Abiomed Impella–Supported PCI in High-Risk Patients Studied in Restore EF

August 16, 2022—Abiomed announced that results of the Restore EF study demonstrated that high-risk percutaneous coronary interventions (PCI) supported by the company’s Impella heart pumps led to significant improvements in left ventricular ejection fraction (LVEF), angina symptoms, and heart failure symptoms at follow-up.

Abiomed’s Impella 2.5 and Impella CP with SmartAssist are FDA approved to treat certain advanced heart failure patients undergoing elective and urgent PCI, such as stenting or balloon angioplasty, to reopen blocked coronary arteries.

According to the company, the study 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.

The findings were published by Jason Wollmuth, MD, et al online in JSCAI, the Journal of the Society of Cardiovascular Angiography and Interventions.

According to Abiomed, Restore EF is a prospective, multicenter study evaluating the best practices in contemporary PCI practice, including more complete revascularization. Patients in the study received an Impella-supported high-risk PCI (“on-pump PCI”) at one of 22 sites across the United States between August 2019 and May 2021.

As summarized in the company’s press release, at 90-day follow up, study patients showed the following results:

• A 29% relative improvement from baseline LVEF (n = 251; P < .0001), with a significantly greater improvement in LVEF for those patients who had a complete revascularization (residual SYNTAX score of 0)
• 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 < .001)
• Significant improvement in angina symptoms, with an overall 97% reduction in Canadian Cardiovascular Society Class III or IV angina symptoms (n = 260; P < .0001)

Participants with higher baseline LVEF (> 45%) also experienced significant symptomatic improvement, similar to patients with lower LVEF.

Dr. Wollmuth, who is an interventional cardiologist at Providence Heart Institute in Portland, Oregon, serves as the Restore EF study’s Principal Investigator.

“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,” commented Dr. Wollmuth in Abiomed’s press release. “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 FDA’s 2018 decision to expand Impella’s indication to patients undergoing high-risk PCI with or without depressed ejection fractions.”

In an accompanying editorial in JSCAI, Akl C. Fahed, MD, and Farouc A. Jaffer, MD, concluded, “Based on the encouraging report from Wollmuth et al, a heart team–based recommendation for PCI in coronary artery bypass graft–ineligible patients appears reasonable for patients with ischemic cardiomyopathy.” Dr. Fahed and Dr. Jaffer are with Massachusetts General Hospital and Harvard Medical School in Boston, Massachusetts.

Abiomed stated that results from Restore EF and the PROTECT III study further demonstrate the safety and benefits of Impella-supported high-risk PCI, including low rates of bleeding and major adverse cardiac and cerebrovascular event (MACCE, a composite of death, stroke, myocardial infarction, and repeat procedures). The PROTECT III findings were published in June by William W. O'Neill, MD, et al in the American Heart Journal (2022; 248:139-149).

According to Abiomed, data from PROTECT III showed reduced MACCE rates compared to PROTECT II (15.1% vs 21.9%; P = .037) when Impella is used to achieve a more complete revascularization in a single setting for high-risk PCI patients. Interventionalists 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.

Also in the company’s press release, Restore EF investigator Mitul Patel, MD, an interventional cardiologist at UC San Diego Health in San Diego, California, commented, “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.”

The company noted that Restore EF and PROTECT III are the latest in a series of studies that demonstrate Impella-supported high-risk PCI leads to improvement in LVEF.

The latest in the series of studies is PROTECT IV. In April 2021, Abiomed announced the commencement of enrollment in the study to provide the level of clinical evidence needed to achieve a class I guideline recommendation for Impella in high-risk PCI. The two-arm PROTECT IV randomized controlled trial will compare the benefits of high-risk PCI with versus without Impella support. The primary endpoint of the study is the composite of all-cause death, stroke, myocardial infarction, or hospitalization for cardiovascular causes at a minimum of 1 year. The trial, which has an adaptive design, aims to enroll 1,252 consecutive qualified patients at more than 100 hospital sites across the United States and Europe.