Consistent evidence supports benefits of complete revascularization on LVEF, heart failure symptoms
DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (Nasdaq: ABMD) announces the results of the Restore EF study demonstrate Impella-supported high-risk percutaneous coronary intervention (PCI) leads to significant improvements in left ventricular ejection fraction (LVEF), angina symptoms and heart failure symptoms at follow-up. The study, which published online August 12 in JSCAI, builds on the largest clinical data set ever collected for high-risk PCI and further validates the LVEF and quality of life benefits associated with Impella-supported procedures.
Restore EF is a prospective, multi-center study evaluating the best practices in contemporary PCI practice, including more complete revascularization. Participants received an Impella-supported high-risk PCI, also called an �on-pump PCI, at one of 22 sites across the United States between August 2019 and May 2021. At 90-day follow up, study participants had:
Participants with higher baseline LVEF (greater than 45%) also experienced significant symptomatic improvement, similar to patients with lower LVEF.
The Restore EF study results add to the growing body of evidence demonstrating that Impella-supported high-risk PCI can lead to a more complete revascularization and considerable LVEF improvement, said Jason Wollmuth, MD, Restore EF study principal investigator and an interventional cardiologist at Providence Heart Institute. The improvement in angina and heart failure symptoms in those with near normal LVEF provides a clear benefit to this patient population that is aligned with the FDAs 2018 decision to expand Impellas indication to patients undergoing high-risk PCI with or without depressed ejection fractions.
An accompanying editorial published in JSCAI, written by physicians from Massachusetts General Hospital and Harvard Medical School, concludes, “based on the encouraging report from Wollmuth et al, a heart teambased recommendation for PCI in CABG-ineligible patients appears reasonable for patients with ICM (ischemic cardiomyopathy).”
Results from Restore EF and the PROTECT III study, which published in the June 2022 edition of the American Heart Journal, further demonstrate the safety and benefits of Impella-supported high-risk PCI, including low bleeding and MACCE rates (composite of death, stroke, myocardial infarction and repeat procedures). Data from PROTECT III shows reduced MACCE rates compared to PROTECT II (15.1% vs. 21.9%, p=0.037) when Impella is used to achieve a more complete revascularization in a single setting for high-risk PCI patients. Operators from community and academic centers demonstrated low major bleeding rates of 2.5% in the Restore EF study and 1.8% in the PROTECT III study when contemporary best practices were followed.
These results further demonstrate that high-risk PCI procedures supported by Impella employing contemporary best practices are safe and effective, providing a treatment option for patients who have historically had limited options to improve their quality of life, said Mitul Patel, MD, the studys first author and an interventional cardiologist at UC San Diego Health.
Restore EF and PROTECT III are the latest in a growing list of studies that demonstrate Impella-supported high-risk PCI leads to improvement in LVEF:
These studies have led to the PROTECT IV randomized controlled trial, which began enrolling patients in April 2021. PROTECT IV compares on-pump PCI to off-pump PCI and is the final step on the clinical evidence pathway to a Class I recommendation for Impella use in high-risk PCI. PROTECT IV leverages the best practices that physicians have learned during the past 10 years of clinical studies that led to the exclusive FDA PMA approval of Impella for high-risk PCI.
Additional information about the Restore EF study, including case studies and interviews with the studys authors, is available on HeartRecovery.com.
ABOUT IMPELLA HEART PUMPS
The Impella 2.5® and Impella CP® with SmartAssist® are US FDA approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI), such as stenting or balloon angioplasty, to reopen blocked coronary arteries.
ABOUT ABIOMED
Based in Danvers, Massachusetts, USA, Abiomed, Inc., is a leading provider of medical technology that provides circulatory support and oxygenation. Our products are designed to enable the heart to rest by improving blood flow and/or provide sufficient oxygenation to those in respiratory failure. For additional information, please visit: http://www.abiomed.com/.
FORWARD-LOOKING STATEMENTS
Any forward-looking statements are subject to risks and uncertainties such as those described in Abiomed’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
Contacts
Media Contact:
Jenny Leary
Associate Director, U.S. Communications
+1 (978) 882-8491
jleary@abiomed.com
Investor Contact:
Todd Trapp
Vice President and Chief Financial Officer
+1 (978) 646-1680
ttrapp@abiomed.com
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