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

Author:

Chen Pengsheng12,Eikelboom John W.3ORCID,Tan Chunyue1,Zhang Wenhao1ORCID,Xu Yi4ORCID,Bai Jianling5,Wang Jun4,Wang Tong16,Gong Xiaoxuan1ORCID,Liu Kun17,Chen Xin8,Wang Xiaoyan9,Zhu Li10ORCID,Zhao Xin11,Yang Naiquan12,Jiang Jun13ORCID,Pu Jun14ORCID,Zhao Bo7,Chen Zengguang8ORCID,Li Baihong9,Wang Guoyu10ORCID,Lu Chuan11ORCID,Ying Lianghong12ORCID,Jiang Meng14ORCID,Zhu Xiaomei4ORCID,Ma Jiazheng1ORCID,Dong Zhou1,Li Chen1ORCID,Zong Jiaxin1,Zhang Fumin1,Zhu Jun15,Huang Jun1,Kong Xiangqing1ORCID,Yu Hao5,Li Chunjian1ORCID,

Affiliation:

1. Departments 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.

2. Department of Cardiology, Xuzhou Central Hospital, Jiangsu, China (P.C.).

3. Department of Medicine, McMaster University or Thrombosis Service, Hamilton General Hospital, ON, Canada (J.W.E.).

4. Radiology (Y.X., J.W., X. Zhu), the First Affiliated Hospital of Nanjing Medical University, China.

5. Department of Biostatistics, Nanjing Medical University, Jiangsu, China (J.B., H.Y.).

6. Department of Cardiology, the First People’s Hospital of Yancheng, Jiangsu, China (T.W.).

7. Department of Cardiology, the First People’s Hospital of Lianyungang, Jiangsu, China (K.L., B.Z.).

8. Department of Cardiology, the Affiliated Changzhou No. 2 People’s Hospital of Nanjing Medical University, Jiangsu, China (X.C., Z.C.).

9. Department of Cardiology, Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China (X.W., B.L.).

10. Department of Cardiology, Taizhou People’s Hospital, Jiangsu, China (L.Z., G.W.).

11. Department of Cardiology, the Second Hospital of Dalian Medical University, Liaoning, China (X. Zhao, C. Lu).

12. Department of Cardiology, Huai’an Second People’s Hospital Affiliated to Xuzhou Medical University, Jiangsu, China (N.Y., L.Y.).

13. Department of Cardiology, The Second Affiliated Hospital, Zhejiang University School of Medicine, China (J.J.).

14. Department of Cardiology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, China (J.P., M.J.).

15. Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Beijing, China (J. Zhu).

Abstract

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.

Publisher

Ovid Technologies (Wolters Kluwer Health)

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