Research article

International Journal of Stroke

0(0) 1–8
Stroke in the Middle-East and North ! 2019 World Stroke Organization
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Africa: A 2-year prospective sagepub.com/journals-permissions
DOI: 10.1177/1747493019874729

observational study of intravenous journals.sagepub.com/home/wso

thrombolysis treatment in the region.

Results from the SITS-MENA Registry

S Al-Rukn1, M Mazya2,3, N Akhtar4, H Hashim1, B Mansouri5,

B Faouzi6, H Aref7, H Abdulrahman8, S Kesraoui9, F Hentati10,
S Gebelly11, N Ahmed2,3, N Wahlgren3, F Abd-Allah12,
M Almekhlafi13 and T Moreira2,3

Abstract
Background and methods: Intravenous thrombolysis for acute ischemic stroke in the Middle-East and North African
(MENA) countries is still confined to the main urban and university hospitals. This was a prospective observational study
to examine outcomes of intravenous thrombolysis-treated stroke patients in the MENA region compared to the non-
MENA stroke cohort in the SITS International Registry.
Results: Of 32,160 patients with ischemic stroke registered using the SITS intravenous thrombolysis protocol between
June 2014 and May 2016, 500 (1.6%) were recruited in MENA. Compared to non-MENA (all p < 0.001), median age in
MENA was 55 versus 73 years, NIH Stroke Scale score 12 versus 9, onset-to-treatment time 138 versus 155 min and
door-to-needle time 54 min versus 64 min. Hypertension was the most reported risk factor, but lower in MENA (51.7 vs.
69.7%). Diabetes was more frequent in MENA (28.5 vs. 20.8%) as well as smoking (20.8 vs. 15.9%). Hyperlipidemia was
less observed in MENA (17.6 vs. 29.3%). Functional independence (mRS 0–2) at seven days or discharge was similar (53%
vs. 52% in non-MENA), with mortality slightly lower in MENA (2.3% vs. 4.8%). SICH rates by SITS-MOST definition were
low (<1.4%) in both groups.
Conclusions: Intravenous thrombolysis patients in MENA were younger, had more severe strokes and more often
diabetes. Although stroke severity was higher in MENA, short-term functional independency and mortality were not
worse compared to non-MENA, which could partly be explained by younger age and shorter OTT in MENA. Decreasing
the burden of stroke in this young population should be prioritized.

Keywords
Ischemic stroke, hemorrhagic stroke, door-to-needle, door-to-imaging, burden of stroke

Received: 1 April 2019; accepted: 24 June 2019

9
Department of Neurology, CHU de Blida – Hôpital Franz Fanon, Blida,
Algeria
10
1
Department of Neurology, Rashid Hospital – Dubai Health Authority, Department of Neurology, Mongi Ben Hamida National Institute of
Dubai, United Arab Emirates Neurology, Tunis, Tunisia
11
2
Department of Neurology, Karolinska University Hospital, Stockholm, Faculty of Medical Sciences – Lebanese University, Neurology Division,
Sweden Hadath, Lebanon
12
3
Department of Clinical Neurosciences, Karolinska Institutet, Stockholm, Department of Neurology, Cairo University, Cairo, Egypt
13
Sweden Department of Neurology, King Abdulaziz University, Jeddah, Saudi
4
Hamad General Hospital, Section of Neurology, Doha, Qatar Arabia
5
Department of Neurology, Imam Husain Hospital, Tehran, Iran Corresponding author:
6
Department of Neurology, Hassan II University Hospital, Fez, Morocco T Moreira, Tema Neuro/Dept of Neurovascular Diseases, Karolinska
7
Ain Shams University, Stroke Unit, Cairo, Egypt University Hospital, Eugeniavägen 6, Carolina Tower 3rd floor,
8
Department of Neurology, King Abdulaziz Medical City, Riyadh, Saudi Stockholm 17176, Sweden.
Arabia Email: tiago.more@gmail.com

