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C2 Modules CLINICAL > Treatment of Ischaemic and haemorrhagic stroke > Flashcards

Treatment of Ischaemic and haemorrhagic stroke Flashcards

1
Q

What are used for Intravenous thrombolysis: standard IV thrombolysis: evidence?

A
  1. NINDS trial 1995
  2. Cochrane review
  3. ECASS-3
  4. IST-3
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2
Q

What is NINDS-2 trial?

A

randomized, double-blind trial of intravenous recombinant tissue plasminogen activator (t-PA) for ischemic stroke after recent pilot studies suggested that t-PA was beneficial when treatment was begun within three hours of the onset of stroke

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3
Q

What did part 1 of NINDS trial assess?

A

Changes in neurologic deficit 24 hours after the onset of stroke as a measure of the activity of t-PA

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4
Q

What did part 2, pivotal study of NINDS trial use?

A

Four outcome measures representing different aspects of recovery from stroke to assess whether treatment with tPA resulted in sustained clinical benefit at 3 months

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5
Q

What was part 1 of NINDS trial designed to test?

A

Whether t-PA had clinical activity
Specifically, whether a greater proportion of patients treated with t-PA as compared with those given placebo had early improvement

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6
Q

How was early improvement defined as by NIHSS?

A

Complete resolution of neurologic deficit or an improvement from base line in score by 4 or more points 24 hour after the onset of stroke

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7
Q

How was each group in part 1 of NINDS trials assessed according to?

A 
Time from onset of stroke to the beginning of the treatment 
1. 0 to 90 minutes
2. 91 to 180 minutes
3. 0 to 180 minutes
after onset of stroke
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8
Q

What was the primary hypothesis for part 2 of NINDS trial?

A

There would be a consistent and persuasive difference between t-PA and placebo groups in terms of proportion of patients who recovered with minimal or no deficit three months after treatment

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9
Q

When did the study find a benefit of intravenous t-PA therapy for patients with ischemic stroke?

A

When treatment was initiated within 3 hours of the onset of symptoms

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10
Q

What werepatients that were treated with t-PA likely have?

A

at least 30% more likely to have minimal or no disability at three months as measured by the outcome scales

This benefit was not associated with any increase in mortality

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11
Q

an improvement in clinical outcome at three months was found in patients

A

treated with intravenous t-PA within three hours of the onset of acute ischemic stroke.

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12
Q

What are Grotto bars?

A

Distribution of modified Rankin scores by OTT interval

  1. 0 = no symptoms at all
  2. 1 = no significant disability, despite symptoms, able to perform all usual duties and activities.
  3. 2 = slight disability; unable to perform all previous activities but able to look after own affairs without assistance
  4. 3 = moderate disability, require some help but able to walk without assistance
  5. 4= moderately severe disability, unable to walk without assitance and ubale to attend to own bodily needs
  6. 5.severe disability = bedridden, incontinent, constant nursing care and attention
  7. 6= dead
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13
Q

What is the difference between placebo and tPA group?

A

About 13%

13% absolute risk reduction

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14
Q

What is most of the interest in stroke trial between?

A

0-2 on the scale e.g. heavy stroke

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15
Q

What happems if tPA is completely neutral?

A

the OTTs ( a statistical measure) ratio will be 1

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16
Q

What happens if anything below OTT line?

A

The treatment is harmful

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17
Q

What happens if anything is above OTT line?

A

The treatment is beneficial

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18
Q

What does the Cochrane review bring together?

A

Information on controlled studies (mostly randomised controlled trials) in a standard format

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19
Q

Cochrane Review 2003

A
  1. 18 trials (16 iv, 2ia) - 5727 patients
  2. 4 agents: rtPA (50%), SK, UK, rpUK
  3. Fewer patients dead or dependent
  4. More deaths in the first 7-10 days
  5. rtPA possibly less hazard and more benefit
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20
Q

Where does many of the important treatment that is given in medicine go through?

A

Very standardised and very dull process of evaluation where they take all of the data

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21
Q

What did Cochrane Review 2003 analyse?

A

Data with different agents

They were looking at the principles of giving thrombolytic agents

22
Q

What did Cochrane Review 2003 demonstrate?

A

Benefits in the meta-analysis

Demonstrated that most benefit will be within the first 3 hours and the patients were treated with tPA

23
Q

What is ECASS-I?

A

First large randomized, multi-centre, double-blind, placebo-controlled trial of thrombolysis for stroke

24
Q

What was ECASS-3: 3-4 ½ hours designed to evaluate?

A

Efficacy of IV tPA within 6 hours of symptom onset when compared to placebo in patients presenting with acute hemispheric ischemic stroke with moderate to severe neurologic deficit

25
Q

ECASS-3: 3-4 ½ hours

A

European trial with different countries and they repeated the NINDS trial with the same inclusion and exclusion criteria and same kind of population

26
Q

ECASS-3: 3-4 ½ hours

A

They looked at time window of 3-4 ½ hours instead of 0-3 hours

27
Q

What is the absolute reduction risk for ECASS-3: 3-4 ½ hours?

A

7%

the benefit was clearly very statistically significant

28
Q

What did the IST-3 sought to determine?

