AMIHOT II Pivotal Trial
The AMIHOT II trial, sponsored by TherOx, was a randomized, international multicenter trial to evaluate the safety and effectiveness of SSO2 Therapy in the treatment of anterior wall AMI treated with PCI and stenting within 6 hours of reported symptom onset. TherOx announced the completion of this FDA-approved trial in October, 2007.
Results from the AMIHOT I and AMIHOT II trials showed a median 26% decrease in infarct size in anterior MI patients treated within 6 hours of symptom onset who received SSO2 Therapy following PCI with stenting, vs. a Control group which received PCI with stenting alone.* 30-day MACE comparison (Major Adverse Cardiac Events, including death, reinfarction, target vessel revascularization, and stroke) demonstrated non-inferiority compared to PCI with stenting alone.**
* Bayesian posterior probability of superiority = 96.9%. Results based on a Bayesian statistical analysis of the AMIHOT I and AMIHOT II clinical studies.
** Bayesian posterior probability of non-inferiority = 99.5% that the SSO2 Therapy group MACE rate is within 6% of the Control group MACE rate.
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