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October 14, 2020

Abiomed’s Restore EF Study Demonstrates Impella-Supported High-Risk PCI Improves LVEF

October 14, 2020—Abiomed announced that findings from the Restore EF study demonstrated that the use of contemporary best practices—including attempting a more complete revascularization with the company’s Impella-supported high-risk percutaneous coronary intervention (PCI)—is associated with significant improvement of left ventricular ejection fraction (LVEF), heart failure symptoms, and anginal symptoms at follow-up.

The interim analysis of the Restore EF findings was presented by Mitul Patel, MD, at TCT Connect, the 32nd annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held online October 14-18, 2020.

According to Abiomed, the ongoing, multicenter, prospective, single-arm study enrolled 193 consecutive qualified patients who underwent a protected PCI procedure with Impella between September 2019 and September 2020 at 19 hospitals in the United States, representing a variety of hospital settings including rural, urban, community, and academic centers.

The interim analysis showed:

  • Significant median LVEF improvement from baseline to 90-day follow up (31% to 45%; P < .0001); LVEF improvement at 90 days is the study’s primary endpoint
  • Significant reduction of heart failure symptoms with 80% reduction in New York Heart Association (NYHA) classification III/IV at follow up (54% to 11%; P < .001)
  • Significant reduction of anginal symptoms with 99% reduction in Canadian Cardiovascular Society (CCS) classification III/IV at follow up (70% to 1%; P < .0001)

“Restore EF demonstrates Impella-supported PCI patients have shown a significant LVEF improvement at 90 days,” commented Dr. Patel in Abiomed’s announcement. “The study also found a significant improvement in heart failure and anginal symptoms assessed with NYHA and CCS functional classifications. Taken together, [these] data validate best practices for treating high-risk PCI patients, including the use of Impella to achieve a complete revascularization in a single setting.”

Jason Wollmuth, MD, a Coprincipal Investigator of the Restore EF study, stated, “High-risk PCI patients often pose a revascularization challenge due to patient comorbidities, poor LV function, and adverse hemodynamics, which drive worse outcomes. This research demonstrates the rationale for using Impella support during high-risk PCI to maintain coronary perfusion and support hemodynamics during periods of myocardial ischemia during long or repeated balloon inflations or atherectomy runs. This allows providers to achieve complete functional revascularization and the best possible outcomes for our patients.”

Findings from Restore EF will be used to inform the study protocol for the upcoming prospective, two-arm PROTECT IV randomized controlled trial. The trial will compare complete revascularization PCI with Impella to complete revascularization PCI without any planned hemodynamic support. PROTECT IV is part of the Impella clinical evidence pathway to a class I clinical guideline recommendation for high-risk PCI, advised Abiomed.

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