A

Whether a wide range of patients might benefit up to 6 hours from stroke onset

29
Q

What is IST-3?

A

Biggest trial of intravenous thrombolysis

Looked at group of patients who were not eligible for standard thrombolysis - who are younger than 80 years of age and are treated within 4.5hours

30
Q

IST-3

A

A study of patients who could not be thrombolysed ‘routinely’ (n=3035)

  • Older patients (>80)
  • Presenting later ( after 3hr, then after 4.5hr)
31
Q

What was the results for IST-3?

A
  1. Neutral for ‘favourable outcome’
  2. Sub-group analyses:
    - Not much benefit beyond 4.5 hrs
    - Support for tPA for older patients <3hr
32
Q

What takes about 4 and 1/2 hours to develop?

A

FLAIR signal

33
Q

What are the wake-up results?

A
  • Those not receiving the acute treatment – 42%
  • Favourable outcome: 53%
  • It is not about crossing people over that one threshold between disabled and un-disabled, the other patients are benefitting as well
34
Q

Why are we using a clock to determine who should be treated and who should not be treated?

A
  • Some of the patients who get an occlusion of a large vessel in intracerebral vessels are going to be able to support the threatened area with good collaterals
  • The progression to infarction or permanent damage is going to be very slow
  • Other people will have no collaterals at all, and they are going to have permanent infarction of the whole area that is being threatened by the occluded vessel within half hour
35
Q

EXTEND Trial (May 2019)

A
  1. 4.5 to 9hr after stroke onset or woke within 9hr of midpoint of sleep
  2. Perfusion-mismatch (CT or MR perfusion, automated processing ratio > 1.2 penumbra, >10ml, core <70ml)
  3. 225 of planned 310 patients enrolled
  4. stopped early (loss of equipoise)
36
Q

What was the EXTEND Trial results?

A
  • Their primary outcome was 0-1
  • Placebo group is 30% and the treated group is 45%
  • The benefit is small
  • 6% absolute risk reduction
  • If you treat patients later, they will do less well
37
Q

IV tPA now

A
  1. Within 4.5 hrs
    - Rapid plain CT (+ CTA for LVO)
    - Then get on with it
  2. Unknown time of onset
    - MRI to age infarct
    - CT/MR perfusion to look for mis-match
  3. Known onset beyond 4.5-9hrs
    - Small sub-group who may still benefit
38
Q

What are two more negative trials (2013)?

A
  1. Synthesis-Expansion
    - 4.5 hr of stroke onset
    - Endovascular vs iv tPA
  2. MR-RESCUE
    - 8 hr of stroke onset
    - CT perfusion or MR perfusion
    - No penumbra: completely neutral
    - Penumbra: endo patients did a bit worse
39
Q

What are the new devices?

A
  1. Penumbra

2. Solitaire

40
Q

MR CLEAN 2015

A

Randomly assigned eligible patients to either intraarterial treatment plus usual care or usual care alone

The primary outcome was the modified Rankin scale score at 90 days;

41
Q

What was the conclusion of MR CLEAM

A

In patients with acute ischemic stroke caused by a proximal intracranial occlusion of the anterior circulation, intraarterial treatment administered within 6 hours after stroke onset was effective and safe.

modified rankin 0-2

42
Q

What was odd about MR CLEAN

A

A long time window between time tPA was given routinely and time that were randomised to trial

43
Q

What is the ESCAPE protocol?

A
  1. Good pre-morbid state
  2. Enrollment up to 12hr post-stroke
  3. CT and CTA
  4. Small core infarct (ASPECTS 6-10)
  5. M1 or M2 occlusion
  6. Moderate-to-good collaterals on CTA
44
Q

EXTEND-IA 2015

A
  1. tPA candidates only (4.hr window)
  2. M1/M2 occlusions
  3. Endovascular within 6 hr
  4. CT perfusion for ‘salvageable tissue’
    - small core (<70ml)
    - Penumbra (mismatch > 10ml & >20% of core)
45
Q

SWIFT-PRIME 2015

A
  1. small amount of damage on CT

2. Small core

46
Q

What is REVASCAT?

A

Population drawn from broader endovascular registry

47
Q

DAWN clinical criteria

A
  1. Small trial
  2. Interested in patients that present beyond 6 hours
    [ Within 6 hours thrombectomy is an established treatment]
  3. Select patients using imaging criteria rather than time window
  4. 9% given tPA
48
Q

DAWN criteria

A

Assess penumbra by looking at the patients
How big is the stroke
How much brain is threatened by the infarction

49
Q

DEFUSE-3 clinical trial

A

conducted a multicenter, randomized, open-label trial, with blinded outcome assessment, of thrombectomy in patients 6 to 16 hours after they were last known to be well and who had remaining ischemic brain tissue that was not yet infarcted.

Not given iv tPA > 4.5 hr from onset

50
Q

DEFUSE-3 radiological criteria

A
  1. Terminal ICA or M1 occlusion (CTA or MRA)
  2. Core <70 ml
  3. Penumbra > 15ml
  4. Total ischaemic volume/core vol > 1.8

C2 Modules CLINICAL (26 decks)

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