RESUMO
Objective: To evaluate the efficacy and safety of intravenous thrombolytic therapy using reteplase in patients with acute ST-segment elevation myocardial infarction (STEMI). Method: A total of 73 hospitals from Henan province took part in this clinical trials during October 2012 to October 2014, 1 226 cases (1 014 male (82.7%), mean age 59.0 (51.0, 66.0) years) with acute STEMI received reteplase as thrombolytic agent.Reperfusion rate was judged according to the clinical symptoms, electrocardiogram, myocardial enzymes and heart rhythm, and the rate of cardiovascular events and bleeding events during hospitalization was also observed.Bleeding events were evaluated with global utilization of streptokinase and tissues plasminogen activator for occluded coronary arteries (GUSTO) criteria.Subgroup analysis was performed to compare the effects of various thrombolysis timing (time from onset to thrombolysis≤6 h or 6-12 h) on reperfusion rate, cardiovascular events and bleeding events rate. Results: The reperfusion rate was 89.3% (1 089/1 219) at 120 minutes after the thrombolysis, average recanalization time was (59.96±26.86) minutes.The reperfusion rate of ≤6 h thrombolysis group was significantly higher than in 6-12 hours group (90.3% (988/1094) vs. 80.8% (101/125), P=0.001), while in-hospital mortality (2.6%(28/1 094) and 0.8% (1/125), P=0.352) and rate of bleeding (5.9%(64/1 094) and 5.6%(7/125), P=0.910) were similar between the two groups. The total in-hospital mortality after thrombolysis was 2.4% (29/1219), which was significantly higher in failed recanalization group than in recanalization group (10.8%(14/130) vs. 1.4%(15/1089), P< 0.001). The total rate of bleeding after thrombolysis was 5.8% (71/1219), there were 3 severe bleeding cases according to GUSTO classification (0.2%), all of them were cerebral hemorrhage, and 2 out of 3 cases died. Conclusions: Reteplase use is related to high recanalization rate and low cardiovascular events and bleeding rate and our results thus show that reteplase is a safe and effective thrombolytic agent for STEMI patients.