Zoll has announced that the first patient has been enrolled in the REAL SSO2 post-market observational study to assess the clinical utility and cost-effectiveness of TherOx SuperSaturated Oxygen (SSO2) therapy compared to percutaneous coronary intervention (PCI) alone in standard of care treatment for ST-elevation myocardial infarction (STEMI) patients.
The first patient was enrolled by the interventional cardiology team at St Mary’s Medical Center in Huntington, USA, led by site investigator Mehiar El-Hamdani and study coordinator Cheryl Kane.
SSO2 therapy is used immediately after stenting is performed for left-anterior descending (LAD) STEMI and within six hours of symptom onset. SSO2 delivers high levels of dissolved oxygen directly to the heart to recover damaged tissue. Data have shown that SSO2 Therapy is associated with lower rates of heart failure and death within one year, and it is the only therapy approved by the US Food and Drug Administration (FDA) to reduce infarct size, Zoll said in a press release.
The REAL SSO2 study is a prospective, real-world multicentre, post-market observational study enrolling 750 patients, including both SSO2-treated and control subjects. The study is intended to further demonstrate the clinical and economic value of SSO2 therapy and evaluate post-event interventions, rehospitalisation, and quality of life measures. The real-world data will be collected from the site enrolments in addition to case data from the American College of Cardiology (ACC) CathPCI patient registry.
“SSO2 therapy is the newest treatment modality in improving care for STEMI patients, and we are thrilled to be leading this study aimed at demonstrating value beyond the acute clinical benefits,” said Robert Yeh, co-principal investigator and interventional cardiologist at Beth Israel Deaconess Medical Center (Boston, USA). “Given the significant reduction in infarct size already demonstrated through previous clinical studies, we expect to see longer-term improvements in this patient population as compared to primary PCI alone.”
In addition to Yeh, the study’s co-principal investigator is David Cohen, director of clinical outcomes & research at Cardiovascular Research Foundation (CRF, New York, USA).
“The REAL SSO2 study is an important step towards positioning SSO2 therapy as a standard of care,” said Christopher Barnabas, president of Zoll Circulation. “Zoll is pleased to partner with top institutions and the ACC on this research, and we believe the study outcomes will further demonstrate the positive impact SSO2 Therapy can have for patients who suffer severe heart attacks.”