Pengsheng Chen, John W Eikelboom, Chunyue Tan, Wenhao Zhang, Yi Xu, Jianling Bai, Jun Wang, Tong Wang, Xiaoxuan Gong, Kun Liu, Xin Chen, Xiaoyan Wang, Li Zhu, Xin Zhao, Naiquan Yang, Jun Jiang, Jun Pu, Bo Zhao, Zengguang Chen, Baihong Li, Guoyu Wang, Chuan Lu, Lianghong Ying, Meng Jiang, Xiaomei Zhu, Jiazheng Ma, Zhou Dong, Chen Li, Jiaxin Zong, Fumin Zhang, Jun Zhu, Jun Huang, Xiangqing Kong, Hao Yu, Chunjian Li
{"title":"治疗 ST 段抬高型心肌梗死的初级 PCI 前单次注射 r-SAK","authors":"Pengsheng Chen, John W Eikelboom, Chunyue Tan, Wenhao Zhang, Yi Xu, Jianling Bai, Jun Wang, Tong Wang, Xiaoxuan Gong, Kun Liu, Xin Chen, Xiaoyan Wang, Li Zhu, Xin Zhao, Naiquan Yang, Jun Jiang, Jun Pu, Bo Zhao, Zengguang Chen, Baihong Li, Guoyu Wang, Chuan Lu, Lianghong Ying, Meng Jiang, Xiaomei Zhu, Jiazheng Ma, Zhou Dong, Chen Li, Jiaxin Zong, Fumin Zhang, Jun Zhu, Jun Huang, Xiangqing Kong, Hao Yu, Chunjian Li","doi":"10.1161/CIRCINTERVENTIONS.123.013455","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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%; <i>P</i><0.001) and Thrombolysis in Myocardial Infarction flow grade 3 (51.0% versus 18.0%; <i>P</i><0.001) and had smaller infarct size (21.91±10.84% versus 26.85±12.37%; <i>P</i>=0.016). There was no increase in major bleeding (r-SAK, 1.0% versus control, 3.0%; <i>P</i>=0.616).</p><p><strong>Conclusions: </strong>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.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT05023681.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":6.1000,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Single Bolus r-SAK Before Primary PCI for ST-Segment-Elevation Myocardial Infarction.\",\"authors\":\"Pengsheng Chen, John W Eikelboom, Chunyue Tan, Wenhao Zhang, Yi Xu, Jianling Bai, Jun Wang, Tong Wang, Xiaoxuan Gong, Kun Liu, Xin Chen, Xiaoyan Wang, Li Zhu, Xin Zhao, Naiquan Yang, Jun Jiang, Jun Pu, Bo Zhao, Zengguang Chen, Baihong Li, Guoyu Wang, Chuan Lu, Lianghong Ying, Meng Jiang, Xiaomei Zhu, Jiazheng Ma, Zhou Dong, Chen Li, Jiaxin Zong, Fumin Zhang, Jun Zhu, Jun Huang, Xiangqing Kong, Hao Yu, Chunjian Li\",\"doi\":\"10.1161/CIRCINTERVENTIONS.123.013455\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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%; <i>P</i><0.001) and Thrombolysis in Myocardial Infarction flow grade 3 (51.0% versus 18.0%; <i>P</i><0.001) and had smaller infarct size (21.91±10.84% versus 26.85±12.37%; <i>P</i>=0.016). There was no increase in major bleeding (r-SAK, 1.0% versus control, 3.0%; <i>P</i>=0.616).</p><p><strong>Conclusions: </strong>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.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT05023681.</p>\",\"PeriodicalId\":10330,\"journal\":{\"name\":\"Circulation: Cardiovascular Interventions\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":6.1000,\"publicationDate\":\"2024-02-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Circulation: Cardiovascular Interventions\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1161/CIRCINTERVENTIONS.123.013455\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/1/23 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Circulation: Cardiovascular Interventions","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1161/CIRCINTERVENTIONS.123.013455","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/1/23 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
Single Bolus r-SAK Before Primary PCI for ST-Segment-Elevation Myocardial Infarction.
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.
期刊介绍：
Circulation: Cardiovascular Interventions, an American Heart Association journal, focuses on interventional techniques pertaining to coronary artery disease, structural heart disease, and vascular disease, with priority placed on original research and on randomized trials and large registry studies. In addition, pharmacological, diagnostic, and pathophysiological aspects of interventional cardiology are given special attention in this online-only journal.
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