the dawn of a new stroke care revolution implications for...
TRANSCRIPT
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The DAWN of a New Stroke Care Revolution
Implications for EMS
Peter Panagos, MD, FACEP, FAHAProfessor of Emergency Medicine and Neurology
Washington University School of Medicine
You really need to know this sh##!!
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Disclosures
• Advisory Committee, American Stroke Association (Volunteer)• Medical Legal Work (Stroke, mostly Defense)• Speaker’s Bureau‐Genentech• Employer‐Washington University • Stroke is a real disease and all patients should at least be considered for treatment options, if eligible
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Objectives
• Discuss the new stroke trials that extend stroke treatment window out to 24 hours after symptom onset
• Brief description of Joint Commission Stroke Center Levels and Capabilities
• Understand implications for EMS providers and Systems
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St Louis Stroke Care Prior to 2017• 63 y/o male with “stroke symptoms”• Found in back yard• LKW maybe 8 hours ago?• CPSS ++ (face/arm/speech)• FSBS 106, BP 156/87• Brought to a Primary Stroke Cen• Stroke Team activated• Outside any treatment window• No intervention offered• Discharged to a Rehabilitation Hospital• Never Able to Return to Work
ED CT Scan
MRI at 36 Hours
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Pre‐hospital Stroke is Undifferentiated
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Evolution of Stroke Treatment in US
1995 – NINDS (0‐3)
2008 – ECASS III (3‐4.5)
2016 – HERMES (0‐7.3)
2018 – DAWN (6‐24)‐‐ DEFUSE 3 (6‐16)
Time is Brain
13
8
2
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TWO TRIALS, NEW OPPORTUNIES
In Place Very Near, In a Time Not So Long Ago, This Was the Gospel…And There Was Light
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The DAWN trial
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Design
• Prospective Open‐label, Blind‐outcome assessment (PROBE) • Enrolled 1:1 ratio thrombectomy versus “best medical care” • Stratified by mismatch criteria, time from LKN to randomization (6 to 12 hrs vs >12 to 24 hrs), and the occlusion site
• Utilized RAPID software as part of selection criteria• Used only Trevo device for thrombectomy
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Inclusion Criteria• Age ≥ 18 years• NIHSS ≥ 10 and mRS ≤ 2• Last known normal and randomized within 6‐24 hours• Proximal vessel occlusion on CTA/MRA
– Cervical or ICA / Proximal MCA
• Imaging Criteria (RAPID): Groups A, B and C– Group A: Age ≥ 80, NIHSS ≥ 10, Infarct volume < 21 ml– Group B: Age < 80, NIHSS ≥ 10, Infarct volume < 31 ml– Group C: Age < 80, NIHSS ≥ 20, Infarct volume 31 to 50 ml
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RAPID software infarct prediction
RAPID ischemic core (dead brain) and hypoperfusion volumes (tissue at risk) predicted infarct size (final stroke)
• Baseline core predicts infarct volume in reperfusers (CBF<30%)
• Baseline hypo‐perfusion predicts infarct in non‐reperfusers (Tmax > 6 seconds)
Albers GW, et al. Annals of Neurology, 2015 (Slide Courtesy of Akash Kansagra, MD)
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Results
• 26 centers in US, Canada, Europe and Australia• Interim analysis and trial halted because pre‐specified efficacy boundary had been exceeded
• 206 patients enrolled from September 2014‐February 2017
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Summary of Results
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Modified Rankin Scale
•No symptoms, no disability0•Minor symptoms, not effecting activities of daily living –Could return to work in most cases1•Symptoms effecting activities of daily living, independent living
2•Requires assistance3•Continued nursing care4•24 hour skilled nursing 5•Deceased6
Favorable Outcome
“Good” Outcome
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Summary of Results
For the 1st Time Ever in the History of
Stroke We Can Rapidly Pick and Choose the Right Patient for the Right Therapy Out out 24 Hours After Onset
of Symptoms!!
