Delay to Treatment and Vessel Recanalization
Neurological Improvement Within 24 Hours and Outcome
Collaterals, Recanalization, and
Outcome
Hemorrhage
Deaths
Occlusions in the Anterior Circulation
Twenty-three patients suffered occlusions of the MCA. Seventeen
patients (74%) had a good outcome. Patients with MCA occlusions had
better outcomes than those with ICA occlusions
(
The NIHSS score was less than 20 in 18 patients and associated with a
good outcome in 16 patients (89%). As in distal ICA occlusions, 4 of 5
patients with severe MCA strokes with an NIHSS score of
The presence of the hyperdense MCA sign (HMCAS) was analyzed
for the 32 patients with ICA or MCA occlusion. Twenty-six patients had
angiographically proven occlusions of the M1 segment. Twenty-three of
them (88%) showed a HMCAS. No patient with a patent M1 segment showed
a positive HMCAS. Accordingly, in the 6 patients with occlusions of the
M2–M4 segments, the HMCAS was absent. The 23 patients with HMCAS had a
median NIHSS score of 19 (range, 11 to 24) on admission. This value was
not different from the median NIHSS score of 17 (range, 9 to 21) of the
9 patients without HMCAS. Ten of 12 patients (83%) with a poor (83%)
and 13 of 20 (65%) with a good outcome had a positive HMCAS
(
A 70-year-old man suffered an anterior cerebral artery occlusion.
His initial NIHSS score was 10 at admission.
Recanalization was achieved within 3 hours. He
recovered to RS 3.
Occlusions of the BA
Four patients (40%) died due to strokes in the BA territory. Two of
them were comatose at admission. Three of them had an atherosclerotic
etiology of the occlusion and died despite the fact that
recanalization was achieved.
The NIHSS score is a measure of the severity of stroke. Our patients
with an NIHSS score of
Patients whose occluded vessels recanalized had a better prognosis than
patients whose vessels did not. This corroborates findings of other
studies in which intra-arterial or intravenous
thrombolysis was used, where
recanalization was also associated with a better
prognosis.14 15 16 The
recanalization rate for all of our patients was
63%, for patients with distal ICA occlusions 33%, and for those with
MCA occlusions 56%. These figures are similar to other
intra-arterial thrombolysis studies (64%,
range 40% to 100%, in a
meta-analysis).17 In acute MCA strokes
Bollaert and coworkers18 achieved 58%
recanalizations using intraarterial
urokinase and Zeumer and coworkers19 49% using
intra-arterial rtPA. PROACT, the only randomized trial on
intra-arterial thrombolysis, obtained 58%
MCA recanalizations with recombinant pro-urokinase
and proved its superiority to placebo.2
Delay to treatment has been identified as an additional factor for
success of intravenous
thrombolysis.13 20 In our
patients, delay to treatment did not have a directly measurable effect
on outcome. This may be because of our small sample. However, the
earlier treatment was begun, the more likely the occluded vessel was to
recanalize; because recanalization was associated
with a better prognosis, earlier treatment may have favored a good
outcome indirectly.
NI within 24 hours has been shown to be an additional criterion
associated with a favorable outcome.21 22 It
occurred in 26% of our patients and was significantly related to a
good outcome. It possibly reflects the effect of
recanalization restoring neuronal function in the
penumbra.
HMCAS on initial CT had no prognostic value in our patients. This is in
line with other stroke trials that showed no correlation or only a poor
correlation between HMCAS and outcome, whether patients were treated or
not.23 24 25 26 Conversely, Tomsick and
coworkers27 observed mostly poor clinical
outcomes in a series of patients treated within 90 minutes with
intravenous rtPA when HMCAS was present. However, in
their study, the median baseline NIHSS score of HMCAS-positive patients
was 19.5 compared with 10 with HMCAS-negative patients, and this may
have accounted for the different clinical outcome in their patients. In
our series, HMCAS-positive and -negative patients had an NIHSS score in
the same order. Von Kummer et al24 found that the
HMCAS per se was of low prognostic value. However, it predicted a fatal
outcome if extended hypodensity or brain swelling was seen in addition
to the HMCAS on CT, ie, when extensive brain damage had already
occurred. There was no correlation between HMCAS and
recanalization in our patients or in another
series,25 which further underscores the low
prognostic value of HMCAS.
