Collaborative Angiographic Patency Trial Of Recombinant Staphylokinase (CAPTORS II).
OBJECTIVE
A fibrinolytic agent more effective than streptokinase available for bolus injection with reasonable cost-effectiveness is a desirable goal. Pilot studies with bolus pegulated staphylokinase (PEG-Sak) have revealed excellent Thrombolysis In Myocardial Infarction (TIMI) 3 60-minute flow.


RESULTS
We evaluated patients with acute ST-elevation myocardial infarction within 6 hours of chest pain onset to determine a dose of PEG-Sak that had at least equal efficacy to recombinant tissue plasminogen activator (rt-PA) while maintaining an acceptable safety profile. After the initial study of 38 patients, of whom 27 received PEG-Sak, enrollment was temporarily halted because 3 patients receiving PEG-Sak had intracranial hemorrhage: 1 at a dose of 0.15 mg/kg and 2 at a dose of 0.05 mg/kg. Overall, 378 patients were studied across a PEG-Sak dose range from 0.01 mg/kg to 0.015 mg/kg, and 122 patients received accelerated rt-PA. At the lowest dose of PEG-Sak studied, 0.01 mg/kg, there was suggestive evidence of attenuation of efficacy; the point estimate for TIMI 3 flow was 24% (95% CI 9%-38%). At doses of 0.01875 to 0.0375 mg/kg (n = 314), TIMI 3 flow rates were 33% (95% CI 27%-38%), whereas the TIMI 3 flow was 41% (95% CI 20%-61%) at the highest PEG-Sak dose studied, 0.05 mg/kg (n = 23), which was similar to that found with rt-PA, 41% (95% CI 32%-50%).


CONCLUSIONS
The efficacy of PEG-Sak, coupled with its ease of administration, provide further impetus for further study in acute myocardial infarction.
Armstrong
P W
PW
University of Alberta, Edmonton, Alberta, Canada. paul.armstrong@ualberta.ca
Burton
J
J
Pakola
S
S
Molhoek
P G
PG
Betriu
A
A
Tendera
M
M
Bode
C
C
Adgey
A A J
AA
Bar
F
F
Vahanian
A
A
Van de Werf
F
F
D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008666:Metalloendopeptidases / Q000008:administration & dosage*; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy*; D018709:Statistics, Nonparametric; D013300:Streptokinase / Q000008:administration & dosage*; D015912:Thrombolytic Therapy; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage*
D005343:Fibrinolytic Agents; D013300:Streptokinase; D010959:Tissue Plasminogen Activator; D008666:Metalloendopeptidases; C022653:auR protein, Staphylococcus aureus