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

被引:3
作者
Chen, Pengsheng [1 ,3 ]
Eikelboom, John W. [4 ]
Tan, Chunyue [1 ]
Zhang, Wenhao [1 ]
Xu, Yi [2 ]
Bai, Jianling [5 ]
Wang, Jun [2 ]
Wang, Tong [1 ,6 ]
Gong, Xiaoxuan [1 ]
Liu, Kun [1 ,7 ]
Chen, Xin [8 ]
Wang, Xiaoyan [9 ]
Zhu, Li [10 ]
Zhao, Xin [11 ]
Yang, Naiquan [12 ]
Jiang, Jun [13 ]
Pu, Jun [14 ]
Zhao, Bo [7 ]
Chen, Zengguang [8 ]
Li, Baihong [9 ]
Wang, Guoyu [10 ]
Lu, Chuan [11 ]
Ying, Lianghong [12 ]
Jiang, Meng [14 ]
Zhu, Xiaomei [2 ]
Ma, Jiazheng [1 ]
Dong, Zhou [1 ]
Li, Chen [1 ]
Zong, Jiaxin [1 ]
Zhang, Fumin [1 ]
Zhu, Jun [15 ]
Huang, Jun [1 ]
Kong, Xiangqing [1 ]
Yu, Hao [5 ]
Li, Chunjian [1 ,16 ]
机构
[1] Nanjing Med Univ, Affiliated Hosp 1, Dept Cardiol, Nanjing, Peoples R China
[2] Nanjing Med Univ, Affiliated Hosp 1, Dept Radiol, Nanjing, Peoples R China
[3] Xuzhou Cent Hosp, Dept Cardiol, Xuzhou, Jiangsu, Peoples R China
[4] McMaster Univ, Hamilton Gen Hosp, Dept Med, Thrombosis Serv, Hamilton, ON, Canada
[5] Nanjing Med Univ, Dept Biostat, Nanjing, Jiangsu, Peoples R China
[6] First Peoples Hosp Yancheng, Dept Cardiol, Yancheng, Jiangsu, Peoples R China
[7] First Peoples Hosp Lianyungang, Dept Cardiol, Lianyungang, Jiangsu, Peoples R China
[8] Nanjing Med Univ, Affiliated Changzhou Peoples Hosp 2, Dept Cardiol, Nanjing, Jiangsu, Peoples R China
[9] Jiangnan Univ, Dept Cardiol, Affiliated Hosp, Wuxi, Jiangsu, Peoples R China
[10] Taizhou Peoples Hosp, Dept Cardiol, Taizhou, Jiangsu, Peoples R China
[11] Dalian Med Univ, Hosp 2, Dept Cardiol, Dalian, Liaoning, Peoples R China
[12] Xuzhou Med Univ, Huaian Peoples Hosp 2, Dept Cardiol, Xuzhou, Jiangsu, Peoples R China
[13] Zhejiang Univ, Affiliated Hosp 2, Dept Cardiol, Sch Med, Hangzhou, Peoples R China
[14] Shanghai Jiao Tong Univ, Renji Hosp, Sch Med, Dept Cardiol, Shanghai, Peoples R China
[15] Fuwai Hosp, Natl Ctr Cardiovasc Dis, Dept Cardiol, Beijing, Peoples R China
[16] Nanjing Med Univ, Affiliated Hosp 1, Dept Cardiol, 300 Guangzhou Rd, Nanjing 210029, Peoples R China
关键词
follow-up studies; myocardial infarction; percutaneous coronary intervention; prospective studies; random allocation; PERCUTANEOUS CORONARY INTERVENTION; TREATED STEMI PATIENTS; PRIMARY ANGIOPLASTY; DOSE ALTEPLASE; FACILITATED PCI; ARTERY PATENCY; PLUS ABCIXIMAB; TRIAL; FIBRINOLYSIS; CLOPIDOGREL;
D O I
10.1161/CIRCINTERVENTIONS.123.013455
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
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页数:12
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