Single bolus recombinant staphylokinase beneficial for STEMI patients undergoing PCI: Circulation

Time to reperfusion is critical in treating patients with ST-elevation myocardial infarction (STEMI). The benefit of adjunctive thrombolysis for patients with STEMI undergoing PCI within 120 minutes of presentation is uncertain. Therefore, Pengsheng Chen, Department of Cardiology, Xuzhou Central Hospital, Jiangsu, China (P.C.), and colleagues aimed to determine whether a single bolus recombinant staphylokinase before timely PCI leads to improved patency of the infarct-related artery and reduces the infarct size in patients presenting with ST-segment–elevation myocardial infarction.

For this purpose, the researchers conducted an open-label, prospective, multicenter, randomized study (OPTIMA-5). They enrolled patients aged 18 to 75 years who were within 12 hours of symptom onset of STEMI and expected to undergo PCI within 120 minutes.

Patients were administered loading doses of aspirin and ticagrelor and intravenous (IV) heparin and were randomized to receive a 5 mg bolus of r-SAK or normal saline intravenously before PCI.

The study's primary endpoint was Thrombolysis in Myocardial Infarction flow grade 2 to 3 or grade 3 in the infarct-related artery 60 minutes after thrombolysis. Cardiac magnetic resonance was used to detect infarct size five days after randomization. During the 30-day follow-up, the safety endpoint was major bleeding (Bleeding Academic Research Consortium ≥3).

283 patients were screened from 8 centres, and 200 were randomized (median age, 58.5 years; 14% female).

Based on the study, the researchers reported the following findings:

• The median symptom to thrombolysis time was 252.5 minutes and thrombolysis to coronary arteriography was 50.0 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%) and Thrombolysis in Myocardial Infarction flow grade 3 (51.0% versus 18.0%) and had smaller infarct size (21.91±10.84% versus 26.85±12.37%).
• There was no increase in major bleeding (r-SAK, 1.0% versus control, 3.0%).

"A single bolus r-SAK before primary PCI for ST-segment–-elevation myocardial infarction reduces infarct size and improves infarct-related artery patency without increasing major bleeding," the researchers concluded.

Reference:

The study titled, "Single Bolus r-SAK Before Primary PCI for ST-Segment–Elevation Myocardial Infarction," was published online in Circulation: Cardiovascular Interventions. DOI: https://doi.org/10.1161/CIRCINTERVENTIONS.123.013455