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ORIGINAL ARTICLE

Outcome of acute ischaemic stroke patients after

intravenous alteplase in Hospital Universiti Sains Malaysia

Kuan Yew Wong, MBBS1,2, Kamarul Aryffin Baharuddin, MMed1,5, Mohamad Masykurin Mafauzy, MMed1,5,
Sanihah Abdul Halim, MD, MMed3,5, Yong Chuan Chee, MBBS, MRCP3,5, Nur Asma Sapiai, MMed4,5, Mohd Shafie
Abdullah, MMed4,5

1
Department of Emergency Medicine, School of Medical Sciences, Universiti Sains Malaysia, Kubang Kerian, Kelantan, Malaysia,
2
Hospital Tanah Merah, Tanah Merah, Kelantan, Malaysia, 3Department of Internal Medicine (Neurology), School of Medical
Sciences, Universiti Sains Malaysia, Kubang Kerian, Kelantan, Malaysia, 4Department of Radiology, School of Medical Sciences,
Universiti Sains Malaysia, Kubang Kerian, Kelantan, Malaysia, 5Hospital Universiti Sains Malaysia, Jalan Raja Perempuan
Zainab 2, Kubang Kerian, Kelantan, Malaysia

ABSTRACT
Introduction: Intravenous (IV) thrombolysis with
life years.2 It is estimated that 14 million people worldwide

recombinant tissue plasminogen activator (rt-PA) is effective

will suffer their first stroke and 80 million live with the

in treating acute ischaemic stroke. Our primary objective is

burden of stroke. Stroke also accounts for 116 million years of

to assess the outcome of these acute ischaemic stroke (AIS)

healthy life lost to the disease.1 This equates to roughly 14.7

patients after IV alteplase with the modified Rankin scale

million disability-adjusted life years affecting patients aged

(mRS).
20 to 64 years old, with the majority occurring in the
developing countries.3

Methods: This is a cross-sectional study in which patients

receiving IV alteplase in Hospital Universiti Sains Malaysia,
In Malaysia, stroke is one of the top ten causes for

from January 2017 to April 2020 were recruited.

hospitalisation,2 and the mean age of stroke patients in

Demographical data, National Institutes of Health Stroke

Malaysia is 62.5 years.4 With a population of approximately

Scale (NIHSS) scores, door-to-needle time were recorded.

32.5 million in 2019, a majority (69.8%) of them fall into the

Modified Rankin scale (mRS) scores were evaluated at 90

15 to 64 years old age group.5 This increased ageing of the

days after initial therapy. Good and poor functional

population indirectly leads to a higher number of stroke cases

outcomes were defined as 0-2 and 3-6, respectively.

and an associated increase in the healthcare expenditure.

Results: A total of 30 patients were included in the study

Management of acute ischaemic stroke (AIS) had undergone

with a mean age of 59±11.47 years old. 76.7% of them were

three stages of evolution, including the introduction of

male and the rest were female. From the study, onset-to-
intravenous (IV) thrombolysis. Recombinant tissue

needle time was 197.47±51.74 minutes, whereas door-to-

plasminogen activator (rt-PA) is an IV thrombolysis for AIS,

needle time was 120.93±53.63 minutes. Seventeen (56.3%)

was licensed to be used since 1996 following the results from

patients achieved a favourable score of 0-2 on the mRS at 90

the National Institute of Neurological Disorders and Stroke

days after treatment. Haemorrhagic transformation occurred

trials.6 The efficacy of the rt-PA treatment has been shown to

in eight (26.7%) of the patients with a mortality rate of 13.3%.

improve functional outcomes of patients receiving the
therapy within three hours of the onset of the symptoms.

