One-year outcomes of a single bolus r-SAK before primary PCI for STEMI:Follow-up of the OPTIMA-5 study
Chen Li
Jie Yu
Tian Wu
Qingxia Lin
Rui Hua
Zihang Zhong
Yule Li
Kun Liu
Li Zhu
Naiquan Yang
Xin Chen
Xiaoyan Wang
Xin Zhao
Jun Jiang
Bo Zhao
Xiwen Zhang
Pengsheng Chen
Tong Wang
Yi Xu
Gaoyong Liao
Liang Yuan
Bo Chen
Zhihui Xu
Xiaoxuan Gong
Wenhao Zhang
Chunyue Tan
Lei Xu
Qiang Huang
Jianling Bai
John W.Eikelboom
Chunjian Li
Abstract：The Optimal Management of Antithrombotic and Thrombolytic Agents-5 (OPTIMA-5) study demonstrated that a single bolus of half the standard dose of recombinant staphylokinase (r-SAK) before primary percutaneous coronary intervention (PCI) significantly improved the patency of the infarct-related artery in patients with ST-segment elevation myocardial infarction (STEMI), who were expected to undergo PCI within 120 min. The present study aimed to investigate the one-year clinical outcomes and the effect of the anti-r-SAK antibodies on a second r-SAK thrombolysis in OPTIMA-5 patients. The clinical outcome measured was major adverse cardiovascular events (MACE) within 360 days. Patients' anti-r-SAK antibody levels were determined on day 90 (±7 days), day 180 (±7 days), and day 360 (±14 days) after thrombolysis, and in vitro r-SAK antibody neutralization experiments were performed to explore an optimal interval for a second r-SAK thrombolysis. Results showed that the MACE incidence was numerically lower in the r-SAK group compared with the normal saline (NS) group (14.0% vs. 20.0%, hazard ratio [HR] = 0.67, 95% confidence interval [CI]: 0.34–1.32; log-rank P = 0.245). The anti-r-SAK antibody levels in the r-SAK group decreased with time, but remained significantly higher than those in the NS group on day 90 (±7 days) (2.96 ± 0.68 vs. 0.22 ± 0.53, P < 0.001), day 180 (±7 days) (2.19 ± 0.74 vs. 0.44 ± 0.65, P < 0.001), and day 360 (±14 days) (1.73 ± 0.97 vs. 0.37 ± 0.71, P < 0.001). The in vitro anti-r-SAK antibody neutralization experiments demonstrated that the thrombolysis rate decreased exponentially as the antibody titer increased from 1.90 to 2.20 (67.80% ± 14.19% vs. 44.32% ± 21.54%, P < 0.0001). Therefore, for STEMI patients who are expected to undergo PCI within 120 min, a single bolus of half-dose r-SAK before primary PCI may reduce the one-year MACE risk. The anti-r-SAK antibody persists over one year, and a second r-SAK thrombolysis may not be indicated until at least one year after the first administration, if necessary.
Keywords：recombinant staphylokinasemyocardial infarctionthrombolysispercutaneous coronary intervention
Publication Date：2025-11-30
Online Publishing Date：2026-01-15(First online date of this platform, not the publication date of the document)
Pages：12( 611-621,中插14-中插21 )