The site of occlusion plays a key role in the outcome of stroke. In the
anterior circulation, patients with carotid occlusions were
characterized by severe neurological deficits, poor
recanalization rates, and worse outcomes than those
with MCA occlusions. However, our patients with carotid
occlusions did not fare as badly as the patients studied by Zeumer et
al.19 Zeumer and
coworkers19 reported a fatal outcome in 59% and
persistent severe neurological deficits in 38% of patients with
carotid T occlusions. The recanalization of 17%
was low. In comparison, 3 of our 9 carotid occlusion patients' vessels
recanalized and they had a good outcome. Therefore, we still think that
LIT in carotid occlusions is worth attempting and that it has the
potential to spare some patients a large stroke.
Patients with BA thrombosis have a poor prognosis when
recanalization does not occur. In large series,
mortality was 86% to 92%.28 29 LIT enhances the
recanalization rate, gives the patient with
recanalization a fair chance of favorable outcome,
and reduces mortality significantly. Five of our 8 patients (63%) who
recanalized had a good and 2 who did not had a poor outcome. However, 2
who were comatose at admission died despite successful
recanalization. Our data on BA occlusions are in
line with larger series and support the opinion that LIT should be
attempted in noncomatose patients with BA
occlusion.19 28 29
Symptomatic hemorrhages occurred in 4.7% of our
patients. One of them (2.3%) bled 3 days after LIT while under
heparin, which may have caused the
hemorrhage.18 The spontaneous bleeding
rates were 1.2% in NINDS and 6.5% in European Cooperative Acute
Stroke Study (ECASS) control groups.1 20 30 A
meta-analysis showed spontaneous rates of 2.6% and 9.6% with
intravenous thrombolysis. Our 4.7% are in
the same range or only slightly elevated compared with the spontaneous
course, but higher than the 0.7% reported by Théron and
coworkers5 in 142 patients.
It seems that intra-arterial thrombolysis
carries a smaller risk of bleeding than intravenous
thrombolysis, but to date direct comparisons of
intra-arterial and intravenous
thrombolysis have not been done.
Recanalization rates, which relate to outcome, were
higher after intra-arterial application of the
fibrinolytics than in a study with intravenous
administration of rtPA (63% versus 29%).25
In the placebo-controlled NINDS study, 157 patients were treated within
90 minutes and 155 within 180 minutes.1 In our
study the median delay to treatment was 285 minutes. The median NIHSS
score at admission in NINDS was 14 (range, 1 to 36) and in the
present series 18 (range, 9 to 36). Mean age in NINDS was 69±12
years, 16 years greater than in the present series. "Small vessel
occlusive" strokes were included in NINDS, in the present series
they were not. In summary, compared with NINDS, patients in this series
suffered more severe strokes, treatment was started later, and only
patients with angiographically confirmed vessel occlusions were
treated. Only the younger age favored our patients. All these
differences limit a comparison. If, nonetheless, outcomes are compared,
our LIT patients had the same ratio of good versus poor outcomes as in
NINDS part 2 subset (LIT, 1.53 to 1; NINDS, 1.5 to 1).
According to indirect comparisons of intravenous and
intra-arterial thrombolysis, a cautious
statement would be that LIT is at least as effective and safe as
intravenous thrombolysis with rtPA and it
can be applied with a longer time window. In addition, LIT has several
advantages. Angiography performed before LIT visualizes the individual
vascular pathology; it gives information on collateral flow; the
thrombolytic agent can be applied into the thrombus
under visual control; the fibrinolytic dose needed for vessel
recanalization is smaller than in systemic
thrombolysis; sometimes the thrombus can be fragmented
and dislodged mechanically; and PTA can be performed through the same
guiding catheter.5 31 32 33 34 35 The risk of
symptomatic intracranial hemorrhage does not seem
to increase or at least not as much as in systemic
thrombolysis.
