OBJECTIVES: To evaluate the efficacy and safety of intracoronary administration of prourokinase via balloon catheter during primary percutaneous coronary interventions (PCI) in patients with acute ST-segment elevation myocardial infarction (STEMI). METHODS:Acute STEMI patients underwent primary PCI were randomly divided into two groups: intracoronary prourokinase (IP) group (n = 118) and control group (n = 112). During primary PCI, prourokinase or saline were injected to the distal end of the culprit lesion via balloon catheter after balloon catheter dilatation. Demographic and clinical characteristics, infarct size, myocardial reperfusion, and cardiac functions were evaluated and compared between two groups. Hemorrhagic complications and MACE occurred in the 6-months follow up were recorded. RESULTS:No significant differences were observed between two groups with respect to baseline demographic, clinical, and angiographic characteristics (P > 0.05). In IP group, more patients had complete ST segment resolution (>70%) compared with control group (P < 0.05). Patients in IP group showed lower levels of serum CK, CK-MB and TnI, and a much higher myocardial blood flow (MBF) than those in control group (P < 0.05). No significant differences of TIMI major or minor bleeding complications were observed between the two groups (P > 0.05). At 6-months follow-up, there was a trend that patients in the IP group had a less chance to have MACE, though it was not statistically different (8.5% vs 12.5%, P > 0.05). CONCLUSIONS: Intracoronary administration of prourokinase via balloon catheter during primary PCI effectively improved myocardial perfusion in STEMI patients.
RCT Entities:
OBJECTIVES: To evaluate the efficacy and safety of intracoronary administration of prourokinase via balloon catheter during primary percutaneous coronary interventions (PCI) in patients with acute ST-segment elevation myocardial infarction (STEMI). METHODS: Acute STEMI patients underwent primary PCI were randomly divided into two groups: intracoronary prourokinase (IP) group (n = 118) and control group (n = 112). During primary PCI, prourokinase or saline were injected to the distal end of the culprit lesion via balloon catheter after balloon catheter dilatation. Demographic and clinical characteristics, infarct size, myocardial reperfusion, and cardiac functions were evaluated and compared between two groups. Hemorrhagic complications and MACE occurred in the 6-months follow up were recorded. RESULTS: No significant differences were observed between two groups with respect to baseline demographic, clinical, and angiographic characteristics (P > 0.05). In IP group, more patients had complete ST segment resolution (>70%) compared with control group (P < 0.05). Patients in IP group showed lower levels of serum CK, CK-MB and TnI, and a much higher myocardial blood flow (MBF) than those in control group (P < 0.05). No significant differences of TIMI major or minor bleeding complications were observed between the two groups (P > 0.05). At 6-months follow-up, there was a trend that patients in the IP group had a less chance to have MACE, though it was not statistically different (8.5% vs 12.5%, P > 0.05). CONCLUSIONS: Intracoronary administration of prourokinase via balloon catheter during primary PCI effectively improved myocardial perfusion in STEMI patients.