International Journal of Stroke, 0(0)

2 International Journal of Stroke 0(0)
Introduction
The dissemination of intravenous thrombolysis (IVT)
for acute ischemic stroke in the countries of the
Middle East and North Africa (MENA) has rapidly
grown in recent years. This has been supported by
increased financing from health authorities and support
from the European Stroke Organisation (ESO) Angels
initiative but is still limited to university hospitals and
centers with large urban catchment areas.1–5 The SITS
MENA network, created in 2013, is a non-profit aca-
demic collaboration of researchers who use the SITS
Registry platform. Its goal is supporting the dissemin-
ation of evidence-based treatments in a region where
stroke incidence is high and rising, as well as monitor
the implementation and outcomes of acute stroke treat-
ments in MENA. World Health Organization
Projections suggest that deaths from stroke will nearly
double in the MENA region by 2030.6 In a recent study
of stroke patient characteristics in participating SITS
MENA hospitals, we found hypertension and diabetes
to be the prevailing risk factors; and large artery sten-
osis >50% and lacunar strokes to be the main etiolo-
gies for ischemic stroke, while hemorrhagic strokes
were somewhat less frequent in MENA compared to
non-MENA countries.7 The aims of the present study
were to expand our observations to clinical character-
istics, safety and outcomes of IVT-treated stroke
patients in the MENA region compared to the non-
MENA cohort in the SITS International Registry.
Methods
This was a prospective, observational, register-based,
two-year study conducted between 1 June 2014 and
31 May 2016 led by the Safe Implementation of
Treatments in Stroke (SITS) MENA network. SITS
has been a prospective, multinational, register platform
for medical centers documenting stroke treatments
since 2002. The SITS IVT protocol-minimal version
(IVTP-minimal) was adopted as the IVT stroke registry
for the MENA region in 2014. The aims of the registry,
collection of data, and structure of the database have
been previously described.7,8 The participating MENA
countries were Algeria, Egypt, Iran, Lebanon,
Morocco, Qatar, Saudi Arabia, Tunisia and the
United Arab Emirates. The participating non-MENA
countries were Albania, Argentina, Australia, Belgium,
Brazil, Bulgaria, Chile, China, Costa Rica, Croatia,
Czech Republic, Estonia, Finland, Germany, Greece,
Honduras, Hungary, India, Ireland, Israel, Italy,
Kyrgyzstan, Lithuania, F.Y. Republic of Macedonia,
Moldova, New Zealand, Norway, Panama, Peru,
Philippines, Poland, Portugal, Russian Federation,
Singapore, Slovakia, Slovenia, Spain, Sri Lanka,
International Journal of Stroke, 0(0)
Sweden, Switzerland, Thailand, Turkey, Ukraine,
United Kingdom, Uruguay and Venezuela. Only hos-
pitals having high standard stroke management, an
urban uptake area, and capacity to perform the basic
documentation for the study were invited to partici-
pate, as determined by each country’s national coord-
inator for SITS. High standard stroke management for
the present study was defined as hospital clinics or
departments admitting patients in the acute phase of
stroke under the supervision of the head of the stroke
unit and/or responsible for stroke management. These
hospitals were required to have dedicated stroke units
or additional beds for stroke patients in a general ward
managed by a stroke physician, acute head CT or MRI
scan, and intravenous tPA availability. A total of 13
centers joined the study, varying from 1 to 3 centers
in each country.
Patient inclusion
All patients treated with IVT in these selected centers
for acute ischemic stroke were included. The patients
were managed by a stroke physician in a stroke unit or
in dedicated stroke beds of a general ward. Data for
non-MENA countries are provided for comparison.
The IVT minimal data entry form includes logistics
(time of stroke onset, arrival at hospital, IVT dose,
time and duration), age, gender, NIHSS score, modified
Rankin scale (mRS) score before stroke onset, treat-
ments at stroke onset (antiplatelets, oral anticoagu-
lants, statin, non-steroidal anti-inflammatory drugs,
other treatment) risk factors (both known and newly
discovered), glucose, blood pressure, imaging CT/MR
(time, presence of visible infarct at baseline as well as
intracranial hemorrhage of three radiological types at
follow-up: hemorrhagic infarction, with petechia within
or at the infarction margin but without mass effect;
parenchymal hemorrhage with mild to significant
space-occupying effect and extra-ischemic remote par-
enchymal hemorrhage, uni- or multifocal), treatments
during hospital stay and at discharge, discharge logis-
tics (e.g. own home, other acute clinic, geriatric/
rehabilitation, other stroke unit, unknown), stroke/
TIA diagnosis (ICD-10 subtypes I63.0, I63.3, I63.4,