Conclusion: 56.7% of our patients showed improvement in

Functional outcomes of stroke patients are measured with the

the mRS at 90 days post thrombolysis for AIS. Higher

modified Rankin scale (mRS) and a score of 0 to 1 is

baseline NIHSS scores and diabetes mellitus were

considered as a favourable outcome, whereas a score of 0 to

associated with poorer functional outcomes after

2 means that the patient is alive and independent.7,8

thrombolysis.
International guidelines unanimously agreed upon the safe
and effective therapeutic window for treating AIS patients

KEYWORDS:
within 4.5 hours from onset of symptoms.9,10 This study aims
to evaluate the outcomes of AIS patients from January 2017
Acute ischaemic stroke, rt-PA, door-to-needle time, functional to April 2020. The onset-to-needle and door-to-needle time
outcomes, thrombolysis were also analysed.

INTRODUCTION METHODS
Stroke is one of the leading non-communicable diseases that This cross-sectional study was approved by the Human
carry a heavy social and economic impact on individuals Research Ethics Committee of Universiti Sains Malaysia
and their immediate families.1 Thus, it has the most (JEPeM), Kubang Kerian. Data from medical records were
significant burden of disease, based on the disability-adjusted collected from January 2017 to April 2020.

This article was accepted: 31 September 2021

Corresponding Author: Kamarul Aryffin Baharuddin
Email: amararyff@usm.my

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Outcome of acute ischaemic stroke patients after intravenous alteplase in Hospital Universiti Sains Malaysia

The inclusion criteria were all AIS patients who presented diabetes mellitus (33.3%) form the major comorbid suffered
through the Emergency Department (ED) and received IV by these patients. The mean onset time to treatment
alteplase therapy within 4.5 hours of symptoms onset. The (incident-to-needle) was 197.47 minutes (SD±51.74), whilst
demographic data included the age, gender, ethnicity and the door-to-needle time was 120.93 minutes (SD±53.63). All
underlying medical comorbidities of patients. The timing of but one of the patients suffering from a stroke in the
the onset of symptoms to the administration of IV alteplase territories supplied by the middle cerebral artery, with the odd
(incident-to-needle time) and the registration time at the ED one out suffering from a posterior circulation stroke. A mean
to the treatment time (door-to-needle) were also collected. NIHSS score prior to IV alteplase was 10.60 (SD±4.61)
The door-to-needle time is inclusive of assessment, stabilising
and ordering CT scan for the patient from ED, reviewing the The mean mRS during admission was 3.43 (SD±1.331) and
CT scan by the radiologist and neurologist before the there was no significant difference with the mRS of 2.93
administration of the treatment. Comorbidities like diabetes (SD±1.929) at 90 days after the therapy. Figure 1 shows the
mellitus, hypertension, atrial fibrillation and underlying percentages of the patients based on their pre-treatment and
ischaemic heart disease were also included. post-treatment of mRS scores.

Patients received the standard dose of 0.9mg/kg IV alteplase Table II shows a breakdown of all the variables assigned to
(maximum of 90mg). The initial dose of 10% was two different outcomes, one being those with a good outcome
administered as a bolus dose and the remaining 90% was a (mRS 0-2)10 and the other being a poor outcome (mRS 3-6). A
continuous infusion over one hour. Patients’ mRS at the point total of 17 patients (56.7%) had a good outcome (mRS 0-2) at
of treatment were also assessed and compared against their 90 days after the IV alteplase therapy in which 7 (23.3%) of
respective mRS at 90 days post-therapy during follow-up at them were able to return to pre-stroke functional activities.
the Neurology Clinic or telephone interview with the patient Patients with good outcomes have a pre-treatment NIHSS
or caregiver. A mRS of 0-2 was considered as a good clinical score of 9.53 (SD=4.78) compared to 11.89 (SD=4.05) in those
outcome, whereas a score of 3-6 was considered as a poor who had a poor outcome.
outcome.
A total of eight patients (26.7%) developed haemorrhagic
Patients who developed haemorrhagic transformation post- transformation after the IV alteplase of which four (13.3%)
therapy were managed accordingly and classified as a passed away following the insult and four patients recovered
complication of the IV alteplase therapy. Symptomatic or with some functional outcome. Two patients suffered
fatal haemorrhagic transformation is also known as haemorrhagic transformation during the treatment but after
symptomatic intracerebral haemorrhage (SICH). SICH was 90 days, they were able to achieve good outcomes (p=0.049).
defined as local or remote parenchymal haemorrhage within The other four patients (13.3%) who had passed away were
36 hours posttreatment associated with deterioration of four due to hospital-acquired pneumonia, acute coronary event,
points or more based on the National Institutes of Health sepsis and the last patient passed away at home due to
Stroke Scale (NIHSS) or from the lowest NIHSS value between unknown causes, respectively. Table IV shows the breakdown
baseline and 24 hours or leading to death.11 Mortality due to of patients with haemorrhagic transformation according to
other causes was also recorded. year, with zero cases in 2020.

