Zeymer Uwe, Hassinger Fathema, Bramlage Peter, Schafer Andreas, Westermann Dirk, Thiele Holger
Stiftung IHF, Department of Cardiology, Institut für Herzinfarktforschung, Ludwigshafen, Germany; Department of Cardiology and Angiology, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg; IHF GmbH - Institut für Herzinfarktforschung, Ludwigshafen, Germany.
IHF GmbH - Institut für Herzinfarktforschung, Ludwigshafen, Germany.
Am Heart J. 2025 Aug;286:35-44. doi: 10.1016/j.ahj.2025.03.013. Epub 2025 Mar 21.
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.
The HOT-AAMI trial evaluates whether hyperoxemic supersaturated oxygen (SSO2) therapy following PCI reduces the risk of death and heart failure.
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 2-sided significance level of 0.05 and 80% power, requiring a total of 393 events; therefore 1,266 patients will be enrolled.
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.
HOT-AAMI Clinicaltrials.gov NCT06742684.
尽管接受了直接经皮冠状动脉介入治疗（PCI），急性前壁ST段抬高型心肌梗死（STEMI）患者仍面临较高的死亡和心力衰竭（HF）风险。在先前的随机试验中，PCI术后采用高氧超饱和氧（SSO2）辅助治疗可缩小梗死面积，但这些试验均未以临床终点为研究目标。
HOT-AAMI试验旨在评估PCI术后高氧超饱和氧（SSO2）治疗是否能降低死亡和心力衰竭风险。
HOT-AAMI是一项在德国50个地点进行的多中心、1:1随机、开放标签研究。出现前壁STEMI并成功对左前降支进行PCI的患者被随机分配，在标准治疗基础上接受SSO2治疗或仅接受标准治疗。主要终点是在12至48个月的随访期间，全因死亡率、因心力衰竭计划外住院或因心力衰竭需要静脉利尿剂治疗的门诊就诊的综合结果。次要终点包括心血管死亡率、再发心肌梗死、中风和生活质量。HOT-AAMI试验的样本量计算基于检测主要复合终点相对降低25%。在对照组中，预计年事件发生率为16%，包括死亡率（7%）、因心力衰竭住院（5%）和需要门诊治疗的急性心力衰竭（4%）。该研究旨在以双侧显著性水平0.05和80%的检验效能检测这25%的相对差异，共需要393个事件；因此将招募1266名患者。
HOT-AAMI试验是首个有足够检验效能来确定PCI术后立即给予SSO2治疗是否能改善前壁STEMI患者死亡和心力衰竭结局的试验。
HOT-AAMI Clinicaltrials.gov NCT06742684。
