Efficacy of Two Streptokinase Formulations in Acute Myocardial Infarction: A Double-Blind Randomized Clinical Trial

Abstract

Background: We sought to evaluate the efficacy and safety of the different trade forms of streptokinase available in our country, namely Heberkinasa (Heberbiotec, Havana, Cuba) and Streptase (Aventis Behring GmbH, Marburg, Germany).

Methods: We conducted a double-blind randomized clinical trial to compare the two streptokinase formulations, i.e. Heberkinasa (HBK) or Streptase (STP), in patients with acute myocardial infarction who needed thrombolysis. Thrombolysis success was evaluated angiographically and/or clinically. Clinical follow-up was done 30 days after thrombolysis.

Results: We randomly allocated 221 patients with a mean age of 56.9±10.8 years (males: 88.2%) to HBK (n=119) and STP (n=102) groups. Baseline clinical and demographic characteristics were similar between the two groups, and the two groups were not significantly different in terms of door-to-needle and pain-to-needle intervals. The rate of complications was not significantly different between the groups (44.1% [HBK] vs. 42% [STP]). Angiography was done for 158 (71.5 %) patients in the first 24 hours (9%) and in the first 72 hours (38.8%) after thrombolysis. Lesion morphology and lesion/patient ratio were not significantly different between the two groups (1.87[HBK] vs. 1.67[STP]). The two groups were similar with respect to angiographic patency rate (67.5% [HBK] vs. 67.6% [STP]). The study groups were also similar as regards clinical outcome and complications of both streptokinase formulations. 

Conclusion: The present study demonstrated that Heberkinasa is as effective and as safe as a standard streptokinase, namely Streptase, in a clinical setting.