Zoll Medical Begins AMIHOT III Postapproval Study of TherOx Therapy for LAD STEMI Patients

September 7, 2022—Zoll Medical Corporation, an Asahi Kasei company, announced that the first patient has been enrolled in the AMIHOT III postapproval study of the company’s TherOx supersaturated oxygen (SSO₂) therapy for the treatment of left anterior descending (LAD) ST-segment elevation myocardial infarction (STEMI). TherOx SSO₂ therapy is currently indicated for patients with LAD STEMI treated within 6 hours of symptom onset.

According to the company, the FDA-approved TherOx SSO₂ therapy has been shown to significantly reduce the size of infarct after percutaneous coronary intervention.

The randomized AMIHOT III study will further validate the benefits of SSO₂ therapy compared with current standard of care alone and provide insight into the mechanisms that lead to improved outcomes for LAD STEMI patients.

In addition to demonstrating the safety and effectiveness of SSO₂ therapy, other endpoints include the incidence of microvascular obstruction and outcomes measures such as heart failure readmissions and quality-of-life measures.

The AMIHOT III study will randomize 434 patients at sites in the United States and Europe. The study’s Principal Investigator is James Blankenship, MD, of the University of New Mexico in Albuquerque, New Mexico.

The first patient enrolled in the postapproval study was treated with Therox SSO₂ therapy at WakeMed Health & Hospitals in Raleigh, North Carolina.

Frances Wood, MD, interventional cardiologist at WakeMed, commented in the company’s press release, “WakeMed strives to be on the cutting edge of cardiovascular care, and I am excited that our team has enrolled the first AMIHOT III patient in this study to further confirm SSO₂ therapy’s benefits over standard of care in the treatment of severe heart attacks. Based on our experience with the IC-HOT trial that helped SSO₂ achieve FDA approval, we believe this therapy will have a strong impact in improving outcomes and reducing mortality for heart attack patients.”

Zoll Medical noted that SSO₂ therapy has been shown to reduce relative infarct size by 26% over standard of care. One-year follow-up data on patients treated with SSO₂ therapy showed reductions in heart failure hospitalization and mortality. Multiple clinical trials have demonstrated the efficacy of SSO₂ therapy in reducing infarct size in LAD STEMI by delivering a high concentration of dissolved oxygen (7 to 10x normal) directly to damaged heart muscle immediately after stenting.