Thrombolysis with saruplase versus streptokinase in acute myocardial infarction: five-year results of the PRIMI trial.
BACKGROUND
Short-term safety and efficacy of thrombolysis with saruplase in acute myocardial infarction have been shown in several trials. To assess long-term outcome of patients treated with saruplase or streptokinase for myocardial infarction, a 5-year follow-up of patients included in the Pro-Urokinase in Myocardial Infarction Trial was performed.


RESULTS
Follow-up data are available from 8 centers on 255 (92.4%) of 276 included patients. The 5-year mortality rate was comparable with 20.8% of patients in the saruplase group and 16.9% in the streptokinase group (odds ratio 1.29, 95% confidence interval 0.69 to 2.42). In both groups, a considerable number of fatal cardiovascular events occurred more than 1 year after study inclusion. Rates of percutaneous transluminal coronary angioplasty and coronary artery bypass grafting were comparable in both groups. Reinfarction within 5 years occurred in 19.0% of patients in the saruplase group and tended to be less frequent at 10.8% after streptokinase treatment (odds ratio 1.94, 95% confidence interval 0.98 to 3.84). In both groups, the majority of reinfarctions took place more than 3 months after study inclusion. The 5-year stroke rate was 3.6% and 7.2% in the saruplase and streptokinase groups, respectively (odds ratio 0.49, 95% confidence interval 0.16 to 1.47). Subjective symptoms of heart failure and angina pectoris were comparable in both groups.


CONCLUSIONS
Our data are consistent with a similar long-term outcome for patients treated with saruplase or streptokinase. Despite the low-risk profile of the patient cohort, there were considerable adverse event rates over a 5-year period.
Spiecker
M
M
Department of Cardiology, University of Mainz, Germany. spiecker@mail.uni-mainz.de
Windeler
J
J
Vermeer
F
F
Michels
R
R
Seabra-Gomes
R
R
vom Dahl
J
J
Kerber
S
S
Verheugt
F W
FW
Westerhof
P W
PW
Bär
F W
FW
Nixdorff
U
U
Barth
H
H
Hopkins
G R
GR
von Fisenne
M J
MJ
Meyer
J
J
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000706:statistics & numerical data; D002561:Cerebrovascular Disorders / Q000453:epidemiology; D015331:Cohort Studies; D001026:Coronary Artery Bypass / Q000706:statistics & numerical data; D005260:Female; D005343:Fibrinolytic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy*; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012008:Recurrence; D013300:Streptokinase / Q000009:adverse effects / Q000627:therapeutic use*; D016019:Survival Analysis; D015912:Thrombolytic Therapy; D014568:Urokinase-Type Plasminogen Activator / Q000009:adverse effects / Q000627:therapeutic use*
D005343:Fibrinolytic Agents; D011994:Recombinant Proteins; D013300:Streptokinase; D014568:Urokinase-Type Plasminogen Activator; C067551:saruplase