Limitations of LIT are that it can be delivered only at large
institutions with an interventional neuroradiological service. Some
angiograms will be performed in vain, eg, when spontaneous
recanalization takes place before angiography, when
stroke is due to microangiopathy, or when an ICA occlusion prevents LIT
of an occluded MCA.
It is our impression that patients with occlusions of large cerebral
arteries such as the ICA, MCA main stem, or the BA gain most from LIT,
whereas patients with branch occlusions are served as well with
intravenous treatment. However, to corroborate such a
statement a direct comparison of intra-arterial and
intravenous thrombolysis would be
necessary.
In conclusion, the present study indicates that LIT with urokinase
in acute ischemic stroke is a safe treatment and that it
achieves a high recanalization rate correlating
with a good outcome, especially within the first 4 hours. It is less
efficacious in comatose patients with BA occlusions and in patients
with carotid T occlusions. An NIHSS score of
Received April 7, 1998;
revision received May 28, 1998;
accepted May 28, 1998.
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© 1998 American Heart Association, Inc.
Original Contributions
Local Intra-Arterial Thrombolysis in Acute Ischemic Stroke
Abstract
Top
Abstract
Introduction
Subjects and Methods
Results
Discussion
References
Background and Purpose—We performed
a retrospective analysis of the prognostic factors in patients
treated with local intra-arterial
thrombolysis (LIT). The purpose of this study was to
evaluate the safety and efficacy of LIT using urokinase in patients
with acute ischemic stroke of the anterior or posterior
circulation and to determine the influence of clinical and radiological
parameters on outcome.
Key Words: angiography, digital subtraction • fibrinolysis • stroke, acute • thrombolysis • urokinase
Introduction
Top
Abstract
Introduction
Subjects and Methods
Results
Discussion
References
Thrombolysis using
intravenous recombinant tissue plasminogen
activator (rtPA) for acute ischemic stroke is
encouraging since it increased the number of patients with good
functional outcome in the National Institute of Neurological Disorders
and Stroke (NINDS) trial, and the recently published PROACT trial may
renew the interest in local intra-arterial
thrombolysis (LIT) because it enhances the
arterial recanalization
rate.1 2 Intravenous
thrombolysis has been criticized as being a "shotgun
approach" because it ignores specificity.3
However, there are no randomized trials comparing
intravenous thrombolysis with LIT. Only a
few reports from uncontrolled trials have suggested that LIT may be
more efficacious than intravenous
thrombolysis.4 5 6
Subjects and Methods
Top
Abstract
Introduction
Subjects and Methods
Results
Discussion
References
From December 1992 to July 1, 1997, 43 patients (19
women, 24 men; mean±SD age, 52.9±14.5 years; range, 12.7 to 74.6
years) with acute ischemic stroke were treated with LIT in our
hospital. Patients were treated if (1) clinical diagnosis was
established by a staff neurologist; (2) CT excluded intracranial
hemorrhage or other nonvascular anomaly; (3) digital
subtraction angiography demonstrated a vascular pathology explaining
the neurological deficit; (4) the delay from symptom onset to LIT
therapy was less than 6 hours or substantial worsening of stroke signs
had occurred within the last 4 hours; (5) their age was less than 75
years; and (6) there were no individual contraindications or laboratory
anomalies advising against the use of
thrombolytics. 
and 4), performed in
identical biplane projections as the initial diagnostic angiogram
before thrombolysis. Immediately after LIT, 27 patients received
heparin in a dose doubling the activated thromboplastin time.
After publication of the International Stroke Trial results, heparin
was replaced by aspirin.8 Aspirin was given to 16
patients.
View this table:
[in a new window]
Table 3. Vessel Recanalization After LIT as Seen on the
Control Arteriogram and Outcome as Assessed After 3
Months
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[in a new window]
Table 4. Vessel Recanalization After LIT as Seen on the
Control Arteriogram and Delay From Symptom Onset to
LIT 
2 test for cross-tabulation with 1 or 2
degrees of freedom (df). For analysis of
correlation, we calculated the nonparametric Spearman
correlation coefficient rs and the
corresponding 2-tailed significance. P
0.05 was considered
significant.
