Consistent Benefits in terms of assistance for complete revascularization in LVEF and symptoms of heart failure
Abiomed (Nasdaq: ABMD) Announces Results from the Restore EF Study Demonstrating that High-Risk Percutaneous Coronary Intervention (PCI) Using the Impella Pump Leads to Significant Improvements in Left Ventricular Ejection Fraction (LVEF), angina symptoms and heart failure symptoms during follow-up. The study, which was published online Aug. 12 in JSCAI, builds on the largest set of clinical data ever collected on high-risk PCI, and further validates LVEF and quality benefits life associated with procedures using the Impella pump.
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Figure 1: 90-Day LVEF Improvement Following Impella-Supported High-Risk PCI
Restore EF is a prospective, multicenter study evaluating best practices in modern PCI, including complete revascularization. Participants received high-risk PCI using the Impella pump, also known as “pumping PCI,” at one of 22 sites in the United States between August 2019 and May 2021. At 90-day follow-up, participants study participants had:
a 29% relative improvement from baseline LVEF (n=251, p<0.0001), with significantly greater improvement in LVEF for participants who achieved complete revascularization (characterized by a residual SYNTAX score of 0). (See figures 1 and 2)
significant improvement in heart failure symptoms, with an overall reduction of 76% in New York Heart Association class III or IV heart failure symptoms (n=274, p<0.001). (See figure 3)
significant improvement in angina symptoms, with an overall reduction of 97% in Canadian Cardiovascular Society class III or IV angina symptoms (n=260, p<0.0001). (See Figure 4)
Participants with higher baseline LVEF (greater than 45%) also showed significant symptomatic improvement, similar to patients with lower LVEF.
“The results of the Restore EF study add to the body of evidence demonstrating that high-risk PCI using the Impella pump can lead to more complete revascularization and dramatic improvement in LVEF,” says Jason Wollmuth, MD, principal investigator of the Restore EF study and interventional cardiologist at Providence Heart Institute. “The improvement in angina and heart failure symptoms in patients with near-normal LVEF is a clear benefit for this patient population, in line with the 2018 decision to extend the indication of the Impella pump to patients who have undergone high-risk PCI with or without depressed ejection fraction”.
An editorial in JSCAI, written by physicians from Massachusetts General Hospital and Harvard Medical School, concludes: “According to the encouraging report by Wollmuth et al., a recommendation by a team of cardiologists for PCI in patients ineligible for CABG seems reasonable for patients with ischemic cardiomyopathy”.
Results from the Restore EF study and the PROTECT III study, which was published in the June 2022 edition of the American Heart Journal, further demonstrate the safety and benefits of high risk using the Impella pump, including low bleeding rates and MACCE (total deaths, stroke, myocardial infarction and repeat procedures). PROTECT III data show reduced MACCE rates compared to PROTECT II (15.1% vs 21.9%, p=0.037) when Impella is used to achieve more complete revascularization in a single setting for patients who have undergone High risk PCI. Community and academic center operators reported low rates of major bleeding, 2.5% in the Restore EF study and 1.8% in the PROTECT III study, when contemporary best practices were applied .
“These results further demonstrate that high-risk PCI using the Impella pump and contemporary best practices are safe and effective, providing a treatment option for patients who have historically had limited options to improve their quality. life,” says Mitul Patel, MD, the study’s first author and interventional cardiologist at UC San Diego Health.
Restore EF and PROTECT III are the latest in a growing list of studies demonstrating that high-risk PCI using the Impella Pump leads to improved LVEF:
Journal of the American College of Cardiology, 2009 – The PROTECT I trial demonstrated that patients who received protected PCI using the Impella pump had a 31% improvement in LVEF at 30-day follow-up. (From 26 ± 6% to 34 ± 11%, p=0.003).
Catheterization and Cardiovascular Interventions, 2011 – This study, led by Maini, et al., demonstrated a 17% improvement in LVEF at follow-up after protected PCI using the Impella pump (p<0.0001) .
Traffic, 2012 – The randomized, controlled PROTECT II trial demonstrated that protected PCI using the Impella pump led to a 58% improvement in NYHA Class III and IV heart failure symptoms at 90 days (p <0.001). The trial also demonstrated that during follow-up after protected PCI using the Impella pump, patients showed a 22% improvement in LVEF (p<0.001).
Journal of Interventional Cardiology, 2013 – This study, led by O’Neill, et al., indicates that earlier initiation of hemodynamic support before PCI using the Impella 2.5 pump is associated with more complete revascularization and improved survival to discharge compared to post PCI support (65.1% vs 40.7%, p<0.003).
American Journal of Cardiology, 2013 – An analysis of the randomized, controlled PROTECT II trial led by Dangas, et al., demonstrated that use of the Impella pump led to a 29% reduction in cardiac and cerebrovascular events (MACCE) at 90 days, compared to the use of the intra-aortic balloon pump (IABP) (p=0.042).
Journal of Interventional Cardiology, 2019 – This study, led by Burzotta, et al., demonstrated that six months after protected PCI, the percentage of patients with an LVEF greater than or equal to 35% increased by 205%, 22% at 67% (n=79, p≤0.001). The study also showed that more complete revascularization was associated with significantly improved LVEF and survival.
These studies culminated in the randomized, controlled PROTECT IV trial, which began enrollment in April 2021. PROTECT IV compares PCI with pumping versus PCI without pumping, and is the final step in the clinical evidence journey towards a Class I recommendation for use of the Impella pump in high-risk PCIs. PROTECT IV builds on the best practices physicians have learned over the past decade from the clinical studies that led to FDA PMA approval for the Impella pump in high-risk PCI.
Additional information about the Restore EF study, including case studies and interviews with study authors, is available at HeartRecovery.com.
ABOUT IMPELLA HEART PUMPS
Impella 2.5® and Impella CP® with SmartAssist® are approved by the US FDA to treat certain patients with advanced heart failure undergoing elective and urgent percutaneous coronary interventions (PCI), such as stenting or angioplasty by balloon, to reopen clogged coronary arteries.
ABOUT ABIOMED
Based in Danvers, Massachusetts, USA, Abiomed, Inc. is a leading provider of circulatory support and oxygenation medical technology. Our products are designed to allow the heart to rest by improving blood flow and/or providing sufficient oxygenation to people with respiratory failure. For more information, please visit the site at: http://www.abiomed.com/.
FORWARD-LOOKING STATEMENTS
All forward-looking statements are subject to risks and uncertainties such as those described in Abiomed’s periodic reports filed with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
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