evidence based stroke update 2017...anderson cs et al. n engl j med 2017;376:2437-2447...
TRANSCRIPT
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Evidence Based Stroke Update
2017
Ajay Bhalla
Guy’s and St Thomas’ Hospitals
UK Stroke Forum
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Future is hard to predict…..
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Future is hard to predict…..
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Future is hard to predict…..
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Future is hard to predict…..
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Future is hard to predict…..
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Lecture Outline
Early Rehabilitation
Secondary Prevention
Intra-arterial interventions
Organised stroke care
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Optimal Head Position
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What does the Guideline say?
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Original Article
Cluster-Randomized, Crossover Trial of Head Positioning in Acute Stroke
Craig S. Anderson, M.D., Ph.D., Hisatomi Arima, M.D., Ph.D., Pablo Lavados, M.D., M.P.H., Laurent Billot, M.Res., Maree L. Hackett, Ph.D., Verónica V. Olavarría, M.D., Paula Muñoz
Venturelli, M.D., Ph.D., Alejandro Brunser, M.D., Bin Peng, M.D., Liying Cui, M.D., Lily Song, M.D., Ph.D., Kris Rogers, M.Biostat., Ph.D., Sandy Middleton, Ph.D., Joyce Y. Lim, M.Nurs., Denise Forshaw, PG.Cert., C. Elizabeth Lightbody, Ph.D., Mark Woodward, Ph.D., Octavio Pontes-
Neto, M.D., H. Asita De Silva, D.Phil., Ruey-Tay Lin, M.D., Tsong-Hai Lee, M.D., Ph.D., Jeyaraj D. Pandian, D.M., Gillian E. Mead, M.D., Thompson Robinson, M.D., Caroline Watkins, Ph.D., for the
HeadPoST Investigators and Coordinators
Examine the effects of lying flat compared with sitting up head positioning in the first 24 hours of hospital admission for patients with acute stroke
N Engl J MedVolume 376(25):2437-2447
June 22, 2017
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Anderson CS et al. N Engl J Med 2017;376:2437-2447
Characteristics of the 11,093 Patients with Acute Stroke at Baseline.
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Intervention Effects in the Lying-Flat Group and the Sitting-Up Group at 90 Days, According to Modified Rankin Scale Score.
Anderson CS et al. N Engl J Med 2017;376:2437-2447
Odds ratio: 1.01; 95 CI: 0.92 to 1.10; P=0.84
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Safety
14
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Implications
• Question the generalisability (mild strokes,
presented late)
• No data on perfusion/penumbra size
• Patients with large vessel occlusion could
benefit from a positional strategy
• Perhaps individualised approach is required as
no clear benefit or harm
• Lying flat: is not harmful
• Guidelines need to reflect this.
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Early Rehabilitation
Secondary Prevention
Intra-arterial interventions
Organised stroke care
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PFO and Stroke
20-30% of ischaemic stroke: cryptogenic
Mechanism: Paradoxical Embolism
3 fold increase in recurrent stroke
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PFO and Stroke
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Negative Results
• Low event rate
• High risk patients not being randomised
• Definition of Cryptogenic stroke not
standardised
• Devices: older
• Follow up was short with few patients
• Not everyone had imaging
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What does the Guidelines Say?
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Original Article
Long-Term Outcomes of Patent Foramen Ovale Closure or Medical Therapy after Stroke
Jeffrey L. Saver, M.D., John D. Carroll, M.D., David E. Thaler, M.D., Ph.D., Richard W. Smalling, M.D., Ph.D., Lee A. MacDonald, M.D., David S. Marks, M.D., David L.
Tirschwell, M.D., for the RESPECT Investigators
Patients who had a cryptogenic stroke and a PFO were randomly assigned to PFO closure (499) or medical therapy (481) with a median follow up (5.9 years)
Patients who had had a cryptogenic stroke and had a PFO were randomly assigned to medical therapy or PFO closurN Engl J Med
Volume 377(11):1022-1032September 14, 2017
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Recurent ischaemic stroke: PFO 18 (3.6%) vs Medical 28 (5.8%)
NNT: 43 to prevent 1 recurrent stroke over 5 years
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Rate of Recurrent Ischemic Stroke According to Subgroup.
Saver JL et al. N Engl J Med 2017;377:1022-1032
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Serious Adverse Events Related to the Procedure or Device among the 499 Patients in the PFO Closure Group.
Saver JL et al. N Engl J Med 2017;377:1022-1032
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Original Article
Patent Foramen Ovale Closure or Anticoagulation vs. Antiplatelets after Stroke
On behalf of CLOSE Investigators
Comparing PFO Closure after Cryptogenic stroke or antiplatelet vs anticoagulationIn patients with atrial septal aneurysm or large interatrial shunt (16-60 years old)
N Engl J MedVolume 377(11):1011-1021
September 14, 2017
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Randomisation
1:1:1 randomisation with sub-groups if contra-indications to one modality
664 patients recruited 2008-2016
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Kaplan-Meier Estimates
NNT: 20 to prevent 1 recurrent stroke over 5 years
Anti-coagulation vs Anti-platelets – 3 vs 7 events; p=0.44 (0.11-1.48 CI)
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Adverse Events
10 of 11 device related AF cases were within 30 days of procedure
and did not recur in a median follow-up of 4.4 years
Procedural complication rate = 14 (5.9%)
Follow-up echocardiography (mean 10.8 months) – 93% had <10 microbubbles
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Original Article
Patent Foramen Ovale Closure or Antiplatelet Therapy for Cryptogenic Stroke
REDUCE Clinical Study Investigators
Comparing PFO closure (combined with antiplatelet therapy) vs antiplatelet therapy on the risk of recurrent stroke and new brain infarction (24 months): 664 patients
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Kaplan-Meier Estimates
PFO Closure: 6 (1.4%) vs Antiplatelets 12 (5.4%)
NNT: 28 to prevent 1 recurrent stroke in 24 months
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Adverse Events
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Limitations
• Total number events were small
• Potential for bias for differential drop out
rates
• Generalisability due to concurrent closure
outside trial
• Absence of prolonged cardiac monitoring
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Implications
• Not all patients with PFO require closure
• Stroke as a result of PFO is uncommon
• Thorough analysis of risk factors is required
prior to embarking on closure
• Potential benefit of closure is determined by
patient characteristics and anatomical
abnormalities of PFO
• Closure can be conducted with a high degree of
safety and efficacy in carefully select patients to
reduce stroke long term