Results
Top
Abstract
Introduction
Subjects and Methods
Results
Discussion
References
The clinical and neuroradiological baseline characteristics and
outcome categories are shown in Table 1 for each type of occlusion. The
occlusion sites were as follows: ICA in 9 patients (21%; 6 of them
with carotid "T" occlusions), middle cerebral artery (MCA) in 23
patients (53%; M1 segment in 17 [40%]; M2-4 segments in 6
[13%]), anterior cerebral artery in 1 patient (2.3%), and basilar
artery (BA) in 10 patients (23%).
View this table:
[in a new window]
Table 1. Clinical and Neuroradiological Baseline
Characteristics, Type of Occlusion, and Outcome of 43 Patients Treated
With LIT
Large-artery atherosclerosis was present in 10
patients (23%), cardioembolism in 19 (44%), stroke of
other determined etiology in 4 (9%), and stroke of undetermined
etiology in 10 (23%). There was no lacunar infarction due to
small-vessel occlusion. Twelve patients (28%) had had previous
cerebrovascular events and 39 (91%) had vascular risk factors.
Twenty-six patients (60%) had a good and 17 (40%) a poor
outcome. In detail, 9 patients (21%) recovered to RS score of 0 or 1,
17 (40%) retained a mild disability (RS 2 or 3), 7 (16%) remained
severely disabled (RS 4 or 5), and 10 (23%) died.
The median stroke severity measured at admission was 18 (range, 9
to 36). Twenty-three of 27 patients (85%) with NIHSS score of <20 at
admission experienced a good outcome. In contrast, only 3 of 16
patients (19%) with a score of 
20 had a good outcome. Eight of the
10 deaths occurred in this subset. The severity of stroke measured as
NIHSS score at admission had a statistically significant influence on
the outcome (2=20.0, df=2,
P<0.001; Table 2).
View this table:
[in a new window]
Table 2. Stroke Severity (NIHSSS) at Admission and Outcome
as Assessed 3 Months After
LIT
The median delay from symptom onset to LIT was 285 minutes (range,
130 to 840 minutes). Sixteen patients (35%) were treated within 4
hours and 36 patients (84%) within 6 hours. Twelve of the 16 patients
(75%) treated within 4 hours had a good outcome. Twenty-seven patients
(65%) were treated after 4 hours, 14 (52%) had a good outcome and 13
(48%) a poor outcome. The data show a trend toward a more favorable
outcome in patients treated within 4 hours, but this trend was not
significant (2=1.8, df=1,
P=0.17).
The occluded vessel was recanalized successfully in 27 patients.
This corresponds to a recanalization rate of 63%.
Twenty of these 27 patients (74%) had a good outcome. In contrast,
only 6 of 16 patients (38%), in whom
recanalization was not achieved, did well.
Successful recanalization was significantly
associated with a good outcome (2=5.62,
df=1, P=0.018; Table 3
).
Fourteen of 15 patients (93%) treated within 4 hours had
recanalizations >50%. Patients treated after 4
hours showed a slight preponderance of poor
recanalization <50% (15 versus 13 patients). The
delay to LIT had a significant effect on the
recanalization rate
(2=9.2, df=2, P=0.01; Table 4).
Eleven patients had an NI. All improved to a good outcome. The NI
was strongly associated with a good outcome
(2=9.7, df=1, P=0.002;
Table 5).
View this table:
[in a new window]
Table 5. Neurological Improvement of 4 or More Points on
NIHSS 24 Hours After LIT and Outcome 3 Months
Later
Collaterals were moderate or maximal in 21 patients. In 16 (76%)
recanalization was achieved. Twenty-two patients
had minimal or no collaterals. Recanalization was
successful in only 11 patients (50%). There was no association between
collaterals and recanalization or between
collaterals and outcome.
Asymptomatic hemorrhage was detected in 6
patients (14%) examined with MRI. All hemorrhages, mostly
cortical, were in the ischemic brain parenchyma.
