Evidence Based Stroke Update Ajay Bhalla Guy s and St Thomas Hospitals UK Stroke Forum
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1 Evidence Based Stroke Update 2017 Ajay Bhalla Guy s and St Thomas Hospitals UK Stroke Forum
2 Future is hard to predict..
3 Future is hard to predict..
4 Future is hard to predict..
5 Future is hard to predict..
6 Future is hard to predict..
7 Lecture Outline Early Rehabilitation Secondary Prevention Intra-arterial interventions Organised stroke care
8 Optimal Head Position
9 What does the Guideline say?
10 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 Med Volume 376(25): June 22, 2017
11 11
12 Characteristics of the 11,093 Patients with Acute Stroke at Baseline. Anderson CS et al. N Engl J Med 2017;376:
13 Intervention Effects in the Lying-Flat Group and the Sitting-Up Group at 90 Days, According to Modified Rankin Scale Score. Odds ratio: 1.01; 95 CI: 0.92 to 1.10; P=0.84 Anderson CS et al. N Engl J Med 2017;376:
14 Safety 14
15 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.
16 Early Rehabilitation Secondary Prevention Intra-arterial interventions Organised stroke care
17 PFO and Stroke 20-30% of ischaemic stroke: cryptogenic Mechanism: Paradoxical Embolism 3 fold increase in recurrent stroke
18 PFO and Stroke
19 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
20 What does the Guidelines Say?
21 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 N therapy Engl J Med or PFO closur Volume 377(11): September 14, 2017
22 Recurent ischaemic stroke: PFO 18 (3.6%) vs Medical 28 (5.8%) NNT: 43 to prevent 1 recurrent stroke over 5 years
23
24 Rate of Recurrent Ischemic Stroke According to Subgroup. Saver JL et al. N Engl J Med 2017;377:
25 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:
26 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 anticoagulation In patients with atrial septal aneurysm or large interatrial shunt (16-60 years old) N Engl J Med Volume 377(11): September 14, 2017
27 Randomisation 1:1:1 randomisation with sub-groups if contra-indications to one modality 664 patients recruited
28 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 ( CI)
29 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
30 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
31 Kaplan-Meier Estimates PFO Closure: 6 (1.4%) vs Antiplatelets 12 (5.4%) NNT: 28 to prevent 1 recurrent stroke in 24 months
32
33 Adverse Events
34 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
35 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
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