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CLINICAL RESEARCH: CLINICAL TRIALS

Acute Myocardial Infarction With Hyperoxemic Therapy (AMIHOT)

A Prospective, Randomized Trial of Intracoronary Hyperoxemic Reperfusion After Percutaneous Coronary Intervention

William W. O'Neill, MD^_*,_*, Jack L. Martin, MD, Simon R. Dixon, MBChB, Antonio L. Bartorelli, MD, Daniela Trabattoni, MD, Pranobe V. Oemrawsingh, MD^||, Douwe E. Atsma, MD^||, Michael Chang, MD^¶, William Marquardt, MD^¶, Jae K. Oh, MD^#, Mitchell W. Krucoff, MD^_**, Raymond J. Gibbons, MD^#, J. Richard Spears, MD AMIHOT Investigators

^_* University of Miami, Miami, Florida
Sharpe-Strumia Research Foundation of the Bryn Mawr Hospital, Main Line Health System, Bryn Mawr, Pennsylvania
William Beaumont Hospital, Royal Oak, Michigan
Centro Cardiologico Monzino, University of Milan, Milan, Italy
^|| Leiden University Medical Center, Leiden, the Netherlands
^¶ Mercy General Hospital, Sacramento, California
^# Mayo Clinic, Rochester, Minnesota
^_** Duke Clinical Research Institute, Durham, North Carolina
Wayne State University, Detroit, Michigan

Manuscript received December 22, 2005; revised manuscript received December 22, 2006, accepted January 2, 2007.

^_* Reprint requests and correspondence: Dr. William W. O'Neill, Leonard M. Miller School of Medicine, University of Miami, P.O. Box 016099 (R.699), Miami, Florida 33101. (Email: woneill{at}med.miami.edu).

Objectives: This study sought to determine whether hyperoxemic reperfusion with aqueous oxygen (AO) improves recovery of ventricular function after percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI).

Background: Hyperbaric oxygen reduces myocardial injury and improves ventricular function when administered during ischemia-reperfusion.

Methods: In a prospective, multicenter study, 269 patients with acute anterior or large inferior AMI undergoing primary or rescue PCI (<24 h from symptom onset) were randomly assigned after successful PCI to receive hyperoxemic reperfusion (treatment group) or normoxemic blood autoreperfusion (control group). Hyperoxemic reperfusion was performed for 90 min using intracoronary AO. The primary end points were final infarct size at 14 days, ST-segment resolution, and regional wall motion score index of the infarct zone at 3 months.

Results: At 30 days, the incidence of major adverse cardiac events was similar between the control and AO groups (5.2% vs. 6.7%, p = 0.62). There was no significant difference in the incidence of the primary end points between the study groups. In post-hoc analysis, anterior AMI patients reperfused <6 h who were treated with AO had a greater improvement in regional wall motion ( wall motion score index = 0.54 in control group vs. 0.75 in AO group, p = 0.03), smaller infarct size (23% of left ventricle in control group vs. 9% of left ventricle in AO group, p = 0.04), and improved ST-segment resolution compared with normoxemic controls.

Conclusions: Intracoronary hyperoxemic reperfusion was safe and well tolerated after PCI for AMI, but did not improve regional wall motion, ST-segment resolution, or final infarct size. A possible treatment effect was observed in anterior AMI patients reperfused <6 h of symptom onset.

Abbreviations and Acronyms   AMI = acute myocardial infarction   AO = aqueous oxygen   PCI = percutaneous coronary intervention   RWMSI = regional wall motion score index   TIMI = Thrombolysis In Myocardial Infarction

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