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The DEFUSE 3 Trial
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Design• Prospective Open‐label, Blind‐outcome assessment (PROBE) • Enrolled 1:1 ratio thrombectomy versus “best medical care” • Stratified by age, core infarct volume, time from symptom onset to enrollment, baseline NIHSS, and trial site
• Utilized RAPID software in selection criteria• Any FDA approved thrombectomy device was allowed
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Inclusion Criteria
• Age 18‐90 years• NIHSS ≥ 6 and mRS ≤ 2• Last known normal 6‐16 hours• Proximal vessel occlusion on CTA/MRA
– Cervical or ICA / Proximal MCA• Imaging Criteria (RAPID):
– Initial infarct volume < 70 ml– Mismatch ratio ≥ 1.8– Volume Tmax > 6 seconds ≥ 15ml
Key Differences from DAWN:
1. Overall more permissive2. Except for Treatment window 16 hours
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Results
• 38 US centers, part of StrokeNet• Put on hold when DAWN results released• Interim analysis and trial halted because pre‐specified efficacy boundary had been exceeded
• 182 patients enrolled from May 2016‐May 2017
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Results
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ResultsPrimary Outcome: more favorable distribution of disability scores on mRS at 90 days
Unadjusted odds ratio: 2.77 (95% CI 1.63‐4.70; p<0.0001) Adjusted odds ratio: 3.36 (95% CI 1.96‐5.77; p<0.0001)
mRS 0‐2 44%
mRS 0‐2 16%
Secondary Outcome Safety Outcome
90 d Mortality
NNT = 1/(.44‐.16) = 3.57 ≅ 4 for good functional outcome
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Results
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Conclusion
• Second trial to show benefit of thrombectomy beyond 6 hour window in carefully selected subjects
• NNT ≅ 4– Low rate of favorable outcomes in medical group– Low rate of tPA usage in either group
• Confirmed DAWN results, expanded group of eligible patients• Now part of the AHA treatment guidelines (Jan 2018)
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LVO = Large Vessel Occlusion
Middle Cerebral Artery (MCA)Anterior Cerebral Artery (ACA)
http://emedicine.medscape.com/article/1916852‐overview#a3Goyal M et al. N Engl J Med 2015;372:1019‐1030
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Thrombectomy of LVO
Castano C et al. Stroke 2010; 41:1836‐1840.http://img.medscape.com/news/2014/ht_141217_stent_retriever_800x600.jpg
M1
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Early is Still Better, Right??
Why Larger Benefits with Late Treatment?
• Many patients with LVO have slow growth core up to 12 hours++
• Favorable collateral circulation keeps ischemic core small but eventually fails
• Outcomes in control groups of these trials influenced by whether tPA given or not
Stroke. 2018;49:768‐771
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2018 AHA/ASA Stroke Guidelines
Stroke. 2018:49:e1‐e65
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So What Should We Do?When Should We Do Something?
Should We Wait for Additional Science?Should Hospital Capability Matter for EMS Triage?
Is EMS Bypass Safe?Do Stroke Outcomes Matter?
How Do We Know Who Provides the Best Care?
What is the Role of EMS in the Stroke System of Care?
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SCAAD EMS Protocol 35 (2018)
Courtesy of Dr. Leo Hsu, MD, MBA, Mdiv, FACEP
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Draft Proposal of East Central Regional EMS
Triage Plan
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BJH Thrombectomy Protocol
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BJC Thrombectomy Protocol
Still should receive IV tPA if < 4.5 hours and eligible
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Circulation. 2017;136:2311‐2321
Time from Symptom Onset Matters to
Treatment Still Matters
Transfer Times Matter
Stroke. 2018;49:952‐957
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Next Steps?
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Levels of Stroke Care in MO
The Joint Commission/DNV GL
• Acute Stroke Ready Hospitals (0)– Drip N’ Ship
• Primary Stroke Hospitals (17)– IVT and some with EVT
• Thrombectomy Capable Centers (0)– IVT + EVT (same standards as CSC)
• Comprehensive Stroke Centers (3)– IVT + EVT + Advanced Care
Missouri TCD Stroke Levels
• Level IV (3)– Bypass
• Level III (17)– IVT Capable but Drip N’ Ship
• Level II (24)– PSC capabilities
• Level I (12)– CSC Lite
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So, As Region What We Ultimately Decide Will Impact Stroke Patient Outcomes
Map Provided by:St. Louis County's Emergency Operations Center
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St Louis Stroke Care 2018 and Beyond• 63 y/o male with “stroke symptoms”• Found in back yard• LKW maybe 8 hours ago?• CPSS ++ (face/arm/speech)• FSBS 106, BP 156/87• EMS bypassed to a Large Stroke Center• Stroke Team activated (NIHSS 13)• Outside any treatment window• RAPID CT Performed• Mechanical Thrombectomy performed• Discharged to Home with HHS (NIHSS 1)• Returns to Work in a Week
ED CT Scan
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Questions?