Kevin R. Bainey MD, MSc , Robert C. Welsh MD , Yinggan Zheng MA, MEd , Alexandra Arias-Mendoza MD , Arsen D. Ristić MD, PhD , Oleg V. Averkov MD, PhD , Yves Lambert MD , Tracy Temple BScN, RN , Eric Ly BHK , Kris Bogaerts PhD , Peter Sinnaeve MD, PhD , Cynthia M. Westerhout PhD , Frans Van de Werf MD, PhD , Paul W. Armstrong MD , STREAM-2 Investigators
{"title":"Pharmaco-invasive strategy and dosing of tenecteplase in STEMI patients 60 to <75 years: An inter-trial comparison of the STREAM-1 and STREAM-2 trials","authors":"Kevin R. Bainey MD, MSc , Robert C. Welsh MD , Yinggan Zheng MA, MEd , Alexandra Arias-Mendoza MD , Arsen D. Ristić MD, PhD , Oleg V. Averkov MD, PhD , Yves Lambert MD , Tracy Temple BScN, RN , Eric Ly BHK , Kris Bogaerts PhD , Peter Sinnaeve MD, PhD , Cynthia M. Westerhout PhD , Frans Van de Werf MD, PhD , Paul W. Armstrong MD , STREAM-2 Investigators","doi":"10.1016/j.ahj.2025.02.002","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Previous studies indicate a safety risk with full-dose TNK in elderly patients. In a study of patients ≥60 years STREAM-2 (STrategic Reperfusion Early After Myocardial infarction-2), a pharmaco-invasive (PI) strategy with half-dose TNK was similar (in efficacy and safety) to primary percutaneous coronary intervention (PPCI) in ST-elevation myocardial infarction (STEMI) patients presenting <3 hours. While no treatment difference ± 75 years was observed, the role of this half-dose PI strategy in patients <75 years is unknown. In this comparison of STEAM-1 and -2, we analyzed PI strategies with full-dose (STREAM-1) versus half-dose TNK (STREAM-2) to evaluate their relative efficacy and safety in this younger STEMI cohort.</div></div><div><h3>Methods</h3><div>We evaluated patients 60 to <75 years from STREAM-1 and STREAM-2 receiving PI treatment versus PPCI for their resolution of ST-elevation after fibrinolysis and angiography, primary efficacy composite of 30-day all-cause death, myocardial infarction, heart failure, and shock, and safety events.</div></div><div><h3>Results</h3><div>Among 1103 patients, 327 received a full-dose PI strategy (STREAM-1), 289 a half-dose PI strategy (STREAM-2) and 487 PPCI (338 in STREAM-1; 149 in STREAM-2). Half- compared to full-dose TNK resulted in similar proportions of patients achieving ST resolution ≥50% (71.2% vs 68.7%, <em>P = .</em>519): their ICH risks were 2.1% vs 1.5%, <em>P = .</em>605 respectively). Following angiography, PI patients had nominally better ST resolution ≥50% compared to their PPCI counterpart (STREAM-1: 87.7% vs. 83.2%, <em>P = .</em>120; STREAM-2: 88.2% vs. 81.0%, <em>P = .</em>048) with similar primary composite outcome at 30 days (STREAM-1: 14.4% vs. 16.3%, 0.90 [0.62, 1.31]; STREAM-2: 9.0% vs 8.1%, 1.29 [0.64, 2.61]). Major (non-ICH) bleeding markedly declined in STREAM-2 compared to STREAM-1 in both treatment groups (STREAM-1: 7.1% vs. 6.0%; STREAM-2: 0.3% vs. 0.7%).</div></div><div><h3>Conclusions</h3><div>In STEMI patients 60 to <75 years presenting within 3 hours of symptoms, half-dose PI treatment appears as efficacious as a full-dose PI strategy with a low systemic bleeding risk. Half-dose PI treatment deserves consideration when timely PPCI is not attainable in this important STEMI sub-group.</div></div><div><h3>Clinicaltrials.gov registration numbers</h3><div>NCT00623623, NCT02777580.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"284 ","pages":"Pages 20-31"},"PeriodicalIF":3.7000,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"American heart journal","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0002870325000328","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
Abstract
Background
Previous studies indicate a safety risk with full-dose TNK in elderly patients. In a study of patients ≥60 years STREAM-2 (STrategic Reperfusion Early After Myocardial infarction-2), a pharmaco-invasive (PI) strategy with half-dose TNK was similar (in efficacy and safety) to primary percutaneous coronary intervention (PPCI) in ST-elevation myocardial infarction (STEMI) patients presenting <3 hours. While no treatment difference ± 75 years was observed, the role of this half-dose PI strategy in patients <75 years is unknown. In this comparison of STEAM-1 and -2, we analyzed PI strategies with full-dose (STREAM-1) versus half-dose TNK (STREAM-2) to evaluate their relative efficacy and safety in this younger STEMI cohort.
Methods
We evaluated patients 60 to <75 years from STREAM-1 and STREAM-2 receiving PI treatment versus PPCI for their resolution of ST-elevation after fibrinolysis and angiography, primary efficacy composite of 30-day all-cause death, myocardial infarction, heart failure, and shock, and safety events.
Results
Among 1103 patients, 327 received a full-dose PI strategy (STREAM-1), 289 a half-dose PI strategy (STREAM-2) and 487 PPCI (338 in STREAM-1; 149 in STREAM-2). Half- compared to full-dose TNK resulted in similar proportions of patients achieving ST resolution ≥50% (71.2% vs 68.7%, P = .519): their ICH risks were 2.1% vs 1.5%, P = .605 respectively). Following angiography, PI patients had nominally better ST resolution ≥50% compared to their PPCI counterpart (STREAM-1: 87.7% vs. 83.2%, P = .120; STREAM-2: 88.2% vs. 81.0%, P = .048) with similar primary composite outcome at 30 days (STREAM-1: 14.4% vs. 16.3%, 0.90 [0.62, 1.31]; STREAM-2: 9.0% vs 8.1%, 1.29 [0.64, 2.61]). Major (non-ICH) bleeding markedly declined in STREAM-2 compared to STREAM-1 in both treatment groups (STREAM-1: 7.1% vs. 6.0%; STREAM-2: 0.3% vs. 0.7%).
Conclusions
In STEMI patients 60 to <75 years presenting within 3 hours of symptoms, half-dose PI treatment appears as efficacious as a full-dose PI strategy with a low systemic bleeding risk. Half-dose PI treatment deserves consideration when timely PPCI is not attainable in this important STEMI sub-group.
期刊介绍:
The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.