National Stroke Strategy

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National Stroke Strategy SITS

• Don Sims

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(No Transcript)
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National Stroke Strategy

• Every year approximately 130,000 people in
  England have a stroke
• Stroke is the third largest cause of death in
  England
• 11 per cent of deaths in England are as a result
  of stroke
• 2030 per cent of people who have a stroke die
  within a month
• 25 per cent of strokes occur in people under the
  age of 65
• Stroke is the single largest cause of adult
  disability
• 300,000 people in England live with moderate to
  severe disability as a result of stroke
• Ethnic minorities are at higher risk of stroke

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Why the need for a strategy?

• National Sentinel audit for stroke confirmed a
  steady improvement in care
• But unfortunately the UK is still lagging behind
  the rest of the European Union
• Stroke care in the UK appears to be
• More expensive
• With longer lengths of stay
• And with poorer outcomes both in mortality and
  disability

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A Common Consensus

• Specialist stroke units
• Regarding acute stroke as an emergency
• Rapid access to services for people who have had
  a TIA
• Immediate access to diagnostic scans and to
  thrombolysis for patients whose stroke was caused
  by a clot
• Early supported discharge for people with
  moderate disability as a result of stroke
• More emphasis on prevention and public awareness
• Better support for all people living with stroke
  in the long term

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Patients per year in UK who avoid death or
dependence with each treatment?
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Barriers to rapid acute stroke care

• 60 of patients would contact their GP or NHS
  Direct if having a stroke
• Only 33 of patients would call an ambulance or
  go to hospital
• 20 of GPs said they do not refer around a fifth
  of cases of a TIA or stroke
• Just over half of GPs said they would refer
  someone with a suspected stroke immediately

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Thrombolysis in the strategy

• lt 12 of hospitals have protocols in place with
  ambulance services for the rapid referral of
  those with suspected stroke
• lt 50 of hospitals with acute stroke units have
  access to brain scanning within three hours of
  admission to hospital
• Less than 1 of patients with ischaemic stroke
  received thrombolysis in 2006

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A target-free strategy?

• All patients with suspected acute stroke are
  immediately transferred by ambulance to a
  receiving hospital providing hyper-acute stroke
  services
• Where a stroke triage system, expert clinical
  assessment, timely imaging and the ability to
  deliver intravenous thrombolysis are available
  throughout the 24-hour period

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What has needed to change?

• Ambulance crews identifying and pre-alerting
  patients to the ED / Stroke team
• ED identifying suitable patients rapidly to allow
  delivery of thrombolysis
• Radiology agreement to immediate CT scan of
  suitable patients (not all stroke patients?)
• Availability of continuous monitoring for treated
  patients in a hyper-acute stroke unit

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What has needed to change?

• Training for staff to deliver the treatment to
  the correct 10-20 of stroke patients
• Currently in the UK about 200 WTE consultant
  stroke physicians
• Probably a little under half the number needed by
  workforce estimates
• How is 24 hour thrombolysis deliverable in the
  NHS?

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Who delivers the service?

• National Strategy
• thrombolytic treatment must be performed by a
  physician specialised in neurological care.
• Consider hub and spoke models
• But 1.9 million neurones lost per minute
• Time is brain!
• Concerns about transfer times across cities /
  ambulance crews incorrectly selecting hospitals
  to take patient to.
• Telemedicine?

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Who delivers the service?

• Comments from NICE
• in the UK, physicians with experience in
  stroke care are not always the same as those
  specialised in neurological care. The Committee
  concluded that alteplase should be used by a
  physician trained and experienced in the
  management of acute stroke
• Comments from DoH
• Will centrally fund 10 additional CCTs in Stroke
  Medicine in the UK

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Who delivers the service?

• Comments from the BASP
• rotas for thrombolysis may include acute
  physicians, general physicians and emergency
  department consultants with the requisite
  training and experience.
• Provided one can see enough to maintain the
  necessary expertise
• Responsibility of the monitoring, supervision and
  regulatory requirements (SITS registration) for
  thrombolysis patients will remain with the stroke
  physician

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Who delivers the service?

• In practice most thrombolysis is delivered by a
  combination of consultant geriatricians and
  neurologists (with SpRs)
• A minority of smaller trusts
• Either utilise ED staff
• Or the medical on-call team
• Key is that thrombolysis is delivered by staff
• Familiar with stroke and stroke mimics
• Good awareness of ongoing care and complications
  of acute stroke

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Some thoughts on service delivery

• Maintaining expertise
• Assuming 10 of strokes are treated
• Around 45 cases a year with a 24 hour service
• Stroke team retains 9-5 responsibility
• 20 cases a year out of hours
• Someone on a 1 in 10 rota would
• Treat about 2 a year and assess maybe 6
• Sharing of experience likely to be beneficial and
  rotas with 15 or 20 participants may struggle to
  maintain expertise

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Stroke thrombolysis

• Will likely remain a service delivered by small
  groups of fairly senior doctors
• Seems unlikely to ever be delivered by very
  junior members of staff on 4 month rotations
• And will need to have regular (even if only
  yearly) feedback meetings to discuss cases

