Uwe Zeymer, Fathema Hassinger, Peter Bramlage, Andreas Schäfer, Dirk Westermann, Holger Thiele
{"title":"Hyperoxemic Oxygen Therapy in Patients with Acute Anterior Myocardial Infarction: HOT-AAMI - Design and Rationale of a Randomized Trial.","authors":"Uwe Zeymer, Fathema Hassinger, Peter Bramlage, Andreas Schäfer, Dirk Westermann, Holger Thiele","doi":"10.1016/j.ahj.2025.03.013","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Patients with acute anterior ST-elevation myocardial infarction (STEMI) are at high risk for death and heart failure (HF) despite treatment with primary percutaneous coronary intervention (PCI). Adjunctive therapy with hyperoxemic supersaturated oxygen (SSO2) following PCI reduced infarct size in previous randomized trials, but none of these trials were powered for clinical endpoints.</p><p><strong>Aims: </strong>The HOT-AAMI trial evaluates whether hyperoxemic supersaturated oxygen (SSO2) therapy following PCI reduces the risk of death and heart failure.</p><p><strong>Methods: </strong>HOT-AAMI is a multicenter, 1:1 randomized, open-label study across 50 sites in Germany. Patients presenting with anterior STEMI and undergoing successful PCI of the left anterior descending artery are randomized to receive SSO2 therapy on top of standard care or standard of care alone. The primary endpoint is a composite of all-cause mortality or unplanned heart failure hospital admission or outpatient visit due to heart failure requiring intravenous diuretic therapy during 12-48 months follow-up. Secondary endpoints include cardiovascular mortality, recurrent myocardial infarction, stroke, and quality of life. The sample size calculation for the HOT-AAMI trial is based on detecting a relative reduction of 25% in the primary composite endpoint. In the control group, a yearly event rate of 16% is expected, comprised of mortality (7%), hospitalization for heart failure (5%), and acute heart failure requiring outpatient treatment (4%). The study is designed to detect this 25 % relative difference with a two-sided significance level of 0.05 and 80% power, requiring a total of 393 events; therefore 1266 patients will be enrolled.</p><p><strong>Conclusions: </strong>The HOT-AAMI trial is the first trial powered to determine whether SSO2 therapy, administered immediately post-PCI, improves death and heart failure outcomes in patients with anterior STEMI.</p><p><strong>Trial registration: </strong>HOT-AAMI Clinicaltrials.gov NCT06742684.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":""},"PeriodicalIF":3.7000,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"American heart journal","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.ahj.2025.03.013","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: Patients with acute anterior ST-elevation myocardial infarction (STEMI) are at high risk for death and heart failure (HF) despite treatment with primary percutaneous coronary intervention (PCI). Adjunctive therapy with hyperoxemic supersaturated oxygen (SSO2) following PCI reduced infarct size in previous randomized trials, but none of these trials were powered for clinical endpoints.
Aims: The HOT-AAMI trial evaluates whether hyperoxemic supersaturated oxygen (SSO2) therapy following PCI reduces the risk of death and heart failure.
Methods: HOT-AAMI is a multicenter, 1:1 randomized, open-label study across 50 sites in Germany. Patients presenting with anterior STEMI and undergoing successful PCI of the left anterior descending artery are randomized to receive SSO2 therapy on top of standard care or standard of care alone. The primary endpoint is a composite of all-cause mortality or unplanned heart failure hospital admission or outpatient visit due to heart failure requiring intravenous diuretic therapy during 12-48 months follow-up. Secondary endpoints include cardiovascular mortality, recurrent myocardial infarction, stroke, and quality of life. The sample size calculation for the HOT-AAMI trial is based on detecting a relative reduction of 25% in the primary composite endpoint. In the control group, a yearly event rate of 16% is expected, comprised of mortality (7%), hospitalization for heart failure (5%), and acute heart failure requiring outpatient treatment (4%). The study is designed to detect this 25 % relative difference with a two-sided significance level of 0.05 and 80% power, requiring a total of 393 events; therefore 1266 patients will be enrolled.
Conclusions: The HOT-AAMI trial is the first trial powered to determine whether SSO2 therapy, administered immediately post-PCI, improves death and heart failure outcomes in patients with anterior STEMI.
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.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
