Control Group: (n = 10396, 10396 analysed): streptokinase , 1.5 million units over a period of 30 to 60 minutes
Experimental Group: (n = 10372, 10372 analysed): tissue plasminogen activator , 100 mg over a three hour period
10, 361 patients were also randomised to receive subcutaneous heparin (12, 500 units twice daily), whereas 10, 407 did not.
100% followed for ?weeks
Outcome notes:

The evidence

Myocardial infarction: tPA causes more strokes than streptokinase.

Clinical bottom line (level 1b)

  1. Patients with acute myocardial infarction who are given tissue plasminogen activator, are more likely to have a stroke than those given streptokinase (NNH = 258 at unknown) .
  2. Patients who are given tissue plasminogen activator have no clear difference in haemorrhagic or ischaemic stroke, than those given streptokinase.
  3. Patients given heparin had no clear difference in stroke than those not given heparin.
Maggioni et al: New England Journal of Medicine 1992; 327 (1): 1-6
Expires March 2003

The study

?blinded ?concealed randomised trial with intention-to-treat
Setting: multicentre, Italy and Belgium

20768 patients (aged ?, ?% male) chest pain with ST-segment elevation of 1mm or more in any lead of the ECG, 2 mm or more in any precordial lead, or both, and admitted within six hours of symptom onset

Excluded if
  • contraindication to thrombolytic or antithrombotic treatment


  • Control Group: (n = 10396, 10396 analysed): streptokinase , 1.5 million units over a period of 30 to 60 minutes
    Experimental Group: (n = 10372, 10372 analysed): tissue plasminogen activator , 100 mg over a three hour period
    10, 361 patietns were also randomised to receive subcutaneous heparin (12, 500 units twice daily), whereas 10, 407 did not.
    100% followed for ?
    Outcome notes:
    • stroke : sudden focal neurologic deficit lasting >24 hours

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)
    ARR
    (95% CI)
    NNT
    (95% CI)
    stroke unknown 98
    (0.94%)
    138
    (1.33%)
    -41.0%
    (-83.0% to -9.00%)
    -0.39%
    (-0.68% to -0.10%)
    -258
    (-1005 to -148)
    haemorrhagic stroke unknown 30
    (0.29%)
    44
    (0.42%)
    -47.0%
    (-134% to 8.00%)
    -0.14%
    (-0.30% to 0.03%)
    -737
    (NNT = 336 to infinity;
    NNH = 3780 to infinity)
    ischaemic stroke unknown 46
    (0.44%)
    54
    (0.52%)
    -18.0%
    (-74.0% to 21.0%)
    -0.08%
    (-0.27% to 0.11%)
    -1280
    (NNT = 375 to infinity;
    NNH = 908 to infinity)
    stroke with heparin unknown 119
    (1.14%)
    117
    (1.13%)
    1.00%
    (-27.0% to 23.0%)
    0.01%
    (-0.27% to 0.30%)
    7029
    (NNT = 365 to infinity;
    NNH = 331 to infinity)

    Citation

    1. Maggioni AP, Franzosi MG, Santoro E, et al: The risk of stroke in patients with acute myocardial infarction after thrombolytic and antithrombotic treatment. New England Journal of Medicine 1992; 327 (1): 1-6
    Contributor: Clare Wotton, February 2000
    Reviewer:

    Clinical Question.
    Patient myocardial infarction
    Intervention or Exposure streptokinase
    Comparison tissue plasminogen activator
    Outcome stroke
Outcome Time to outcome CEREERRRR
(95% CI)
ARR
(95% CI)
NNT
(95% CI)
stroke unknown 98
(0.94%)
138
(1.33%)
-41.0%
(-83.0% to -9.00%)
-0.39%
(-0.68% to -0.10%)
-258
(-1005 to -148)
haemorrhagic stroke unknown 30
(0.29%)
44
(0.42%)
-47.0%
(-134% to 8.00%)
-0.14%
(-0.30% to 0.03%)
-737
(NNT = 336 to infinity;
NNH = 3780 to infinity)
ischaemic stroke unknown 46
(0.44%)
54
(0.52%)
-18.0%
(-74.0% to 21.0%)
-0.08%
(-0.27% to 0.11%)
-1280
(NNT = 375 to infinity;
NNH = 908 to infinity)
stroke with heparin unknown 119
(1.14%)
117
(1.13%)
1.00%
(-27.0% to 23.0%)
0.01%
(-0.27% to 0.30%)
7029
(NNT = 365 to infinity;
NNH = 331 to infinity)

Citation

  1. Maggioni AP, Franzosi MG, Santoro E, et al: The risk of stroke in patients with acute myocardial infarction after thrombolytic and antithrombotic treatment. New England Journal of Medicine 1992; 327 (1): 1-6
Contributor: Clare Wotton, February 2000
Reviewer: Chris Ball

Clinical Question.
Patient myocardial infarction
Intervention or Exposure streptokinase
Comparison tissue plasminogen activator
Outcome stroke