I63.5, I63.6, I63.8, I63.9, G45.0, G45.1, G45.2, G45.3,
G45.9, I61.0, I61.1, I61.2, I61.4, I61.5, I61.6, I61.8,
I61.9, and I60.9), functional outcome assessed by
mRS and death, within seven days, at discharge and
at three months; and new event within three months
(new stroke, seizure, myocardial infarction, pneumonia,
pulmonary embolism, other). All assessments of ima-
ging studies, neurological status, and functional out-
comes were done according to clinical routine at
participating centers.
Al-Rukn et al.
Outcome analysis
Outcomes were compared with international data in
SITS (labelled as non-MENA countries).
Symptomatic intracranial hemorrhage (SICH) was
measured using the SITS-Monitoring Study (SITS-
MOST), the European Cooperative Acute Stroke
Study (ECASS II), and the National Institute of
Neurological Diseases and Stroke (NINDS) defin-
itions.9 The SITS International Coordination Office
monitored the registry data online and checked individ-
ual patient data monthly to identify errors or inconsis-
tencies. For continuous and ordinal variables,
differences in median and interquartile range (IQR)
values were compared between groups using the
Mann–Whitney U test. For categorical variables, we
calculated percentage proportions by dividing the
number of events by the total number of patients,
excluding missing or unknown cases, as done in previ-
ous SITS publications, using Pearson Chi2 for signifi-
cance testing.10,11
Ethical approval
Ethics approval was obtained from the Stockholm
Regional Ethics Committee for this project as part of
the SITS-MOST (Safe Implementation of
Thrombolysis in Stroke Monitoring Study) II frame-
work. The need for ethical approval and patient con-
sent for participation in the SITS-ISTR varied among
enrolling countries. They were obtained in countries
requiring so; other countries approved the registry for
conduct as an anonymized audit. Data required for this
study can be made accessible upon request to the SITS
International Coordinating Office (www.sitsinterna-
tional.org).
Results
Patient characteristics and workflow metrics are pre-
sented in Table 1. Patients treated with IVT were sig-
nificantly younger in MENA countries (median 55 vs.
73 years old, p < 0.001). They also presented with more
severe strokes compared to non-MENA (median
NIHSS 12 vs. 9, p < 0.001). Male patients were more
often treated with IVT in both groups, with a wider
gender difference in the MENA countries. Systolic
blood pressure at baseline was lower in MENA than
in non-MENA patients (median 140 vs. 152 mmHg,
p < 0.001). Blood glucose at baseline was also higher in
MENA patients (median 7.0 vs. 6.7 mmol/L, p ¼ 0.009).
Slightly shorter onset-to-treatment, onset-to-door, door-
to-needle, and door-to-imaging times were recorded in
MENA patients (see logistics in Table 1).
3
Risk factors at stroke onset (Figure 1)
MENA patients had significantly more often diabetes
(28.5 vs. 20.7%, p < 0.001) and were more often current
smokers than non-MENA patients (20.8 vs. 15.9%,
p ¼ 0.004). Non-MENA patients had significantly
higher rates (all p < 0.001) of atrial fibrillation (19.4
vs. 8.8%), hypertension (69.7 vs. 51.7%), hyperlipid-
emia (29.3 vs. 17.6%), previous smoking (11.5 vs.
5.6%), and previous stroke older than three months
(10.5 vs. 4.4%). There was no difference in heart failure
rates and the occurrence of previous stroke within the
last three months between MENA and non-MENA
patients.
Anti-platelet treatment at baseline
A significantly higher proportion of patients in the non-
MENA countries was on aspirin treatment at stroke
onset when compared to MENA (31.0 vs. 19.8%,
p < 0.001). There was no difference regarding clopido-
grel treatment.
Computerized tomography on admission
Dense artery sign was more frequently detected in
MENA patients (26.4 in MENA, n ¼ 390 vs. 21.4% in
non-MENA, n ¼ 26,608; p ¼ 0.005), whereas the pres-
ence of visible acute infarct on CT did not differ
between the two groups.
SICH (Table 2)
A slightly significant higher rate of SICH as per
NINDS definition was detected in the non-MENA
patients (5.6 vs. 3.3%, p ¼ 0.03). However, SICH
rates as per ECASS-II and SITS-MOST definitions
did not significantly differ between MENA and non-
MENA patients.
Functional outcomes at seven days or at discharge
(Figure 2)
MENA and non-MENA patients had similar levels of
functional independence (mRS 0–2; 53 vs. 52%,
p ¼ 0.53). Mortality at this timepoint was slightly
lower in the MENA group (2.3 vs. 4.8%, p ¼ 0.013).
However, the proportion of cases with available
data on mRS and death at seven days or discharge
was 94.5% for MENA patients and 72.4% for
non-MENA patients, limiting the value of the
comparisons above. Similarly, there was not enough
data available for a reliable three-month follow-up
analysis.
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4 International Journal of Stroke 0(0)

