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Updated: Jul 5, 2025
Prehospital Thrombolysis: A Manual from Berlin
Published on: November 26, 2013
Single Bolus r-SAK Before Primary PCI for ST-Segment-Elevation Myocardial Infarction
Pengsheng Chen1,2, John W Eikelboom3, Chunyue Tan1
1Departments of Cardiology (P.C., C.T., W.Z., T.W., X.G., K.L., J.M., Z.D., Chen Li, J. Zong, F.Z., J.H., X.K., Chunjian Li), the First Affiliated Hospital of Nanjing Medical University, China.
Insights
Adjunctive thrombolysis with recombinant staphylokinase (r-SAK) before percutaneous coronary intervention (PCI) improved artery patency and reduced infarct size in ST-segment-elevation myocardial infarction patients. This treatment did not increase major bleeding events.
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.
Background:
It is uncertain whether adjunctive thrombolysis is beneficial for patients with ST-segment-elevation myocardial infarction undergoing percutaneous coronary intervention (PCI) within 120 minutes of presentation. This study was to determine whether in patients presenting with ST-segment-elevation myocardial infarction a single bolus recombinant staphylokinase (r-SAK) before timely PCI leads to improved patency of the infarct-related artery and reduces the infarct size.
Methods:
This is an open-label, prospective, multicenter, randomized study. We enrolled patients aged 18 to 75 years who were within 12 hours of symptom onset of ST-segment-elevation myocardial infarction and expected to undergo PCI within 120 minutes. Patients were administered loading doses of aspirin and ticagrelor and intravenous heparin and were randomized to receive 5 mg bolus of r-SAK or normal saline intravenously before PCI. The primary end point was Thrombolysis in Myocardial Infarction flow grade 2 to 3 or grade 3 in the infarct-related artery 60 minutes after thrombolysis. The infarct size was detected by cardiac magnetic resonance 5 days after randomization. The safety end point was major bleeding (Bleeding Academic Research Consortium ≥3) during 30-day follow-up.
Results:
A total of 283 patients were screened from 8 centers and 200 were randomized (median age, 58.5 years; 14% female). The median symptom to thrombolysis time was 252.5 (interquartile range, 142.8-423.8) minutes and thrombolysis to coronary arteriography was 50.0 (interquartile range, 37.0-66.0) minutes. Patients randomized to r-SAK compared with normal saline more often had Thrombolysis in Myocardial Infarction flow grade 2 to 3 (69.0% versus 29.0%; P<0.001) and Thrombolysis in Myocardial Infarction flow grade 3 (51.0% versus 18.0%; P<0.001) and had smaller infarct size (21.91±10.84% versus 26.85±12.37%; P=0.016). There was no increase in major bleeding (r-SAK, 1.0% versus control, 3.0%; P=0.616).
Conclusions:
A single bolus r-SAK before primary PCI for ST-segment-elevation myocardial infarction improves infarct-related artery patency and reduces infarct size without increasing major bleeding.
Registration:
URL: https://www.clinicaltrials.gov; Unique identifier: NCT05023681.
