TherOx conducted an FDA-approved Phase I feasibility study of SSO2 Therapy subsequent to PCI and stenting for acute myocardial infarction (AMI). This study demonstrated the promise of SSO2 Therapy in the treatment of AMI and provided a foundation for the AMIHOT I and AMIHOT II studies.
The OYSTER-AMI study was conducted at Centro Cardiologico Monzino in Milan, Italy under the guidance of Dr. Antonio Bartorelli. This study demonstrated the promise of SSO2 Therapy in the treatment of heart attack and provided an additional foundation for the AMIHOT and AMIHOT II trials.
The AMIHOT (Acute Myocardial Infarction with Hyperoxemic Oxygen Therapy) I study was an FDA-sanctioned, multi-center randomized study to evaluate the safety and effectiveness of SSO2 Therapy for the treatment of AMI. 289 subjects were enrolled in the study, including 269 randomized patients and 20 non-randomized run-in patients. Three co-primary surrogate endpoints were evaluated: ST segment resolution measured through total ischemic area under the curve, infarct size at 14 days (using Tc-99m SPECT imaging), and regional wall motion score index (RWMSI) improvement over 3 months.
Results demonstrated comparability in major adverse cardiac events (MACE) at 30 days, but did not show statistically significant improvement in the three surrogate endpoints of myocardial function and recovery in the overall patient population, which included a 24 hour inclusion window for both inferior and anterior wall AMI. However, in a subset of anterior AMI subjects treated within six hours of symptom onset, significant improvements were observed in all three surrogate endpoints. This population formed the basis for the AMIHOT II trial.
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