Data of the study was analysed using the IBM SPSS Statistics However, there were no statistically significant outcomes
version 24. The numerical values seen in the tables are between the ages, gender, hypertension, area of infarct,
expressed as mean (standard deviation, SD) and percentages. incident-to-needle, door-to-needle before IV alteplase and the
Association between the variables and functional outcomes functional outcomes after 90 days of patients. Table III shows
were analysed using the independent Student’s t-test, Chi- that for each increment in the pre-treatment NIHSS score,
square or Fisher’s exact test. A p-value of <0.05 was patients had 20% lower odds of achieving a good outcome
considered as statistically significant. To determine the (OR=0.80, 95%CI: 0.640, 0.995). Diabetes mellitus (p=0.034)
predictors of functional outcome, multiple logistic regression and NIHSS scores (p=0.045) have a statistically significant
analysis was performed. association with the functional outcomes.

RESULTS DISCUSSION
The demographic data of the patients recruited during the Thrombolysis in AIS is a relatively new service with limited
study period is shown in Table I. A total of 30 patients experience among physicians in Malaysia, particularly in
received IV alteplase. The duration of the study was Hospital USM. Hospital USM had the stroke thrombolysis
approximately 40 months; hence, the treatment frequency is protocol since 2012 but very few patients had been
less than 1 case per month. Hospital USM (USM) is one of two thrombolysed. With the initiative of the acute stroke team in
centres in the state of Kelantan, Malaysia that offers IV Hospital USM, the number of AIS patients being
alteplase therapy. thrombolysed has increased slowly. Only 23.3% of our
patients achieved a mRS of 0-1 (excellent outcome)7 at 90
Based on Table I, out of the 30 patients enrolled, 23 were days post treatment from our study. This is comparatively
males and seven were females. The mean age of the patients lower than other published data in the Southeast Asia region,
was 59 years old (SD±11.47), with the youngest patient at 36 where the improvement ranges were from 26.1% to 59%.12-15
years of age, whereas the oldest patient was 79 years of age. European studies had achieved excellent outcomes ranging
All the patients were Malays. Hypertension (56.6%) and from 31% to 53%16,17 whereas one study in the United States

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Table I: Baseline characteristics of patients treated with IV rt-PA (n=30)

Characteristics n (%) / mean (SD)
Age (years) 59.0 (11.47)
Gender
Male 23 (76.7)
Female 7 (23.3)
Ethnicity
Malay 30 (100.0)
Mode of transport to ED
By Self 28 (93.3)
By Ambulance 2 (6.7)
Hypertension 17 (56.6)
Diabetes Mellitus 10 (33.3)
Ischaemic Heart Disease 2 (6.7)
NIHSS score pre rt-PA 10.60 (4.61)
Onset-to-treatment time 197.47 (51.74)
Door-to-needle time 120.93 (53.63)
Modified Rankin Scale (Admission)
0-1
0-2 7 (23.3)
3-6 23 (76.7)
Modified Rankin Scale (90 Days)
0-1 7 (23.3)
0-2 17 (56.7)
3-6 13 (43.3)
Modified Rankin Scale at Admission 3.43 (1.331)
Modified Rankin Scale at 90 Days 2.93 (1.929)
Haemorrhagic Transformation 4 (13.3)
Minor haemorrhagic complications 4 (13.3)
Mortality
Due to haemorrhage 4 (13.3)
Other causes 3 (10.0)
Area of Infarct
Left Middle Cerebral Artery 18 (60.0)
Right Middle Cerebral Artery 11 (26.7)
Posterior Circulation 1 (3.3)