Table 1. Baseline patient characteristics and hospital logistics

MENA (n ¼ 500) Non-MENA (n ¼ 31,660)

Median (IQR) Median (IQR)

Patient characteristics Valid n or % Valid n or % p value

Age, years 499 55 (47–67) 31,611 73 (63–80) <0.001

NIHSS 487 12 (8–16) 27,344 9 (6–16) <0.001

Sys BP (mmHg) 471 140 (130–160) 26,558 152 (138–170) <0.001

Dia BP (mmHg) 471 85 (80–90) 26,551 82 (75–91) 0.001

Glucose (mmol/L) 453 7.0 (5.9–9.0) 25,607 6.7 (5.8–8.2) 0.009

Male 360 72% 16,987 53.6% <0.001

Female 140 28% 14,673 46.4% <0.001

Male NIHSS 328 12 (8–15) 11,580 9 (5–15)

Female NIHSS 108 14 (10–18) 9974 11 (6–17)

p value 0.004 < 0.001

Logistics (min)

OTT 268 138 (110–181) 25,487 155 (117–205) <0.001

OTD 237 75 (60–120) 27,210 80 (55–120) 0.70

DNT 230 54 (39–69) 24,580 64 (41–95) <0.001

DIT 397 17 (12–30) 18,426 25 (15–40) <0.001

Sys: systolic; Dia: diastolic; OTT: onset-to-treatment; OTD: onset-to-door; DNT: door-to-needle time; DIT: door-to-imaging time

Figure 1. Risk factors at stroke onset of IVT-treated patients.

