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Hyperoxemic oxygen therapy in patients with acute anterior myocardial infarction: HOT-AAMI-design and rationale of a
Uwe Zeymer1, Fathema Hassinger2, Peter Bramlage2
1Stiftung 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.
Insights
This study investigates if hyperoxemic supersaturated oxygen (SSO2) therapy after percutaneous coronary intervention (PCI) can reduce death and heart failure in patients with ST-elevation myocardial infarction (STEMI). The HOT-AAMI trial is the first to assess this for clinical outcomes.
Area of Science:
- Cardiology
- Interventional Cardiology
- Critical Care Medicine
Background:
- Patients with acute anterior ST-elevation myocardial infarction (STEMI) face high risks of mortality and heart failure (HF) post-primary percutaneous coronary intervention (PCI).
- Previous trials indicated that hyperoxemic supersaturated oxygen (SSO2) therapy post-PCI could reduce infarct size, but lacked power for clinical endpoints.
Purpose of the Study:
- To evaluate the efficacy of hyperoxemic supersaturated oxygen (SSO2) therapy as an adjunct to standard care in reducing death and heart failure events in anterior STEMI patients post-PCI.
- The HOT-AAMI trial is specifically powered to assess the impact of SSO2 on major adverse clinical outcomes.
Main Methods:
- A multicenter, randomized, open-label study (HOT-AAMI) involving 1,266 patients with anterior STEMI undergoing successful PCI.
- Patients were randomized 1:1 to receive either SSO2 therapy plus standard care or standard care alone.
- The primary endpoint is a composite of all-cause mortality or unplanned heart failure hospital admission/outpatient visit requiring diuretics within 12-48 months.
Main Results:
- This section is not available in the provided abstract as the trial is likely ongoing or results are yet to be published.
- The study is designed to detect a 25% relative reduction in the primary composite endpoint with 80% power.
Conclusions:
- The HOT-AAMI trial is the first adequately powered study to ascertain if immediate post-PCI SSO2 therapy improves clinical outcomes (death and heart failure) in anterior STEMI patients.
- Results will clarify the role of SSO2 as an adjunctive therapy in managing acute myocardial infarction.
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 2-sided significance level of 0.05 and 80% power, requiring a total of 393 events; therefore 1,266 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.
Trial Registration:
HOT-AAMI Clinicaltrials.gov NCT06742684.
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