Thrombolytic therapy in Stroke Trials

Question 1

Why debate on thrombolysis in stroke

Answer 1

• validity of key study results
• credibility of research
• accurate representation of data & selective reporting results
• role of industry in research
• level of evidence needed to influence practice change
• allocation of resources b/w acute stroke care & stroke prevention

Question 2

Stroke care resource allocation to prevention

Answer 2

• BP control
• carotid endarterectomy
• warfarin for high risk AF
• Aspirin

Question 3

Negative trials- used streptokinase

Stopped early because mortality

Answer 3

ASK
MAST-I
MAST- E

Question 4

NINDS: national institute of neurological Disorders & Stroke Study

Answer 4

• sponsored by tPA manufacturers
• Multi centre RCT
• 291 + 333 px
• tPA vs Placebo
• Poorly matched groups: severe stroke in placebo group
• Showed benefit in < 3 hrs BUT 1/2 treated in 90 min

Question 5

NINDS: results

Answer 5

• no neuro improvement at 24 hrs
• favourable improvement at 3 months
• ICH 6.4% with tPA & 0.6 % placebo
• Mortality: 17% tPA vs 21% placebo

Question 6

ECASS: European Cooperative Acute Stroke Study

Answer 6

• multi center RCT
• manufacturer sponsored
• 620 px
• well matched treatment arms
• 6 hr limit to treatment

Question 7

ECASS Resutls

Answer 7

• significant increase ICH

- non significant mortality & improvement