One-year outcomes of supersaturated oxygen therapy in acute anterior myocardial infarction: The IC-HOT study

Abstract

Background: Supersaturated oxygen (SSO2 ) has recently been approved by the U.S. Food and Drug Administration for administration after primary percutaneous coronary intervention (pPCI) in patients with anterior ST-segment elevation myocardial infarction (STEMI) based on its demonstration of infarct size reduction in the IC-HOT study.

Objectives: To describe the 1-year clinical outcomes of intracoronary SSO2 treatment after pPCI in patients with anterior STEMI.

Methods: IC-HOT was a prospective, open-label, single-arm study in which 100 patients without cardiogenic shock undergoing successful pPCI of an occluded left anterior descending coronary artery were treated with a 60-min SSO2 infusion. One-year clinical outcomes were compared with a propensity-matched control group of similar patients with anterior STEMI enrolled in the INFUSE-AMI trial.

Results: Baseline and postprocedural characteristics were similar in the two groups except for pre-PCI thrombolysis in myocardial infarction 3 flow, which was less prevalent in patients treated with SSO2 (9.6% vs. 22.9%, p = .02). Treatment with SSO2 was associated with a lower 1-year rate of the composite endpoint of all-cause death or new-onset heart failure (HF) or hospitalization for HF (0.0% vs. 12.3%, p = .001). All-cause mortality, driven by cardiovascular mortality, and new-onset HF or HF hospitalization were each individually lower in SSO2 -treated patients. There were no significant differences between groups in the 1-year rates of reinfarction or clinically driven target vessel revascularization.

Conclusions: Infusion of SSO2 following pPCI in patients with anterior STEMI was associated with improved 1-year clinical outcomes including lower rates of death and new-onset HF or HF hospitalizations.

Trial registration: ClinicalTrials.gov NCT02603835.

Keywords: acute myocardial infarction; infarct size; primary percutaneous coronary intervention; supersaturated oxygen.

Conflict of interest statement

D. C. M.: Symposium honoraria—Abbott Vascular, Boston Scientific. A. S. L.: Research grant—Boston Scientific. T. A. L.: research support from Medtronic and Abiomed; speaker honorarium from Novartis and AstraZeneca. P. G.: Speaker's fees—Abbott Vascular, Edwards Lifesciences, Medtronic, Tryton Medical Inc., Cardinal Health, and Cardiovascular Systems Inc., consulting fees—Abbott Vascular, Boston Scientific, Cardiovascular Systems Inc., and Pi‐Cardia; institutional research grant—Boston Scientific. Equity—SIG.NUM, SoundBite Medical Solutions Inc., Saranas, and Pi‐Cardia. A. M.: Grant support from Abbott Vascular and Boston Scientific, consultant for Conavi Medical Inc. G. W. S: Consultant to TherOx, Miracor, and Abiomed. Other authors: No relevant conflicts.

© 2020 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Figures

FIGURE 1

Kaplan–Meier time to first event rates in patients with anterior ST‐segment elevation myocardial infarction according to treatment with SSO2. (a) All‐cause death; (b) new‐onset heart failure (HF) or HF hospitalization; and (c) death, new‐onset HF, or HF hospitalization. SSO2, supersaturated oxygen [Color figure can be viewed at wileyonlinelibrary.com]