Michael Barbella, Managing Editor10.03.22
ZOLL Medical Corporation's AMIHOT III post-approval trial is officially underway.
The first patient has been enrolled in the trial evaluating TherOx SuperSaturated Oxygen (SSO2) Therapy for treating the most severe heart attacks—left anterior descending (LAD) ST-Elevation Myocardial Infarction (STEMI). The patient, treated at WakeMed Health & Hospitals in North Carolina, received SSO2 Therapy, the first U.s. Food and Drug Administration-approved therapy shown to significantly reduce the size of damaged tissue (infarct) following percutaneous coronary intervention (PCI).
“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,” said Frances Wood, M.D., interventional cardiologist at WakeMed. “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.”5
AMIHOT III is a randomized, post-approval evaluation that will further validate the benefits of SSO2 Therapy over current standard of care alone and provide insight into the mechanisms that lead to improved outcomes for LAD STEMI patients. Besides demonstrating the safety and effectiveness of SSO2 Therapy, additional endpoints include incidence of microvascular obstruction (MVO), and outcomes measures such as heart failure readmissions and quality-of-life measures. The study will randomize 434 patients across sites in the United States and Europe. The study’s principal investigator is James Blankenship, M.D., MHCM, MSCAI (University of New Mexico, Albuquerque, NM).
Multiple clinical trials have demonstrated the efficacy of SSO2 Therapy in reducing infarct size in LAD STEMI1,2,3 by delivering a high concentration of dissolved oxygen (seven–10x normal) directly to damaged heart muscle immediately after stenting. TherOx SSO2 Therapy is currently indicated for patients who suffer LAD STEMI—heart attacks with a high mortality rate—treated within six hours of symptom onset. SSO2 Therapy has been shown to reduce relative infarct size—damage to the heart muscle—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.4
“With SSO2 Therapy, ZOLL is expanding care for LAD STEMI patients,” ZOLL Circulation President Christopher Barnabas added. “Previous data serve as a strong indication that we will observe short- and long-term outcome improvements such as reduced incidence of heart failure and mortality in these high-risk patients.”1,2,3,4
ZOLL, an Asahi Kasei company, develops and markets medical devices and software solutions. With products for defibrillation and cardiac monitoring, circulation enhancement and CPR feedback, supersaturated oxygen therapy, data management, ventilation, therapeutic temperature management, and sleep apnea diagnosis and treatment, ZOLL provides a set of technologies that help improve patient outcomes in critical cardiopulmonary conditions.
The Asahi Kasei Group was formed in 1922 with ammonia and cellulose fiber business, With more than 46,000 employees around the world, the company provides solutions through its three business sectors: Material, Homes, and Health Care. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents.
References
1 Stone GW, et al. Circ Cardiovasc Intervent 2009;2:366-75
2 O’Neill WW, et al. Jour of Am Coll Cardiol. 2007;50: 5:397-405.
3 David SW, et al. Catheter Cardiovasc Interv. 2018;1–9.
4 Chen, et al. Catheter Cardiovasc Interv. 2020;1–7.
5 David SW, et al. Evaluation of intracoronary hyperoxemic oxygen therapy in acute anterior myocardial infarction: The IC-HOT study. Catheter Cardiovasc Interv. 2018;1–9. https://onlinelibrary.wiley.com/doi/abs/10.1002/ccd.27905
The first patient has been enrolled in the trial evaluating TherOx SuperSaturated Oxygen (SSO2) Therapy for treating the most severe heart attacks—left anterior descending (LAD) ST-Elevation Myocardial Infarction (STEMI). The patient, treated at WakeMed Health & Hospitals in North Carolina, received SSO2 Therapy, the first U.s. Food and Drug Administration-approved therapy shown to significantly reduce the size of damaged tissue (infarct) following percutaneous coronary intervention (PCI).
“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,” said Frances Wood, M.D., interventional cardiologist at WakeMed. “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.”5
AMIHOT III is a randomized, post-approval evaluation that will further validate the benefits of SSO2 Therapy over current standard of care alone and provide insight into the mechanisms that lead to improved outcomes for LAD STEMI patients. Besides demonstrating the safety and effectiveness of SSO2 Therapy, additional endpoints include incidence of microvascular obstruction (MVO), and outcomes measures such as heart failure readmissions and quality-of-life measures. The study will randomize 434 patients across sites in the United States and Europe. The study’s principal investigator is James Blankenship, M.D., MHCM, MSCAI (University of New Mexico, Albuquerque, NM).
Multiple clinical trials have demonstrated the efficacy of SSO2 Therapy in reducing infarct size in LAD STEMI1,2,3 by delivering a high concentration of dissolved oxygen (seven–10x normal) directly to damaged heart muscle immediately after stenting. TherOx SSO2 Therapy is currently indicated for patients who suffer LAD STEMI—heart attacks with a high mortality rate—treated within six hours of symptom onset. SSO2 Therapy has been shown to reduce relative infarct size—damage to the heart muscle—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.4
“With SSO2 Therapy, ZOLL is expanding care for LAD STEMI patients,” ZOLL Circulation President Christopher Barnabas added. “Previous data serve as a strong indication that we will observe short- and long-term outcome improvements such as reduced incidence of heart failure and mortality in these high-risk patients.”1,2,3,4
ZOLL, an Asahi Kasei company, develops and markets medical devices and software solutions. With products for defibrillation and cardiac monitoring, circulation enhancement and CPR feedback, supersaturated oxygen therapy, data management, ventilation, therapeutic temperature management, and sleep apnea diagnosis and treatment, ZOLL provides a set of technologies that help improve patient outcomes in critical cardiopulmonary conditions.
The Asahi Kasei Group was formed in 1922 with ammonia and cellulose fiber business, With more than 46,000 employees around the world, the company provides solutions through its three business sectors: Material, Homes, and Health Care. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents.
References
1 Stone GW, et al. Circ Cardiovasc Intervent 2009;2:366-75
2 O’Neill WW, et al. Jour of Am Coll Cardiol. 2007;50: 5:397-405.
3 David SW, et al. Catheter Cardiovasc Interv. 2018;1–9.
4 Chen, et al. Catheter Cardiovasc Interv. 2020;1–7.
5 David SW, et al. Evaluation of intracoronary hyperoxemic oxygen therapy in acute anterior myocardial infarction: The IC-HOT study. Catheter Cardiovasc Interv. 2018;1–9. https://onlinelibrary.wiley.com/doi/abs/10.1002/ccd.27905
