Recombinant streptokinase versus urokinase in pulmonary embolism :A a randomized, multi-center, controlled trial

Rationale Recombinant streptokinase (r-SK) is an effective thrombolytic agent developed with gene engineering, but it is unclear whether r-SK can be used in patients with pulmonary embolism (PE). The aim of this study was to compare the efficacy and safety of r-SK with urokinase (UK) in selected PE patients. Methods We enrolled consecutive massive and submassive PE patients at 8 hospitals in China between June, 2006 and March, 2009. The patients were divided into two groups randomly to receive (1) 150 million IU r-SK by 2 hours infusion or (2) 20,000 IU/kg UK by 2 hours infusion. After thrombolysis, the patients received low molecular weight heparin and oral treatment with warfarin to maintain an INR of 2-3. The mortality and PE recurrence in 14-day and 3-month, major bleeding and anaphylaxis were observed. Results of 83 patients enrolled (including 11 massive PE), 42 were randomly assigned to receive r-SK and 41 to receive UK. The two groups had similar pretreatment clinical, haemodynamic, echocardiographic and CT characteristics. Fourteen days after thrombolysis, there was only one patient dead in each group respectively. The mortality of r-SK and UK group in 3-month was 2.4% vs 8.3%, p=0.33. The 14-day PE recurrence rate of r-SK and UK group was 2.4% vs 0%, while 5.3% vs 2.9% in 3-month. There were no significant differences between the two groups. There were 2 major bleeding in UK group, including an intracerebral bleeding. However, no major bleeding occurred in r-SK group. UK group only had one anaphylactic tetter case. There was no significant difference in fever between the two groups. Conclusions The domestic r-SK is equally effective and safe as UK in massive and submassive PE.