Single Bolus r-SAK Before Primary PCI for ST-Segment-Elevation Myocardial Infarction

Area of Science:

• Cardiology
• Interventional Cardiology
• Emergency Medicine

Background:

• Uncertainty exists regarding the benefit of adjunctive thrombolysis for ST-elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention (PCI) within 120 minutes.
• This study investigated the efficacy of recombinant staphylokinase (r-SAK) as an adjunctive therapy before PCI.

Purpose of the Study:

• To determine if a single bolus of r-SAK before timely PCI improves infarct-related artery patency.
• To assess the impact of r-SAK on infarct size.
• To evaluate the safety of r-SAK concerning major bleeding.

Main Methods:

• An open-label, prospective, multicenter, randomized study involving 200 STEMI patients.
• Patients received aspirin, ticagrelor, and heparin, then randomized to r-SAK or normal saline before PCI.
• Primary endpoint: Thrombolysis in Myocardial Infarction (TIMI) flow grade in the infarct-related artery. Secondary endpoint: Infarct size by cardiac MRI; safety endpoint: major bleeding.

Main Results:

• Patients receiving r-SAK showed significantly higher rates of TIMI flow grade 2-3 (69.0% vs. 29.0%) and grade 3 (51.0% vs. 18.0%) compared to the control group (P<0.001).
• Adjunctive r-SAK led to a smaller infarct size (21.91±10.84% vs. 26.85±12.37%; P=0.016).
• No significant increase in major bleeding was observed between the r-SAK group (1.0%) and the control group (3.0%; P=0.616).

Conclusions:

• A single bolus of r-SAK administered before primary PCI in STEMI patients improves infarct-related artery patency.
• r-SAK treatment effectively reduces infarct size.
• The use of r-SAK in this setting is safe, with no increase in major bleeding complications.