Multicenter, randomized, comparative study of recombinant vs. natural streptokinases in acute myocardial infarct (TERIMA).
OBJECTIVE
To compare the effects on hemostasis and coronary patency of recombinant (rSK) and natural (nSK) streptokinases in patients with acute myocardial infarct (AMI).


METHODS
Patients from 7 hospitals, <70 years old, less than 12 h after the onset of AMI symptoms, with ST segment elevation or bundle branch block, without contraindications for thrombolytic therapy, were randomized to receive 1.5 million units of nSK or rSK in a one-hour intravenous infusion. Fibrinogen, fibrinogen degradation products (FDP) and thrombin time were monitored. A coronary angiography was performed after 5-10 days in those patients who gave their consent and did not refer allergy to iodine contrasts. Images were blindly evaluated by an independent committee.


RESULTS
224 patients were randomized (113 nSK and 111 rSK). Groups were equivalent in all baseline and demographic variables except that rSK patients were 5.4 years significantly older. They were also comparable in all the clinical characteristics. Both treatments produced the same changes in hemostasis. Fibrinogen levels decreased, FDP and thrombin time increased immediately after thrombolysis and returned to baseline 2 days afterwards, but fibrinogen values continued to increase up to day 10. Coronary patency (TIMI 2-3) rates at 7.8+/-2.7 and 8.0+/-2.7 days after fibrinolysis were 70.7% and 67.1% for nSK and rSK groups, respectively (non-significant difference). Hypotension and arrhythmias were the most frequent adverse events in both groups, which did not differ in this respect either. Five patients from each group died, one of them (nSK) due to gastroduodenal bleeding probably related to treatment.


CONCLUSIONS
rSK behaved similarly to nSK regarding coronary patency at 8 days after thrombolysis and the changes induced on fibrinogen, FDP and thrombin time. These results suggest that the same benefit/risk profile reported for AMI patients treated with nSK can be expected for rSK.
Center for Biological Research, Clinical Trial Division, Havana, Cuba.
D000208:Acute Disease; D000328:Adult; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000503:physiopathology; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D013300:Streptokinase / Q000008:administration & dosage* / Q000009:adverse effects
D005343:Fibrinolytic Agents; D011994:Recombinant Proteins; D013300:Streptokinase