One-year outcomes of a single bolus r-SAK before primary PCI for STEMI:Follow-up of the OPTIMA-5 study
Chen Li1
Jie Yu1
Tian Wu1
Qingxia Lin1
Rui Hua1
Zihang Zhong2
Yule Li3
Kun Liu4
Li Zhu5
Naiquan Yang6
Xin Chen7
Xiaoyan Wang8
Xin Zhao9
Jun Jiang10
Bo Zhao4
Xiwen Zhang11
Pengsheng Chen12
Tong Wang13
Yi Xu14
Gaoyong Liao15
Liang Yuan1
Bo Chen1
Zhihui Xu1
Xiaoxuan Gong1
Wenhao Zhang1
Chunyue Tan1
Lei Xu1
Qiang Huang1
Jianling Bai2
John W.Eikelboom16
Chunjian Li1
1.Department of Cardiology,the First Affiliated Hospital of Nanjing Medical University,Nanjing,Jiangsu 210029,China2.Department of Biostatistics,School of Public Health,Nanjing Medical University,Nanjing,Jiangsu 211166,China3.College of Letters and Science,University of Wisconsin-Madison,Madison,WI 53715-1007,USA4.Department of Cardiology,the First People's Hospital of Lianyungang,Lianyungang,Jiangsu 222002,China5.Department of Cardiology,Taizhou People's Hospital,Taizhou,Jiangsu 225300,China6.Department of Cardiology,Huai'an Second People's Hospital Affiliated to Xuzhou Medical University,Huai'an,Jiangsu 223200,China7.Department of Cardiology,the Affiliated Changzhou No.2 People's Hospital of Nanjing Medical University,Changzhou,Jiangsu 213164,China8.Department of Cardiology,Affiliated Hospital of Jiangnan University,Wuxi,Jiangsu 214000,China9.Department of Cardiology,the Second Hospital of Dalian Medical University,Dalian,Liaoning 116027,China10.Department of Cardiology,the Second Affiliated Hospital of Zhejiang University School of Medicine,Hangzhou,Zhejiang 310009,China11.Department of Cardiology,the Affiliated Huai'an No.1 People's Hospital of Nanjing Medical University,Huai'an,Jiangsu 223300,China12.Department of Cardiology,Xuzhou Central Hospital,Xuzhou,Jiangsu 221000,China13.Department of Cardiology,Yancheng No.1 People's Hospital,Yancheng,Jiangsu 224000,China14.Department of Radiology,the First Affiliated Hospital of Nanjing Medical University,Nanjing,Jiangsu 210029,China15.Xintrum Pharmaceuticals Co.,Ltd.,Nanjing,Jiangsu 211100,China16.Department of Medicine,McMaster University or Thrombosis Service,Hamilton General Hospital,Hamilton,Ontario L8S 4L8,Canada
摘要：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<0.000 1).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.
机标关键词：stemisinglestudybolusbeforefollow-upone-yearoptima-5
分类号：R542.22(心脏、血管（循环系）疾病)
论文发表日期：2025-11-30
在线出版日期：2026-01-15（本平台首次上网日期，不代表文献的发表时间）
页数：12( 611-621,中插14-中插21 )
英文信息