FAST-Mag Audience Inquiry Double blind, placebo controlled trial - - PowerPoint PPT Presentation

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FAST-Mag Audience Inquiry Double blind, placebo controlled trial - - PowerPoint PPT Presentation

Mar 07, 2023 419 likes •506 views

ISC 2014 Meeting Disclosures Endovascular and Neuroprotection IA t-PA is not labeled for clinical use NIH U10NS086494 - PI, NorCal-RCC U10 NS058931 NETT DSMB HCRI, NIH, Stryker and Covidien Wade S. Smith, MD, PhD

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ISC 2014 Meeting Endovascular and Neuroprotection

Wade S. Smith, MD, PhD UCSF Department of Neurology

Disclosures

  • IA t-PA is not labeled for clinical use
  • NIH
  • U10NS086494 - PI, NorCal-RCC
  • U10 NS058931 – NETT
  • DSMB HCRI, NIH, Stryker and Covidien

FAST-Mag

  • Double blind, placebo controlled trial of IV

Mg given prehospital

  • 1700 patients
  • 8 years
  • J. Saver PI
  • 95 Coordinators and research assistants

Audience Inquiry

  • 1. None of the clot retriever devices have

been shown to be effective. When do the catheter jockeys take no for an answer?

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SLIDE 2

2

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SLIDE 3

3

Acute Stroke Therapy

  • SYNTHESIS- Expansion Study
  • IMS-III Study
  • MR RESCUE

February epub 2013

SYNTHESIS Expansion

  • Italian Medicines Agency sponsored, randomized,

prospective trial of endovascular t-PA vs. IV t-PA

Ciccone et al, NEJM, epub Feb 2013

R 1: 1

Stroke

CT No hemorrhage

IV t-PA < 4.5 hr IA t-PA ASAP

Outcome: 90-Day mRS

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SLIDE 4

4

SYNTHESIS Expansion

  • Italian Medicines Agency sponsored, randomized,

prospective trial of endovascular t-PA vs. IV t-PA

Ciccone et al, NEJM, epub Feb 2013

R 1: 1

Stroke

IV t-PA < 4.5 hr IA t-PA ASAP

Outcome: 90-Day mRS 181 181 362

CT No hemorrhage

2.75 hr 3.75 hr

Ciccone et al, NEJM, epub Feb 2013

MR RESCUE

  • NIH sponsored, randomized, prospective trial of

endovascular vs. medical therapy selected by penumbral pattern

R

1:1

Stroke

CTA/MRA +LVO IV t-PA allowed

Medical Therapy

Outcome: 90-Day mRS

Kidwell et al, NEJM, epub Feb 2013

Penumbra Present Penumbra Absent MRP/CTP Analysis R

1:1

Endovascular Medical Therapy Endovascular

< 6 hours

MR RESCUE

  • NIH sponsored, randomized, prospective trial of

endovascular vs. medical therapy selected by penumbral pattern

R

1:1

Stroke

CTA/MRA +LVO IV t-PA allowed

Outcome: 90-Day mRS

Kidwell et al, NEJM, epub Feb 2013

Penumbra Present Penumbra Absent MRP/CTP Analysis R

1:1

< 6 hours

34 34 20 30

Medical Therapy Endovascular Medical Therapy Endovascular

137

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SLIDE 5

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Kidwell et al, NEJM, epub Feb 2013 Kidwell et al, NEJM, epub Feb 2013

MR RESCUE IMS-III

  • NIH sponsored, randomized, prospective trial of

IV t-PA vs. IV t-PA + endovascular

R

2:1

Stroke

CT No hemorrhage

IV t-PA

Finish t-PA IA t-PA EKOS t-PA MERCI Penumbra Solitaire

Outcome: 90-Day mRS

Broderick et al, NEJM, epub Feb 2013

IMS-III

  • NIH sponsored, randomized, prospective trial of

IV t-PA vs. IV t-PA + endovascular

R

2:1

Stroke

CT No hemorrhage

IV t-PA

Finish t-PA IA t-PA EKOS t-PA MERCI Penumbra Solitaire

Outcome: 90-Day mRS

Broderick et al, NEJM, epub Feb 2013

656 222 434 58 study centers 6 years

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SLIDE 6

6

Broderick et al, NEJM, epub Feb 2013

Time to Reperfusion and Good Clinical Outcome

Observed Vs Predicted.

ICAT, M1, and M2 Cases with Reperfusion with 95% confidence bands (p=0.0045) Observed values shown as horizontal bars for every ~20 subjects

Time to Reperfusion and Good Clinical Outcome Unadjusted Analysis

Risk Ratio 95% CI p-value Time to Reperfusion (every 30 minutes) 0.86 0.78-0.95 p=0.0045 Every 30 minute delay in reperfusion is associated with a 14% relative reduction in probability of good clinical outcome (mRS 0-2).

IV t-PA vs. IV t-PA + Endovascular

Endovascular vs. Medical Therapy

Endovascular vs. Medical Therapy (image selection)

0 hr 24 6.0 4.5

IV T-PA eligible IV T-PA ineligible All Studies: CTA/MRA/DSA Carotid T/L and M1 +/- M2 occlusions All Studies: CTA/MRA/DSA Carotid T/L and M1 +/- M2 occlusions

Future Endovascular Trials

SWIFT-PRIME DAWN

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Audience Inquiry

  • 1. None of the clot retriever devices have

been shown to be effective. When do the catheter jockeys take no for an answer?

  • 2. Is tPA at 4.5 hrs standard of care even if

not approved by FDA?

Audience Inquiry

  • 1. None of the clot retriever devices have

been shown to be effective. When do the catheter jockeys take no for an answer?

  • 2. Is tPA at 4.5 hrs standard of care even if

not approved by FDA?

– It is off-label use; most stroke centers offer it – We suggest informed consent – >80 year age restriction should not be

Audience Inquiry

  • 1. OSA screening in stroke patients

– Unclear is it is an independent risk factor – Associated with stroke – Reasonable to screen for OSA then refer if found