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Single Bolus r-SAK Before Primary PCI for ST-Segment-Elevation Myocardial Infarction.
Chen, Pengsheng; Eikelboom, John W; Tan, Chunyue; Zhang, Wenhao; Xu, Yi; Bai, Jianling; Wang, Jun; Wang, Tong; Gong, Xiaoxuan; Liu, Kun; Chen, Xin; Wang, Xiaoyan; Zhu, Li; Zhao, Xin; Yang, Naiquan; Jiang, Jun; Pu, Jun; Zhao, Bo; Chen, Zengguang; Li, Baihong; Wang, Guoyu; Lu, Chuan; Ying, Lianghong; Jiang, Meng; Zhu, Xiaomei; Ma, Jiazheng; Dong, Zhou; Li, Chen; Zong, Jiaxin; Zhang, Fumin; Zhu, Jun; Huang, Jun; Kong, Xiangqing; Yu, Hao; Li, Chunjian.
Afiliação
  • Chen P; 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.
  • Eikelboom JW; Department of Cardiology, Xuzhou Central Hospital, Jiangsu, China (P.C.).
  • Tan C; Department of Medicine, McMaster University or Thrombosis Service, Hamilton General Hospital, ON, Canada (J.W.E.).
  • Zhang W; 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.
  • Xu Y; 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.
  • Bai J; Radiology (Y.X., J.W., X. Zhu), the First Affiliated Hospital of Nanjing Medical University, China.
  • Wang J; Department of Biostatistics, Nanjing Medical University, Jiangsu, China (J.B., H.Y.).
  • Wang T; Radiology (Y.X., J.W., X. Zhu), the First Affiliated Hospital of Nanjing Medical University, China.
  • Gong X; 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.
  • Liu K; Department of Cardiology, the First People's Hospital of Yancheng, Jiangsu, China (T.W.).
  • Chen X; 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.
  • Wang X; 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.
  • Zhu L; Department of Cardiology, the First People's Hospital of Lianyungang, Jiangsu, China (K.L., B.Z.).
  • Zhao X; Department of Cardiology, the Affiliated Changzhou No. 2 People's Hospital of Nanjing Medical University, Jiangsu, China (X.C., Z.C.).
  • Yang N; Department of Cardiology, Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China (X.W., B.L.).
  • Jiang J; Department of Cardiology, Taizhou People's Hospital, Jiangsu, China (L.Z., G.W.).
  • Pu J; Department of Cardiology, the Second Hospital of Dalian Medical University, Liaoning, China (X. Zhao, C. Lu).
  • Zhao B; Department of Cardiology, Huai'an Second People's Hospital Affiliated to Xuzhou Medical University, Jiangsu, China (N.Y., L.Y.).
  • Chen Z; Department of Cardiology, The Second Affiliated Hospital, Zhejiang University School of Medicine, China (J.J.).
  • Li B; Department of Cardiology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, China (J.P., M.J.).
  • Wang G; Department of Cardiology, the First People's Hospital of Lianyungang, Jiangsu, China (K.L., B.Z.).
  • Lu C; Department of Cardiology, the Affiliated Changzhou No. 2 People's Hospital of Nanjing Medical University, Jiangsu, China (X.C., Z.C.).
  • Ying L; Department of Cardiology, Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China (X.W., B.L.).
  • Jiang M; Department of Cardiology, Taizhou People's Hospital, Jiangsu, China (L.Z., G.W.).
  • Zhu X; Department of Cardiology, the Second Hospital of Dalian Medical University, Liaoning, China (X. Zhao, C. Lu).
  • Ma J; Department of Cardiology, Huai'an Second People's Hospital Affiliated to Xuzhou Medical University, Jiangsu, China (N.Y., L.Y.).
  • Dong Z; Department of Cardiology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, China (J.P., M.J.).
  • Li C; Radiology (Y.X., J.W., X. Zhu), the First Affiliated Hospital of Nanjing Medical University, China.
  • Zong J; 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.
  • Zhang F; 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.
  • Zhu J; 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.
  • Huang J; 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.
  • Kong X; 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.
  • Yu H; Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Beijing, China (J. Zhu).
  • Li C; 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.
Circ Cardiovasc Interv ; 17(2): e013455, 2024 02.
Article em En | MEDLINE | ID: mdl-38258563
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.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Metaloendopeptidases / Intervenção Coronária Percutânea / Infarto do Miocárdio com Supradesnível do Segmento ST / Infarto do Miocárdio Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Metaloendopeptidases / Intervenção Coronária Percutânea / Infarto do Miocárdio com Supradesnível do Segmento ST / Infarto do Miocárdio Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2024 Tipo de documento: Article