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CASES (Canadian Alteplase for Stroke Effectiveness Study). The CASES Investigators. Conditions of use.

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CASES (Canadian Alteplase for Stroke Effectiveness Study)

The CASES Investigators

CASES - Original article available at www.cmaj.ca


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Conditions of use

  • Please use these slides freely to describe the CASES study. For background information and details of the study, refer to the full report (published in the May 10, 2005, issue of CMAJ, available at www.cmaj.ca).

CASES - Original article available at www.cmaj.ca


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Financial disclosure

  • CASES was funded by:

    • Hoffmann-La Roche Canada Ltd.

    • Canadian Stroke Consortium

    • Canadian Stroke Network

  • Personnel were funded by:

    • Heart & Stroke Foundation of Canada

    • Canadian Institutes of Health Research

CASES - Original article available at www.cmaj.ca


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Centres

  • 60 centres actively treating stroke– 27 (45%) teaching hospitals– 33 (55%) community hospitals

  • The majority of treating physicians were neurologists

CASES - Original article available at www.cmaj.ca


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Patients

• CASES was a postmarketing registry of patients with acute ischemic stroke receiving treatment with the tissue plasminogen activator (tPA) alteplase

• A total of 1135 patients were enrolled– 25 patients were lost to all follow-up after 24 hours

CASES - Original article available at www.cmaj.ca


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Baseline characteristics (n = 1135)

Sex 55% male 45% female

Handedness 95% right 4% left

Symptom side 55% right 44% left 1% bilateral

Mean age, yr 70 (SD 13, range 20–97)

Ethnicity 91.3% white 4.5% Asian 4.8% other

NIHSS score, median 14 (range 2–40)

Note: NIHSS = National Institutes of Health Stroke Scale

CASES - Original article available at www.cmaj.ca


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Baseline volume

  • High volume (> 1 patient/month):

    • 10 centres (61% of patients)

  • Low volume (< 1 patient/month):

    • 50 centres (39% of patients)

CASES - Original article available at www.cmaj.ca


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Baseline stroke risk factors

CASES NINDS

Hypertension 50% 67%*

Ischemic heart disease 24%

Prior TIA or stroke 23% 26.5%

Atrial fibrillation 22% 18%

Antiplatelet therapy 20% 33%

High cholesterol 19%

Diabetes mellitus 16% 20%*

Current smoker 15% 31%*

History of cancer 7%

Congestive heart failure 7% 17.5%*

Valvular heart disease 4%

Subtherapeutic INR 3%

Dementia 2% *p < 0.05

CASES - Original article available at www.cmaj.ca


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90-day outcomes

CASES - Original article available at www.cmaj.ca


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Adverse events

  • Symptomatic intracranial hemorrhage (ICH):

    • 52 patients (4.6% [95% CI 3.4%–6.0%])

    • 90-day mortality: 79%

  • Anaphylactoid/angioedema reaction

    • 15 patients (1.3% [95% CI 0.7%–2.2%])

CASES - Original article available at www.cmaj.ca


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Time to treatment

215

Frequency

0

0

60

120

180

240

300

360

Onset-to-treatment time, min

CASES - Original article available at www.cmaj.ca


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Median interval times

Onset to ED 56 min

ED to CT scan 36 min

CT scan to treatment 44 min

Door to treatment 85 min

Onset to treatment 155 min

Note: ED = emergency department

CASES - Original article available at www.cmaj.ca


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Protocol violations and symptomatic ICH rate

Protocol violations: – onset-to-treatment time > 180 minutes, platelet count < 100 ´ 109/L, INR > 1.4, tPA dose > 90 mg

Symptomatic ICH rate:– 7.8% (violation) v. 3.9% (no violation) RR 2.0 (95% CI 1.1–3.8)

CASES - Original article available at www.cmaj.ca


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ASPECTS predicts outcome

Probability of excellent outcome

Baseline ASPECTS score

CASES - Original article available at www.cmaj.ca


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Predictng symptomatic ICH

Variable Odds ratio (95% CI)

­ baseline glucose 1.6 (1.2–2.3) per 5-mmol/Llevel increase in level

­ onset-to-treatment 1.2 (1.0–1.5) per 30-mintime increase in time

CASES - Original article available at www.cmaj.ca


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Conclusions — goals met!

• Alteplase is safe and effective for the “real-world” clinical treatment of acute ischemic stroke.

CASES - Original article available at www.cmaj.ca