Symptomatic intraparenchymal hemorrhage occurred
in 2 patients (4.7%) with MCA M1 occlusions, a 61-year-old man and a
68-year-old woman. The man had a NIHSS score of 12 and recovered to a
slight disability (RS score of 2). The woman had a NIHSS score of 21
and died due to transtentorial herniation 4 days after LIT.
Ten patients died (23%), 6 due to progressing edema and
transtentorial herniation and 4 due to a brain stem stroke. Eight had
an NIHSS score of 20 at admission. Collaterals were minimal or absent
in 8 and recanalization was <50% in 6
patients.
Nine patients had occlusions of the ICA, 6 of them carotid T
occlusions. Outcome was good in 3 (33%; all T occlusions) and poor in
6 (67%). Two patients died. Five patients (56%) had severe
neurological deficits of NIHSS score 20 at admission. Four of them
had a poor outcome. The recanalization rate (33%)
was lower than in the other patients. 2=4.5, df=1, P=0.03;
Table 6).
Recanalization was achieved in 13 of 17 patients
(76%) with good outcomes and in 2 of 6 (30%) with poor outcomes
(2=3.63, df=1, P=0.056).
Collaterals were not different in the 2 outcome groups. The MCA main
stem (M1 segment) was occluded with lenticulostriate arteries in 14
patients (61%). Eight of them (57%) had a good outcome, 3 a poor
outcome, and 3 died. In 3 patients the occlusion of M1 was distal to
the lenticulostriate arteries, and in 6 only MCA branches were occluded
(Table 7). They all had a good outcome.
There was a nonsignificant trend toward better outcomes with more
distal MCA occlusions (2=5.2, df=2,
P=0.074).
View this table:
[in a new window]
Table 6. Comparison of ICA and MCA Occlusions and Outcome
After 3 Months
View this table:
[in a new window]
Table 7. Occlusion Site in the MCA and Outcome After 3
Months 20 on
admission had a poor outcome. However, the relative number of patients
with such severe strokes (5/23, 22%) was lower than in the group with
ICA occlusions (5/9, 56%). 2=1.24, df=1, P=0.26).
Furthermore, there was no significant correlation between HMCAS and
recanalization.
Ten patients suffered from BA occlusion. Five had a good outcome.
Four patients with NIHSS score <20 on admission had a good outcome,
whereas 5 of 6 patients with severe strokes (NIHSS 20) had a poor
outcome. There was no association of good outcome to early treatment
within 4 hours from symptom onset. Three patients were treated after 6
hours. Two of them had a poor outcome. Collaterals did not affect the
outcome. Recanalization >50% was achieved in 8
patients (80%), 5 of them (62.5%) had a good outcome.
Asymptomatic hemorrhage occurred in 1 patient.
Discussion
Top
Abstract
Introduction
Subjects and Methods
Results
Discussion
References
In this series of 43 stroke patients treated with LIT, 60% had a
good and 40% a poor outcome. Outcome was significantly related to
severity of stroke measured as NIHSS score at admission, vessel
recanalization, NI within 24 hours, and location of
vessel occlusion in the anterior circulation. Delay to treatment had an
indirect effect on outcome, but collaterals as seen on angiograms,
HMCAS, and etiology of stroke did not influence it. 20 at admission had a worse prognosis than
patients with a score of <20. A correlation between severity of stroke
and outcome has been observed in other stroke trials as
well.1 12 13 A large infarct is associated with a
high NIHSS score and has a worse prognosis than a small stroke with a
low NIHSS score. In the NINDS trial, lacunar strokes had the best
prognosis.1 20 is an
unfavorable sign as well.
Acknowledgments
We thank Pietro Ballinari, PhD, for statistical advice.
References
Top
Abstract
Introduction
Subjects and Methods
Results
Discussion
References
1.
The National Institute of Neurological Disorders,
and Stroke rt-PA Stroke Study Group to tissue plasminogen
activator for acute ischemic stroke. N
Engl J Med. 1995;333:1581–1587.
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