Table II: Analysis of factors determining functional outcome

Parameters n (%) / mean (SD) p-value
Good Outcome (n=17) Poor Outcome (n=13)
Age (years) 57.18 (12.98) 61.38 (9.06) 0.328a
Gender 0.666b
Male 14 (46.7) 9 (30.0)
Female 3 (10.0) 4 (13.3)
NIHSS score pre rt-PA 9.35 (4.72) 12.23 (4.09) 0.091a
Onset to Needle (minutes) 190.94 (51.96) 206.00 (52.25) 0.439a
Door to Needle (minutes) 123.41 (64.17) 117.69 (37.95) 0.763a
Haemorrhagic Transformation 0.049c
Yes 2 (6.7) 6 (20.0)
No 15 (50.0) 7 (23.3)
Mortality 0.001c
Death due to SICH 0 (0.0) 4 (13.3)
Death due to other causes 0 (0.0) 3 (10.0)
No 17 (56.7) 6 (20.0)
Hypertension 0.785b
Yes 10 (33.3) 7 (23.3)
No 7 (23.3) 6 (20.0)
Diabetes Mellitus 0.255c
Yes 4 (13.3) 6 (20.0)
No 13 (43.3) 7 (23.3)
Ischaemic Heart Disease 0.492c
Yes 2 (6.7) 0 (0.0)
No 15 (50.0) 13 (43.3)
Ischaemic Area 0.452c
Left MCA 10 (33.3) 8 (26.7)
Right MCA 7 (23.3) 4 (13.3)
Posterior Circulation 0 (0.0) 1 (3.3)
a
independent t-test, bPearson chi-square, cFisher Exact test

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Outcome of acute ischaemic stroke patients after intravenous alteplase in Hospital Universiti Sains Malaysia

Table III: Multiple logistic regression of factors determining functional outcome

Parameter β p-value OR 95% CI
Age -0.04 0.360 0.96 0.88-1.05
NIHSS pre rt-PA -0.23 0.045 0.80 0.64-0.99
DM -2.60 0.034 0.08 0.01-0.82
HPT 1.35 0.214 3.85 0.29-32.36

Table IV: Breakdown of haemorrhagic transformation according to year

Year Haemorrhagic Transformation Total Number of Patients Receiving IV Alteplase
2017 2 6
2018 2 10
2019 4 10
2020 0 4

Fig. 1: Modified Rankin Scale on Admission and at 90 Days post IV rt-PA.

of America had achieved 78.2% of excellent outcome.18 with high serum glucose levels,28 international normalized
However, 56.7% of our patients had a good outcome with ratio (INR) ≥1.028 and history of coronary artery disease or
functional independence (mRS of 0-2). This is comparable atrial fibrillation.29 Many risk factors and predictions have
with another local study at the University of Malaya Medical been proposed for the risk of SICH, including computerised
Centre where 55.6% of their patients had achieved a similar tomography (CT) based scale, MRI-based technique and
outcome.13 plasma biomarkers.22