International Journal of Stroke, 0(0)

Al-Rukn et al.
Table 2. Symptomatic intracranial hemorrhage (SICH) rates
1 MENA % Non-MENA
SITS-MOST 5/488 1.0
ECASS II 12/460 2.6
NINDS 15/461 3.3
SICH: symptomatic intracranial hemorrhage; SITS-MOST: SITS-monitoring study; ECASS II: European Cooperative Acute Stroke Study; NINDS:
National Institute of Neurological Diseases and Stroke.
Figure 2. Functional outcome at seven days or discharge.
mRS: modified Rankin scale.
Destination after discharge from hospital
(Figure 3)
Most MENA patients (73.6%) were discharged to their
own homes compared to non-MENA patients (47.7%).
Thus, MENA patients were also less often discharged
to geriatric or rehabilitation units (7.9 vs. 22.8%), spe-
cial facilities (4.6 vs. 8.3%), and other acute clinics/
units (0 vs. 6%). Patients in MENA were also dis-
charged dead less often than in non-MENA countries
(6.5 vs. 9.6%, all p < 0.001). The mortality rates above
include the cumulative mortality rates at seven days
and beyond.
Discussion
In MENA hospitals participating in the SITS Registry,
IVT was predominantly given to relatively young,
mostly male patients. During the study period of
2014–2016, treatment was delivered in centers with
logistic metrics similar (and somewhat better) to
European centers participating in the original SITS-
MOST study in 2002–2006. Specifically, in SITS-
MENA, DNT was 54 min versus 64 in SITS-MOST,
OTT 138 min in MENA versus 140 min in SITS-
MOST. This is coupled to identical median stroke
5
% p value (univariate)
360/25,795 1.4 0.49
976/24,786 3.9 0.15
1390/24,851 5.6 0.030
severity between the MENA cohort and the 10-year
earlier SITS-MOST, at NIHSS 12 in both studies.
This comparison of cohorts a decade apart has rele-
vance, as the novelty of IVT in clinical practice in
MENA in 2014–2016 is comparable to that in
European centers in 2002–2006.8
The higher occurrence of more severe strokes in the
IVT MENA population is in contrast with the rela-
tively lower burden of risk factors at baseline in these
patients when compared to non-MENA patients,
exception made to more frequent diabetes and ongoing
smoking in MENA. The higher occurrence of diabetes
in IVT-treated MENA patients (28.5% vs. 20.7% in
non-MENA) is in line with our previously reported
findings in the general stroke population in the SITS
MENA Registry.7 Hypertension in IVT-treated MENA
patients is less common compared to IVT-treated non-
MENA patients (51.7 vs. 69.7%), possibly explained by
their younger age or underdiagnosed. In our previous
SITS MENA study, atrial fibrillation was shown to be
less frequent and probably underdiagnosed in an older
cohort of stroke patients. 7 However, IVT-treated
MENA patients in this study are younger and atrial
fibrillation is known to be more prevalent with older
age.12 Thus, a possible explanation for the more severe
strokes observed in the IVT-treated MENA patients
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6 International Journal of Stroke 0(0)
Figure 3. Destination after discharge from hospital.
despite the lower risk factor burden is the higher preva-
lence of intracranial stenoses in the region, which may
increase stroke severity, occur at a younger age, and
explain the higher frequency of dense vessel signs in
the MENA patients.13,14 The general SITS-MENA
stroke population study also showed large-vessel sten-
osis > 50% to be a common stroke etiology.7 There
were fewer women than men receiving IVT in both
MENA and non-MENA countries. This pattern was
seen in a previous SITS IVT study in predominantly
European patients in 2002–2011.15 Our previous SITS
MENA study of general stroke patients also showed
fewer women than men in the cohort, with a wider
gender gap in the MENA versus the non-MENA popu-
lation.7 Similarly, a study from Qatar showed that 79%
of all stroke patients were male and that almost half of
them were 50 years or less, which is in line with the
present study population.4 Despite comparable age
and gender profiles in previous studies, it is important
to mention that pre-or in-hospital patient selection
could have resulted in younger male patients being trea-
ted with IVT, in the past and in the present study.
SICH
SICH rates as per ECASS II and SITS-MOST were low
(ranging from 1% to 3.9%) and comparable between
MENA and non-MENA patients. A reasonable
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explanation is that most of MENA patients are in
