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

follow-up studies myocardial infarction percutaneous coronary intervention prospective studies random allocation

Journal

Circulation. Cardiovascular interventions
ISSN: 1941-7632
Titre abrégé: Circ Cardiovasc Interv
Pays: United States
ID NLM: 101499602

Informations de publication

Date de publication:
23 Jan 2024
Historique:
medline: 23 1 2024
pubmed: 23 1 2024
entrez: 23 1 2024
Statut: aheadofprint

Résumé

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. 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. 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%; 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. URL: https://www.clinicaltrials.gov; Unique identifier: NCT05023681.

Sections du résumé

BACKGROUND UNASSIGNED
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 UNASSIGNED
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 UNASSIGNED
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%;
CONCLUSIONS UNASSIGNED
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 UNASSIGNED
URL: https://www.clinicaltrials.gov; Unique identifier: NCT05023681.

Identifiants

DOI: 10.1161/CIRCINTERVENTIONS.123.013455 PMID: 38258563
pubmed: 38258563
doi: 10.1161/CIRCINTERVENTIONS.123.013455
doi:

Banques de données

ClinicalTrials.gov
['NCT05023681']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

e013455

Investigateurs

Hui Yong (H)
Inam Ullah (I)
Zhiwen Tao (Z)
Zhihui Xu (Z)
Yong Li (Y)
Liang Yuan (L)
Bo Chen (B)
Zhengxian Tao (Z)
Lei Xu (L)
Xinli Li (X)
Zihang Zhong (Z)
Wen Liu (W)
Mingzhu Li (M)
Ying Zhou (Y)
Yuan Ji (Y)
Yi Ma (Y)
Jianbo Xiang (J)
Xihui Wang (X)
Jingjing Shi (J)
Hongyan Qiao (H)
Ruzhu Wang (R)
Jian Zhang (J)
Ji Zhang (J)
Yu Wang (Y)
Xiaofeng Qu (X)
Yuanyuan Sang (Y)
Xiaoyu Chen (X)
Yabin Liu (Y)

Auteurs

Pengsheng Chen (P)

Department of Cardiology, the First Affiliated Hospital of Nanjing Medical University, China. (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).
Department of Cardiology, Xuzhou Central Hospital, Jiangsu, China (P.C.).

John W Eikelboom (JW)

Department of Medicine, McMaster University or Thrombosis Service, Hamilton General Hospital, ON, Canada (J.W.E.).
ORCID: 0000-0003-4126-1285

Chunyue Tan (C)

Department of Cardiology, the First Affiliated Hospital of Nanjing Medical University, China. (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).

Wenhao Zhang (W)

Department of Cardiology, the First Affiliated Hospital of Nanjing Medical University, China. (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).
ORCID: 0000-0002-4491-0554

Yi Xu (Y)

Department of Radiology, the First Affiliated Hospital of Nanjing Medical University, China. (Y.X., J.W., X. Zhu).
ORCID: 0000-0003-1235-3068

Jianling Bai (J)

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

Jun Wang (J)

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

Tong Wang (T)

Department of Cardiology, the First Affiliated Hospital of Nanjing Medical University, China. (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).
Department of Cardiology, the First People's Hospital of Yancheng, Jiangsu, China (T.W.).

Xiaoxuan Gong (X)

Department of Cardiology, the First Affiliated Hospital of Nanjing Medical University, China. (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).
ORCID: 0000-0003-3007-0387

Kun Liu (K)

Department of Cardiology, the First Affiliated Hospital of Nanjing Medical University, China. (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).
Department of Cardiology, the First People's Hospital of Lianyungang, Jiangsu, China (K.L., B.Z.).

Xin Chen (X)

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

Xiaoyan Wang (X)

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

Li Zhu (L)

Department of Cardiology, Taizhou People's Hospital, Jiangsu, China (L.Z., G.W.).
ORCID: 0000-0002-6804-5235

Xin Zhao (X)

Department of Radiology, the First Affiliated Hospital of Nanjing Medical University, China. (Y.X., J.W., X. Zhu).
Department of Cardiology, the Second Hospital of Dalian Medical University, Liaoning, China (X. Zhao, C. Lu).

Naiquan Yang (N)

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

Jun Jiang (J)

Department of Cardiology, The Second Affiliated Hospital, Zhejiang University School of Medicine, China (J.J.).
ORCID: 0000-0001-6926-9516

Jun Pu (J)

Department of Cardiology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, China (J.P., M.J.).
ORCID: 0000-0003-2240-5108

Bo Zhao (B)

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

Zengguang Chen (Z)

Department of Cardiology, the Affiliated Changzhou No. 2 People's Hospital of Nanjing Medical University, Jiangsu, China (X.C., Z.C.).
ORCID: 0000-0002-0895-3215

Baihong Li (B)

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

Guoyu Wang (G)

Department of Cardiology, Taizhou People's Hospital, Jiangsu, China (L.Z., G.W.).
ORCID: 0000-0003-1343-1187

Chuan Lu (C)

Department of Cardiology, the Second Hospital of Dalian Medical University, Liaoning, China (X. Zhao, C. Lu).
ORCID: 0000-0002-2272-7097

Lianghong Ying (L)

Department of Cardiology, Huai'an Second People's Hospital Affiliated to Xuzhou Medical University, Jiangsu, China (N.Y., L.Y.).
ORCID: 0000-0001-5676-5385

Meng Jiang (M)

Department of Cardiology, the First Affiliated Hospital of Nanjing Medical University, China. (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).
ORCID: 0000-0003-3180-8419

Xiaomei Zhu (X)

Department of Cardiology, the First Affiliated Hospital of Nanjing Medical University, China. (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).
ORCID: 0000-0002-7591-9930

Jiazheng Ma (J)

Department of Cardiology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, China (J.P., M.J.).
ORCID: 0000-0002-3534-604X

Zhou Dong (Z)

Department of Cardiology, the First Affiliated Hospital of Nanjing Medical University, China. (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).

Chen Li (C)

Department of Cardiology, the First Affiliated Hospital of Nanjing Medical University, China. (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).
ORCID: 0000-0002-0070-9912

Jiaxin Zong (J)

Department of Cardiology, the First Affiliated Hospital of Nanjing Medical University, China. (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).

Fumin Zhang (F)

Department of Cardiology, the First Affiliated Hospital of Nanjing Medical University, China. (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).

Jun Zhu (J)

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

Jun Huang (J)

Department of Cardiology, the First Affiliated Hospital of Nanjing Medical University, China. (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).

Xiangqing Kong (X)

Department of Cardiology, the First Affiliated Hospital of Nanjing Medical University, China. (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).
ORCID: 0000-0003-3309-1140

Hao Yu (H)

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

Chunjian Li (C)

Department of Cardiology, the First Affiliated Hospital of Nanjing Medical University, China. (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).
ORCID: 0000-0002-2359-7570

Classifications MeSH