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Evidence for Thrombolysis
NINDS Trial and the SITS database
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Stroke Thrombolysis

• Initial NINDS trial published in 1995
• Widespread adoption of alteplase in USA,
  Australia and Scandinavia by 2000
• Most UK centres set up within the last 4 years
• NICE Technology Appraisal in June 2007
• Approval of alteplase for acute ischaemic stroke
  within 3 hours

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Definitions The NIHSS Score

• NIHSS (National Institute for Health Stroke
  Scale)
• 42 point scale with 0 as no deficit
• Measures neurological deficit in 11 domains
• Mild facial weakness scores 1
• Complete hemiparesis with dysphasia, dysarthria,
  hemianopia and sensory loss scores 25
• Patients with a score of between 5 and 25
  inclusive are treated with alteplase

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Definitions The NIHSS Score

• Zero does not necessarily mean no neurological
  deficit using the MRC scale
• Some assumptions are made
• Inability to determine often means score is 0
• If conscious level domain score is 3 than certain
  other scores are fixed
• Used both to assess a patients suitability for
  treatment and to monitor subsequent progress

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Definitions Rankin Score

• (Modified) Rankin Score is a 6 point scale
• Measures functional ability / independence
• 0 is free from disability and fully independent
• 1 is mild disability but still independent
• 5 is fully dependent, bed fast and all care
• 0-1 is often used as a marker of a positive
  outcome
• Patients with a score of 3 or more are often
  excluded from treatment with alteplase

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National Institute of Neurological Disorders and
Stroke (1995)

• Alteplase given to patient with a clear clinical
  diagnosis of stroke
• Within 3 hours of onset of symptoms
• Following CT head to confirm no haemorrhage
  present
• Patients aged 18-80
• Symptoms present for at least 30 minutes
• Large number of other exclusion criteria

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National Institute of Neurological Disorders and
Stroke (1995)

• Part 1 (291 patients) looked at clinical
  improvement at 24 hours
• Part 2 (333 patients) looked at functional
  outcome at 3 months
• No significant difference at 24 hours (Part 1)
• Alteplase associated with an increase in
  intracranial haemorrhage (6.4 vs. 0.6)
• Alteplase associated with a 30 increase in
  chance of either none or minimal disability (mRS
  of 0-1)
• Alteplase associated with small non-significant
  reduction in mortality (p0.30)

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NINDS Trial - 3 Month Outcome
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Stroke Thrombolysis

• Placebo-controlled trials of thrombolysis in
  acute stroke
• Total (all agents) (2005) 5,675
• Alteplase (2005) 2,700
• of which only 42 aged gt 80 years

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Comparison tocardiac thrombolysis

• Placebo-controlled trials of thrombolysis in
  acute myocardial infarction
• GISSI (1986) 12,000
• ISIS-2 (1988) 17,000
• ASSET (1988) 13,300
• Total by end 1988 43,300

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SITS Safe Implementation of Thrombolysis in
Stroke

• www.acutestroke.org

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SITS

• Online registration of all patients that receive
  thrombolysis for acute stroke in Europe
• Allows detailed post-marketing surveillance
• Monitors outcomes and compares results of
  treatment (protocol vs. non-protocol)
• Produces reports comparing all centres /
  countries
• Expanding to allow other treatments to be entered
• Intra-arterial thrombolysis
• Craniectomy

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Evidence base for alteplase

• Limited number of trials
• Heavily reliant on a single trial
• NINDS (1995)
• If whether in practice alteplase was as effective
  as within the trial was unknown
• Huge national variation in the care of stroke
  patients from critical care to general medical
  wards

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What has SITS taught us?

• Proposed benefits appear achievable in real
  life clinical context
• That protocol violations (generally) result in
  more cerebral haemorrhages
• That new centres do not have a higher mortality
  than established centres
• That there may be a role for treatment above 3
  hours (but not more than 6 hours)

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And gives scope for further research
Current License
ECASS III
IST - 3
odds ratio
Confidence limits
3 hours
6 hours
Stroke onset to treatment time (minutes)
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SITS Data
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Global Outcomes
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Door to Needle Times
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Potential for reduction in exclusion criteria?

• Current exclusion criteria / warning for those gt
  80 years
• But meta-analysis of 6 studies n2,224, 477 gt
  80yrs (Engelter) in 2006
• No difference in risk of ICH between young and
  old
• More older patients were dead (21 vs. 5) at 3
  months in the older group
• Fewer older people achieved a favourable outcome
  (26 vs. 47)
• Since age is one of the strongest predictors of
  outcome after stroke, poorer outcome in older
  people is not unexpected
• Evidence from randomized trials is needed, but
  until then appears there is no good reason to
  withhold alteplase from older individuals

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Conclusions

• National strategy has highlighted that importance
  of thrombolysis in the delivery of comprehensive
  acute care
• Recommendation that this should be available 24
  hours a day though hurdles highlighted not solved
• SITS is an important part of thrombolysis
  surveillance to support and guide future treatment

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Any Questions?