Multicenter, randomized, comparative study of recombinant vs. natural streptokinases in acute myocardial infarct (TERIMA)

Aim: To compare the effects on hemostasis and coronary patency of recombina nt (rSK) and natural (nSK) streptokinases in patients with acute myocardial infarct (AMI), Methods: Patients from 7 hospitals, <70 years old, less tha n 12 h after the onset of AMI symptoms, with ST segment elevation or bundle branch block, without contraindications for thrombolytic therapy, were ran domized to receive 1.5 million units of nSK or rSK in a one-hour intravenou s infusion. Fibrinogen, fibrinogen degradation products (FDP) and thrombin time were monitored. A coronary angiography was performed after 5-10 days i n those patients who gave their consent and did not refer allergy to iodine contrasts. Images were blindly evaluated by an independent committee. Resu lts: 224 patients were randomized (113 nSK and 111 rSK). Groups were equiva lent in all baseline and demographic variables except that rSK patients wer e 5.4 years significantly older. They were also comparable in all the clini cal characteristics. Both treatments produced the same changes in hemostasi s. Fibrinogen levels decreased, FDP and thrombin time increased immediately after thrombolysis and returned to baseline 2 days afterwards, but fibrino gen 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). H ypotension and arrhythmias were the most frequent adverse events in both gr oups, which did not differ in this respect either. Five patients from each group died, one of them (nSK) due to gastroduodenal bleeding probably relat ed to treatment. Conclusions: rSK behaved similarly to nSK regarding corona ry patency at 8 days after thrombolysis and the changes induced on fibrinog en, 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 .