10 may 2005 cases - original article available at cases (canadian alteplase for stroke...

10 May 2005

CASES - Original article available at www.cmaj.ca

CASES (Canadian Alteplase for Stroke Effectiveness Study)

The CASES Investigators

10 May 2005


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).

10 May 2005


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

10 May 2005


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

• The majority of treating physicians were neurologists

Centres

10 May 2005


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

10 May 2005


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

10 May 2005


Baseline volume

• High volume (> 1 patient/month):

– 10 centres (61% of patients)

• Low volume (< 1 patient/month):

– 50 centres (39% of patients)

10 May 2005


Baseline stroke risk factorsCASES 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

10 May 2005


90-day outcomes

36.8

31.8

25.3

24.6

24.5

24

8.8

16.3

21.4

11.9

9.6

22.3

22.3

22.3

22.3

16.6

10.449.0

0% 20% 40% 60% 80% 100%

adj mRS

mRS

NIHSS

Residence

Excellent

Moderate

Poor

Death

Not recorded

10 May 2005


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%])

10 May 2005


Fre

qu

enc

y

Onset-to-treatment time, min0 60 120 180 240 300 360

0

215

Time to treatment

10 May 2005


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

10 May 2005


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)

10 May 2005


ASPECTS predicts outcome0

.1.2

.3.4

.595

% C

I/Fitt

ed v

alue

s

0 2 4 6 8 10Pre-treatment ASPECTS

Pro

bab

ilit

y o

f ex

cell

ent

ou

tco

me

Baseline ASPECTS score

10 May 2005


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

10 May 2005


Conclusions — goals met!

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

10 may 2005 cases - original article available at cases (canadian alteplase for stroke...

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