their 50s but have more severe strokes, whereas non-
MENA patients are in their 70s but have milder
strokes, thus balancing these groups regarding bleeding
risk. Indeed, older age and more severe strokes are
known risk factors associated with SICH.16,17
Functional outcomes at seven days or discharge
The proportion of functionally independent patients
was comparable between MENA and non-MENA,
with slightly over half of the patients presenting with
mRS 0–2 at seven days or at discharge in both groups.
There was slightly lower mortality in the MENA region
which may relate to the younger population; however,
follow-up data are lacking in a substantial proportion
of non-MENA patients warranting caution in inter-
pretation. Given the high average stroke severity in
the MENA IVT cohort, we saw a notably low propor-
tion of patients discharged to rehabilitation clinics.
More often, patients were discharged to their own
homes, which is a traditional standard of care in this
region. This was in line with our previous MENA study
and a separate study from Lebanon.3,7 The short-term
follow-up in our study does not yet reflect any long-
term effects of discharge to home versus rehabilitation
units on outcomes. Additional resources and improved
logistics are necessary to achieve high stable rates of
Al-Rukn et al.
long-term follow-up. Mobile phone follow-up at three
months could be a feasible alternative. A previous pilot-
study from our research group showed 83% agreement
between mobile phone and clinical-based mRS assess-
ment in separating functional independence mRS 0–2
from functional dependence (mRS 3–5).18 Planned
endovascular treatment studies using the SITS
Thrombectomy protocol (SITS-TBY) in the MENA
region may incentivize performance and data collection
from structured three-month follow-up at comprehen-
sive stroke centers.
Finally, factors influencing general accessibility to
IVT treatment in MENA countries need to be con-
sidered. For instance, in Iran, the major obstacles to
timely treatment of acute ischemic stroke were identi-
fied to be low public awareness, low priority for acute
stroke care and insufficient amount of stroke ready hos-
pitals, including lack of 24/7 access to endovascular
therapy.5 Inadequate knowledge in emergency service
workers about stroke types, symptoms and mimics was
also found in Dubai, which led to an effective educa-
tional initiative.19 However, a success story of IVT dis-
semination can be told for Egypt, which uses SITS for
the Egyptian Stroke National Registry with the support
of the ESO Angels Initiative. IVT rates across 52
Egyptian centers increased from 2% to 4.5% just two
years after the conclusion of data collection for the pre-
sent study.1,20
Conclusions
Experience with IVT treatment is increasing in MENA
countries. Our observational study reveals the treated
population to be a relatively young, predominantly
male, presenting commonly with diabetes and ongoing
smoking. Wider implementation of IVT treatment,
improved risk factor control, access to rehabilitation
and long-term follow-up need to be incentivized and
supported by health authorities. Without this, the pre-
dicted rise in the burden of stroke is unlikely to be
halted in the MENA countries.
Acknowledgements
The authors thank Carla Zeid, Dubai, for excellent develop-
ment and support to the MENA network. Dr Shekhar
Ghotoskar for valuable input for the MENA network collab-
oration. A list of national and local coordinators of the SITS
MENA network is provided in our previous publication.7
Declaration of conflicting interests
The author(s) declared the following potential conflicts of
interest with respect to the research, authorship, and/or pub-
lication of this article: MV Mazya holds the position of
Researcher at SITS International, N Ahmed is the
Chairman (2019) of SITS International and N Wahlgren
7
was Chairman (1996-2018) and now senior advisor of SITS
International, which received an unrestricted grant from
Boehringer Ingelheim for the SITS-ISTR. T Moreira has
received travel and speaker grants from Boehringer-
Ingelheim. M Almekhlafi received travel and speaker grants
from Boehringer-Ingelheim.
Funding
The author(s) received no financial support for the research,
authorship, and/or publication of this article.
ORCID iD
T Moreira https://orcid.org/0000-0002-7613-5169
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