Many studies trying to predict the functional outcome of AIS In our study, the overall mortality rate at three-month was
patients.19-21 For example, one local study found poor 23.3%, which is higher than regional studies that range from
functional outcome was associated with higher baseline 3.2% to 15.0%.12-15,25 However, SICH as the main cause of
NIHSS scores and the presence of DM.13 On the other hand, death (13.3%) is comparable to another study.30 Our study
one Australian study found that age is a significant predictor also did not explore the risk factors associated with
of good functional outcomes independent of stroke severity.22 haemorrhage, which could be related to various factors such
as the size of cerebral infarct, the ASPECT score at
Symptomatic intracranial haemorrhage (SICH) is a major presentation, late-timing of alteplase infusion or other
complication following thrombolysis.23 In our study, 13.3% of relative contraindications. The pathogenesis of intracerebral
our patients had SICH and this incidence was higher than the haemorrhage after thrombolysis are probably due to pre-
findings of a local study.12,24 A study in Hong Kong had a existing microbleeds and leukoaraiosis, as the majority of
much lower SICH rate of 4%.25 Clinical trials such as NINDS patients had either diabetes or hypertension.23
and ECASS II had 6.4% and 8.8% incidence of SICH.23
Published reports have identified a few risk factors for SICH, The concept of “time is brain”31 has become more significant
such as age more than 70 years old,26 National Institute of as shorter onset-to-needle time is associated with better
Health Stroke Scale (NIHSS) more than 20,27 diabetic patients functional outcomes.32,33 Our onset-to-needle time was

