Objective: The aim of the study was to compare the safety and clinical efficacy of recombinant staphylokinase (r-Sak) with recombinant tissue-type plasminogen activator (rt-PA) in patients with acute myocardial infarction (AMI).
Methods: This multicenter, open-label, randomized, parallel trial was conducted in 12 hospitals from January 2002 to October 2003. Patients (age < or = 70 years) with ST segment elevated AMI admitted within 12 hours of symptom onset were randomized to r-Sak (3 mg bolus followed by 12 mg intravenous infusion for 30 minutes, n = 104) or rt-PA (8 mg bolus followed by 42 mg intravenous infusion for 90 minutes, n = 106). All patients received aspirin and intravenous heparin and underwent angiography to determine infarct related artery (IRA) patency 90 minutes after drug therapy. Rescue percutaneous coronary intervention (PCI) was performed for patients with TIMI grade < or = 2.
Results: The IRA patency (TIMI grade 2 or 3), the primary end-point, was significantly higher in r-Sak group than that in rt-PA group (77.8% vs. 63.6%, P = 0.0277), the TIMI grade 3 flow was similar between the two groups (57.6% vs. 48.5%, P = 0.1929). One month post therapy, rates of death (8.7% vs. 5.7%, P = 0.3997), non-fatal myocardial infarction (2.9% vs. 3.8%, P = 1.0000), recurrent myocardial ischemia (8.7% vs. 16.0%, P = 0.1043) and composite clinical end-point (18.3% vs. 21.7%, P = 0.5345) were similar between the two groups. Hemorrhage occurred in 28.8% of patients receiving r-Sak and 27.4% of patients receiving rt-PA (P = 0.8105), severe and life-threatening hemorrhage rate (1.9% vs. 3.8%) as well as hemorrhagic stroke rate (0.96% vs.3.85%) were also no significant difference between the two groups. No anaphylactic reaction and other severe adverse events related to drug therapy were noted.
Conclusion: The r-Sak is a safe and effective thrombolytic agent comparable to rt-PA for treatment of AMI.