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