Key result
Intracoronary prourokinase reduces 12-month MACE ~78% vs saline during emergency STEMI PCI.
Why the study?
It was unknown whether intracoronary recombinant human prourokinase improves coronary blood flow, attenuates post-reperfusion inflammatory responses, and enhances clinical outcomes in patients with acute myocardial infarction.
Does intracoronary recombinant human prourokinase reduce major adverse cardiovascular events in STEMI patients undergoing primary PCI?
RCT (n=136)
Single-blind
1:1:1
No
Does intracoronary recombinant human prourokinase reduce major adverse cardiovascular events in STEMI patients undergoing primary PCI?
Intracoronary administration of recombinant human prourokinase via a perforated balloon during primary PCI for STEMI significantly reduces the risk of major adverse cardiovascular events at 1 year.
Supports intracoronary rhPro-UK during primary PCI for STEMI; extends adjunctive options to reduce MACE.
Background:This study aimed to investigate whether intracoronary administration of recombinant human prourokinase (rhPro-UK) improves coronary blood flow, attenuates post-reperfusion inflammatory responses, and enhances clinical outcomes in patients with acute myocardial infarction.Methods:In this prospective, single-blind, randomized, controlled clinical trial, 136 ST-segment elevation myocardial infarction (STEMI) patients undergoing emergency percutaneous coronary intervention (PCI) at Anqing Municipal Hospital (August 2021–June 2023) were randomized 1:1:1 to intracoronary rhPro-UK (n = 44), tirofiban (n = 44), or saline groups (n = 48). Perioperative serum levels of creatine kinase-MB (CK-MB), high-sensitivity cardiac troponin T (hs-cTnT), interleukin-6 (IL-6), interleukin-8 (IL-8), tumor necrosis factor-alpha (TNF-α), and soluble suppression of tumorigenicity-2 (sST2) were measured. Serum sST2 was re-evaluated at 1 month (28 ± 7 days) post-PCI. Major adverse cardiovascular events (MACE) were assessed via clinic visits or telephone follow-up at 12 months.Results:The cohort had a mean age of 60.6 ± 11.5 years and was predominantly male (89.0%). At 12 months, the rhPro-UK group had the lowest MACE incidence (log-rank p = 0.039). Multivariable Cox regression confirmed reduced MACE risk in the rhPro-UK group (hazard ratio [HR] 0.22, 95% confidence interval [CI]: 0.05–0.99, p = 0.049). The final intra- and postoperative corrected TIMI frame count (cTFC) results demonstrated that both the tirofiban group and the rhPro-UK group exhibited superior efficacy in alleviating the slow/no-reflow phenomenon compared with the saline control group. At 48 hours post-PCI, rhPro-UK significantly reduced CK-MB and hs-cTnT levels compared to saline (p < 0.05). Both rhPro-UK and tirofiban groups exhibited lower IL-6, IL-8, and TNF-α levels at 24, 48, and 72 hours (p < 0.05). At 1-month follow-up, sST2 levels were markedly reduced in the rhPro-UK group (12.9 ± 3.3 pg/mL) versus tirofiban (18.7 ± 4.9 pg/mL) and saline (24.4 ± 15.7 pg/mL) (p = 0.001).Conclusion:Intracoronary rhPro-UK administration during emergency PCI in STEMI patients reduces post-reperfusion inflammation and fibrosis, limits infarct size, and improves clinical outcomes.Trial Registration:Chinese Clinical Trial Registry (ChiCTR; http://www.chictr.org.cn; Identifier: ChiCTR2100047095).
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Gu et al. (2026) conducted an RCT in ST-segment elevation myocardial infarction (STEMI) (n=136). Intracoronary recombinant human prourokinase (rhPro-UK) vs. Saline or tirofiban was evaluated on Major Adverse Cardiovascular Events (MACE) at 12 months post-PCI (HR 0.22, 95% CI 0.05-0.99, p=0.049). Intracoronary administration of recombinant human prourokinase during emergency PCI in STEMI patients significantly reduced the risk of major adverse cardiovascular events at 12 months compared to saline (HR 0.22).
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