Clinical efficacy and safety of intracoronary prourokinase during percutaneous coronary intervention in patients with ST elevation myocardial infarction: a patient pooled meta-analysis of clinical trials

  AIM   To evaluate the clinical efficacy and safety of recombinant human urokinase (RH pro-UK) in patients with acute ST elevation myocardial infarction.

  METHODS  Nine articles were included, all of which were RCT tests, with a total of 1291 people, 638 in the drug group and 653 in the control group. The inclusion criteria were patients diagnosed as acute ST segment elevation myocardial infarction. For literature retrieval, two researchers independently screened the literature, submitted the data and cross checked them. In case of disagreement, it was discussed and resolved, or the third researcher assisted in judgment. RevMan5.4 and Stata17.0 were used for software statistical meta-analysis for statistical analysis. Relative risk (RR) was used as the outcome indicator of secondary variables, and weighted mean difference (WMD) was used as the effect indicator for continuous variables. Point estimates and 95% CI were given for each indicator. When P>0.05 and I2<0.5, the fixed effect model was used for meta analysis. Main end point Major adverse cardiovascular events (MACE) during follow-up (including cardiac death, recurrent myocardial infarction and congestive heart failure). Secondary end point: coronary microcirculation obstruction after PCI (including TIMI3, cTFC score, MBG 3 and ECG ST segment fall rate>50%); Left ventricular ejection fraction (LVEF) at 1 month, 3 months and >6 months during follow-up; Safety end point: incidence of bleeding during follow-up.

  RESULTS  There was a statistically significant difference in the total major adverse cardiovascular events (MACE) between the drug group (7.1%) and the control group (11.2%) (RR: 0.63, 95% CI: 0.44～0.89, P<0.01, I²=0%). There was a statistically significant difference between the drug group (7.6%) and the control group (12.5%) (RR: 0.61, 95% CI: 0.37～0.99, P<0.05, I²=0%) for MACE events more than 6 months. There was no significant difference among the treatment groups of cardiac death, recurrent myocardial infarction and congestive heart failure. In the sub groups of medium and low quality literature analysis of different quality literature, 7.1% of the MACE event medication group and 14.5% of the control group (RR: 0.50, 95% CI: 0.27～0.90, P<0.05, I²=0%), the total literature difference was P<0.05, and the difference was statistically significant. There was no significant difference in high-quality literature. The secondary end points, myocardial infarction blood flow grade 3 (TIMI, P<0.01), corrected TIMI frame count (cTFC, P<0.01), myocardial blue grade (MBG, P<0.05), and ECG ST segment regression >50% (P<0.01) were statistically significant. The left ventricular ejection fraction in January, March and > June in the drug group was higher than that in the control group (all P<0.01). There was no statistical difference in the incidence of bleeding at the safe end point between the two groups.

  CONCLUSION  Intracoronary prourokinase during PCI improves microvascular obstruction after PCI, reduces the incidence of MACE and congestive heart failure, and improves LVEF in patients with ST elevation myocardial infarction during follow-up.