Abiomed has announced the results of the Restore EF study, demonstrating that 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 findings of the study, published online this month in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI), build on the largest clinical dataset collected for high-risk PCI and further validate the LVEF and quality of life benefits associated with Impella-supported procedures, the company said in a press release.
Restore EF is a prospective, multicentre study evaluating the best practices in contemporary PCI practice, including more complete revascularisation. Participants received an Impella-supported high-risk PCI, also called an “on-pump PCI,” at one of 22 sites across the USA between August 2019 and May 2021. At 90-day follow up, study participants had:
- A 29% relative improvement from baseline LVEF (n=251, p<0.0001), with a significantly greater improvement in LVEF for those who had a complete revascularisation (characterized by a residual SYNTAX score of 0). (See figures 1 and 2)
- Significant improvement in heart failure symptoms, with an overall 76% reduction 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 97% reduction 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 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 revascularisation and considerable LVEF improvement,” said Jason Wollmuth (Providence Heart Institute, Spokane, USA) Restore EF study principal investigator. “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 US Food and Drug Administration’s (FDA’s) 2018 decision to expand Impella’s 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 team–based recommendation for PCI in CABG-ineligible patients appears reasonable for patients with ICM (ischaemic 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 revascularisation in a single setting for high-risk PCI patients. Operators from community and academic centres 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 (UC San Diego Health, San Diego, USA), the study’s first author.