Efficacy and safety of intracoronary pro-urokinase combined with low-pressure balloon pre-dilatation during percutaneous coronary intervention in patients with anterior ST-segment elevation myocardial infarction

J Cardiothorac Surg. 2024 Apr 5;19(1):180. doi: 10.1186/s13019-024-02699-7.

Abstract

Background: The efficacy and safety of low-pressure balloon pre-dilatation before intracoronary pro-urokinase (pro-UK) in preventing no-reflow during percutaneous coronary intervention (PCI) remains unknown. This study aimed to evaluate the clinical outcomes of intracoronary pro-UK combined with low-pressure balloon pre-dilatation in patients with anterior ST-segment-elevation myocardial infarction (STEMI).

Methods: This was a randomized, single-blind, investigator-initiated trial that included 179 patients diagnosed with acute anterior STEMI. All patients were eligible for PCI and were randomized into two groups: intracoronary pro-UK combined with (ICPpD group, n = 90) or without (ICP group, n = 89) low-pressure balloon pre-dilatation. The main efficacy endpoint was complete epicardial and myocardial reperfusion. The safety endpoints were major adverse cardiovascular events (MACEs), which were analyzed at 12 months follow-up.

Results: Patients in the ICPpD group presented significantly higher TIMI myocardial perfusion grade 3 (TMPG3) compared to those in the ICP group (77.78% versus 68.54%, P = 0.013), and STR ≥ 70% after PCI 30 min (34.44% versus 26.97%, P = 0.047) or after PCI 90 min (40.0% versus 31.46%, P = 0.044). MACEs occurred in 23 patients (25.56%) in the ICPpD group and in 32 patients (35.96%) in the ICP group. There was no difference in hemorrhagic complications during hospitalization between the groups.

Conclusion: Patients with acute anterior STEMI presented more complete epicardial and myocardial reperfusion with adjunctive low-pressure balloon pre-dilatation before intracoronary pro-UK during PCI.

Trial registration: 2019xkj213.

Keywords: Efficacy; PCI; Pro-urokinase; STEMI; Safety.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Dilatation
  • Humans
  • Percutaneous Coronary Intervention* / adverse effects
  • Recombinant Proteins
  • ST Elevation Myocardial Infarction* / surgery
  • Single-Blind Method
  • Treatment Outcome
  • Urokinase-Type Plasminogen Activator*

Substances

  • saruplase
  • Recombinant Proteins
  • Urokinase-Type Plasminogen Activator