e0632 A randomised comparison study of recombinant staphylokinase vs recombinant tissue-type tissue plasminogen activator for safety and coronary artery patency in patients with acute myocardial infarction

Objective To evaluate the efficacy and safety of r-SAK (recombinant staphylokinase) for acute ST-segment elevation myocardial infarction (STEMI). Methods A total of 48 patients with acute STEMI randomised into r-SAK group and r-tPA group (each with 24 patients). In r-SAK group, 10mg r-SAK diluted up to 50ml with saline before administration, 2mg bolus over 2 min, followed by an infusion of the remaining 8mg over 30 min. While in r-tPA group, first 8mg bolus over 6 min, then 42 mg over a 90-min period. A 75U/kg heparin bolus was given as r-SAK or r-tPA was infusing for anti-coagulation treatment. CAG were performed at 90 min to confirm infarction location and IRA, stenosis was analysed by QCA, IRA flow was evaluated by TIMI grades, myocardial tissue reperfusion was assessed by TMPG. Acute complications and adverse events were recorded during 30 days after thrombolysis. Results There was no significant difference in baseline data between r-SAK and r-tPA group. There was no difference in IRA distribution between the two groups, the IRA repatency rate (p=0.308), TIMI 3 flow (p=0.355), myocardial tissue reperfusion (p=0.530) in r-SAK group are slightly higher than those in r-tPA group, but the differences was not significant. The acute complications during 30-day period after thrombolysis, include allergic reaction (p=0.317), serious arrhythmias (p=0.775), heart failure (p=0.530), cardiac shock (p=1.000), IRA re-occluded (p=0.555), postinfarction angina (p=0.734) and death (p=0.317), have no significant difference between the two groups. The bleeding complications of r-SAK group were slightly less (p=0.125). No statistic difference in adverse events was found between the two groups. Conclusions r-SAK proved to be at least as effective as alteplase in inducing early coronary artery patency for STEMI with higher fibrin specificity than r-tPA, r-SAK, and less bleeding complications. The safety of r-SAK thrombolysis therapy is at about the same level of that of r-tPA, not associate with excess mortality and complications of arrhythmia, postinfarction angina and haemorrhage.