October 26, 2022 – Abiomed (Nasdaq: ABMD) announced a new program to address health disparities in underserved communities, as new data provides an example of how better access to the Impella heart pump can improve health equity for non-Caucasian cardiovascular patients. Data from a subgroup analysis of 93 non-Caucasian high-risk PCI patients enrolled in the PROTECT II Randomized Controlled Trial (RCT) found that those treated with Abiomed’s Impella heart pump had significantly improved clinical outcomes compared to those treated intravenously. – aortic balloon pump (IABP).
Specifically, the analysis found that, when compared to patients who received IABP, Impella patients experienced:
- A 48% reduction in major adverse events (MAE), the primary endpoint of the PROTECT II RCT, up to 90 days after the procedure. (p=0.018) (see figure 1)
- 60% reduction in severe cardiac and cerebral events (MACCE) up to 90 days after the procedure. (p=0.032) (see figure 2)
- 75% reduction in irreversible events (death, stroke, myocardial infarction) from discharge up to 90 days after the procedure. (p=0.044) (see figure 3)
This subset population analysis was pre-specified in the statistical analysis plan for the primary MAE endpoint of the PROTECT II RCT. Patients in the analysis were included in Abiomed’s regulatory submission to the US Food and Drug Administration (FDA) which led the FDA to grant Impella approval as safe and effective for high-risk PCI.
“These data on the benefits of the Impella-supported procedure for non-Caucasian patients are very compelling and should be used to inform doctors’ clinical decision-making when treating non-Caucasian patients with heart disease,” said William O’Neill, MD , medical director of the Center for Structural Heart Disease at Henry Ford Health and principal investigator of the PROTECT II RCT.
As a result of this subgroup analysis, and many other clinical data showing the benefits of the Impella heart pump in high-risk PCI, cardiogenic shock and right heart failure, Abiomed established a patient assistance program to help reduce disparities in treatment. health care system. The W. Gerald Austen Disparities in Healthcare Initiative will provide assistance to hospitals in the United States and the Bahamas that use Impella’s best practice protocols to treat patients who are on Medicaid or who are underinsured. It is an expansion of Abiomed’s existing diversity initiative.
“Systemic and social factors create disparities in the treatment options available to heart disease patients who are candidates for PCI procedures. This program is a step to correct these disparities and improve health services in underserved communities by helping all patients receive appropriate care when in shock cardiogenic, right heart failure, or requiring Protected PCI,” said Myron Rolle, MD, global neurosurgeon. fellow at Massachusetts General Hospital, chairman of the Caribbean Neurosurgery Foundation and member of the Abiomed Board of Directors. “I am very pleased this initiative will help in the Bahamas, an island nation of over 90% African descent with ischemic heart disease as the number one cause of death.”
This program is named in memory of Dr. Gerald Austen, former chief of surgical services at Massachusetts General Hospital (MGH) and a 37-year member of the Abiomed Board of Directors. Dr. Austen is also the founding president and CEO of the Massachusetts General Physicians Organization, the first physician elected to the MGH Board of Trustees and the founder of the Partners HealthCare system.
“Dr. Austen is an inspiration to the field of cardiology, Mass General Hospital, Abiomed and everyone around her. His life was one of service to patients, medicine and their families. Abiomed will honor Dr. Austen with this healthcare disparity program as a service for patients and communities in need, to which he dedicated his life’s work,” said Michael R. Minogue, Chairman of Abiomed, President and Chief Executive Officer.
For more information on the W. Gerald Austen Disparities in Healthcare Initiative, please visit www.abiomed.com/dih-initiative.