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Original Article

197.47±51.74 minutes, which is longer than the guideline.34 4. National Stroke Registry, Stroke Registry Report 2009-2016 [cited
However, this result is comparable with a Malaysian study Nov 2020]. Available from: https://www.neuro.org.my/wp-
where the mean onset-to-needle time was 211 minutes.13 content/uploads/2019/03/Stroke-registry-report-2009-2016.pdf
5. Department of Statistics, Malaysia. Population distribution and
Studies from Hong Kong and Vietnam had a shorter mean
basic demographic characteristic report 2019 [cited Nov 2020].
onset-to-needle time of 143 minutes,15,25 whereas another Available from: https://www.dosm.gov.my/v1/index.php?
study from Singapore had a median onset-to-needle time of r=column/cthemeByCat&cat=430&bul_id=UDc0eVJ4WEJiYmw0
165 minutes.12 Our door-to-needle time is at 120.93±53.63 Rmt5cjYvWHFkdz09&menu_id=L0pheU43NWJwRWVSZklWdzQ
minutes which is comparable to the Malaysian Stroke 4TlhUUT09
Registry’s time of 132 minutes.4 6. Marler JR, Tilley BC, Lu M, Brott TG, Lyden PC, Grotta JC,
Broderick JP, Levine SR, Frankel MP, Horowitz SH, Haley EC. Early
Nevertheless, the time is still beyond the target in the stroke treatment associated with better outcome: the NINDS rt-PA
stroke study. Neurology 2000; 55(11): 1649-55.
guideline.34 One of the major proponents for reduced
7. Weisscher N, Vermeulen M, Roos YB, De Haan RJ. What should
mortality and improved outcomes is the door-to-needle time. be defined as good outcome in stroke trials; a modified Rankin
Patients receiving IV alteplase within 45 minutes have a score of 0–1 or 0–2? J Neurol 2008; 255(6): 867-74.
lower mortality rate. Conversely. every increment of 15 8. Sharma VK, Tsivgoulis G, Teoh HL, Ong BK, Chan BP. Stroke risk
minutes up to 90 minutes of door-to-needle time is factors and outcomes among various Asian ethnic groups in
significantly associated with worse outcomes.32 Singapore. J Stroke Cerebrovasc Dis 2012; 21(4): 299-304.
9. Hacke W, Kaste M, Bluhmki E, Brozman M, Dávalos A, Guidetti
In order to improve the time to thrombolysis, proven D, Larrue V, Lees KR, Medeghri Z, Machnig T, Schneider D.
Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic
strategies have been identified35 and separated into three
stroke. N Engl J Med 2008; 359(13): 1317-29.
distinct categories: pre-hospital, in-hospital and post- 10. Ahmed N, Wahlgren N, Grond M, Hennerici M, Lees KR, Mikulik
treatment decision strategies. The pre-hospital component is R, Parsons M, Roine RO, Toni D, Ringleb P, SITS investigators.
mainly directed at public education, stroke awareness and Implementation and outcome of thrombolysis with alteplase
early arrival to the hospital. In Malaysia, stroke awareness is 3–4· 5 h after an acute stroke: an updated analysis from SITS-
segregated into urban and rural areas, whilst the city dwellers ISTR. Lancet Neurol 2010; 9(9): 866-74.
are competent in their knowledge36 and the opposite is for 11. Rha JH, Shrivastava VP, Wang Y, Lee KE, Ahmed N, Bluhmki E,
those coming from the rural areas.37 Recognition of stroke Hermansson K, Wahlgren N, SITS Investigators. Thrombolysis for
acute ischaemic stroke with alteplase in an A sian population:
symptoms is one of the crucial keys to early access to medical
results of the multicenter, multinational Safe Implementation of
therapy.38 This is followed by in-hospital strategies inclusive Thrombolysis in Stroke‐Non‐European Union World (SITS‐NEW).
of a fast-track system for thrombolysis.12,39 Easy availability of Intl J Stroke 2014; 9: 93-101.
IV alteplase and simplification of informed consent prior to 12. Sharma VK, Tsivgoulis G, Tan JH, Wong LY, Ong BK, Chan BP, et
treatment at the ED must also be streamlined.35 al. Feasibility and safety of intravenous thrombolysis in
multiethnic Asian stroke patients in Singapore. J Stroke
There are several limitations to our study. Firstly, it is a cross- Cerebrovasc Dis 2010; 19(6): 424-30.
sectional study and information was taken from medical 13. Tai ML, Goh KJ, Kadir KA, Zakaria MI, Yap JF, Tan KS. Predictors
of functional outcome in patients with stroke thrombolysis in a
records and follow-up notes. Thus, interobserver variability of
tertiary hospital in Malaysia. Singapore Med J 2019; 60(5): 236-
the mRS score would remain a substantial bias.40 Secondly, 40.
the small sample size (n=30) from a single-center does not 14. Nilanont Y, Nidhinandana S, Suwanwela NC,
show the complete picture of the disease. Finally, the racial Hanchaiphiboolkul S, Pimpak T, Tatsanavivat P, et al. Quality of
composition of the patients was 100% from the Malay ethnic acute ischemic stroke care in Thailand: a prospective multicenter
group, which does not reflect the national population. countrywide cohort study. J Stroke Cerebrovasc Dis 2014; 23(2):
213-9.
15. Nguyen TH, Truong AL, Ngo MB, Bui CT, Dinh QV, Doan TC,
CONCLUSION Nguyen LT, et al. Patients with thrombolysed stroke in Vietnam
have an excellent outcome: results from the Vietnam
Our study has shown that 56.7% of our patients showed Thrombolysis Registry. Eur J Neurol 2010; 17(9): 1188-92.
improvement in the mRS at 90 days post IV alteplase for AIS 16. Willeit J, Geley T, Schöch J, Rinner H, Tür A, Kreuzer H, et.al.
patients in Hospital USM, which is on par with Malaysian Thrombolysis and clinical outcome in patients with stroke after
reports. However, as a newly established service, we had a implementation of the Tyrol Stroke Pathway: a retrospective
SICH complication rate of 13.3%. In addition, higher baseline observational study. Lancet Neurol 2015; 14(1): 48-56.
NIHSS scores at presentation and the presence of diabetes 17. Walters MR, Muir KW, Harbison J, Lees KR, Ford GA. Intravenous
mellitus were associated with poorer functional outcomes. thrombolysis for acute ischaemic stroke: preliminary experience
with recombinant tissue plasminogen activator in the UK.
Cerebrovasc Dis 2005; 20(6): 438-42.

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