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CARDIOVASCULAR JOURNAL OF AFRICA • Volume 25, No 5, September/October 2014
224
AFRICA
Thrombolysis risk prediction: applying the SITS-SICH
and SEDAN scores in South African patients
A von Klemperer, K Bateman, J Owen, A Bryer
Abstract
At present, the only specific medical treatment for acute
ischaemic stroke is intravenous administration of recombi-
nant tissue plasminogen activator within 4.5 hours of stroke
onset. In the last year, two scores for risk stratification of
intracranial haemorrhage have been derived frommulticentric
European trial groups, the Safe Implementation of Treatment
in Stroke – Symptomatic IntraCerebral Haemorrhage risk
score (SITS-SICH) and the SEDAN score. The aim of this
study was to pilot their use in a cohort of patients treated at a
South African tertiary hospital.
Prospectively collected data were used from a cohort of
41 patients who underwent thrombolysis at Groote Schuur
Hospital from 2000 to 2012. Computerised tomography
brain imaging was available for review in 23 of these cases.
The SITS-SICH and SEDAN scores were then applied and
risk prediction was compared with outcomes.
Two patients suffered symptomatic intracranial haemor-
rhage (SICH), representing 4.9% (95% CI: 0–11.5%) of the
cohort. This was comparable to the SICH rate in both the
SITS-SICH (5.1%) and SEDAN (6.5%) cohorts. Patient
scores in the Groote Schuur Hospital cohort appeared simi-
lar to those of the validation cohorts of both SITS-SICH
and SEDAN.
With increasing use of thrombolysis in a resource-
constrained setting, these scores represent a potentially useful
tool in patient selection of those most likely to benefit from
intravenous thrombolysis, reducing risk for SICH and with
the added benefit of curtailing cost.
Keywords:
stroke, acute ischaemic stroke, thrombolysis, intra-
cranial haemorrhage, risk, SEDAN, SITS-MOST, rTPA, recom-
binant tissue plasminogen activator, Safe Implementation of
Treatment in Stroke – Symptomatic IntraCerebral Haemorrhage
risk score, South Africa, Groote Schuur Hospital
Submitted 24/11/13, accepted 14/8/14
Cardiovasc J Afr
2014;
25
: 224–227
www.cvja.co.zaDOI: 10.5830/CVJA-2014-043
Stroke is the most common cause of death in people over the
age of 50 years in South Africa.
1
It is estimated that there were
approximately 75 000 new cases of stroke in South Africa in
2008. Of these, approximately 25 000 were fatal within the first
28 days. In 2007, there were 350 000 people living with stroke in
South Africa, of whom 35% had moderate to severe disability as
a result of their stroke.
2
Currently, intravenous (IV) administration of recombinant
tissue plasminogen activator (tPA) within 4.5 hours of symptom
onset is the only medical therapy shown to improve outcomes in
acute ischaemic stroke.
3-5
It has become the standard of care in
many international stroke centres.
However, it is still unclear which patients are most likely
to benefit and in what treatment time frame. Initial evidence
demonstrated the benefit of thrombolysis in selected patients
presenting within three hours. It has subsequently been shown
that the window of maximum beneficial effect extends to 4.5
hours.
6,7
Careful selection of patients suitable for thrombolysis
treatment is required to maximise the benefit obtained and offset
the risk of clinical deterioration due to symptomatic intracranial
haemorrhage. Observational data from SITS-MOST show
thrombolysis to be as safe and effective in real clinical practice
as in clinical trials; however, the rate of SICH remained between
1.7 and 4.6%.
8
It has been estimated that of 100 patients treated
with tPA, one will have a severely disabling or fatal outcome due
to tPA-related intracranial haemorrhage.
9
In 2011, Wasserman and Bryer published data on a cohort
of 42 patients treated with tPA at a tertiary hospital in Cape
Town, which showed comparable safety and early outcomes to
similar cohorts in both developed and developing countries.
10
Many clinicians however remain concerned about the use of this
treatment modality and the risk of SICH.
11
Two scoring systems that attempt to stratify patients by
their risk of developing SICH following thrombolysis have
recently been derived from multicentre cohorts of patients – the
Safe Implementation of Treatment in Stroke – Symptomatic
IntraCerebral Haemorrhage risk score (SITS-SICH)
12
and the
SEDAN score.
13
The SITS-SICH score is derived from the
SITS-MOST patient cohort and was internally validated on a
random sample of more than 15 000 patients; it incorporates
primarily clinical variables which best predict the SICH following
thrombolysis with tPA. The SEDAN score is based on both
clinical and radiological findings on computerised tomography
(CT) of the brain, and was externally validated in a smaller
cohort of 828 patients.
Both scores however have been validated in European
populations in developed countries and their utility in a different
setting is not known. Accurate assessment of risk is necessary
for clinicians to select patients who will most benefit from
thrombolytic therapy, at the lowest risk of bleeding complications
such as SICH. In a resource-constrained setting in which the cost
Division of Neurology, Department of Medicine, Groote
Schuur Hospital and University of Cape Town, South Africa
A von Klemperer, MB ChB,
alex.v.klemp@gmail.comK Bateman, MB ChB, MRCP (UK), FC Neurol (SA)
A Bryer, MB ChB, PhD
Department of Radiology, Groote Schuur Hospital and
University of Cape Town, South Africa
J Owen, MB ChB