PROTECT III Data Presented for Abiomed's Impella 2.5 and CP Devices for High-Risk PCI

September 26, 2019—Abiomed, Inc. announced that results from the PROTECT III study, an ongoing, prospective, single-arm FDA postapproval study for postmarket approval of the company’s Impella 2.5 and Impella CP devices for use in high-risk percutaneous coronary intervention (PCI) were presented by Jeffrey J. Popma, MD, at the 31st Transcatheter Cardiovascular Therapeutics (TCT) conference held September 25–29, in San Francisco, California. Dr. Popma is Director of Interventional Cardiology Clinical Services at Beth Israel Deaconess Medical Center, in Boston, Massachusetts, and a member of the study’s steering committee.

According to the company, PROTECT III data demonstrate a reduction in the primary endpoint of major adverse cardiac and cerebrovascular events (MACCE; ie, death, stroke, myocardial infarction, and repeat procedures at 90 days) with Impella-supported Protected PCI, compared with the earlier PROTECT II randomized controlled trial (RCT).

The data presented were from an interim analysis of 898 patients enrolled at 45 sites in the United States between March 2017 and July 2019. Compared with the PROTECT II study, patients in PROTECT III are statistically older (mean, 71 years), include more women (26%) and non-Caucasians (33%), received longer support, and had more complex procedures with more vessels.

As presented, the 90-day MACCE rate in PROTECT III was lower than the intra-aortic balloon pump (IABP) control arm from PROTECT II. Composite MACCE rate in the IABP arm was 31%, compared with the Impella 2.5 and Impella CP arm at 16.8% (P < .0001).

“Based on the learnings from the PROTECT studies, decisions to provide hemodynamic support during PCI should be made in the context of providing complete revascularization and patient outcomes should include in-hospital and out-of-hospital improvements,” said Dr. Popma in the company’s announcement. “Prior studies have demonstrated it is important to achieve complete revascularization because it can result in a 30% to 50% reduction in MACCE, compared to incomplete revascularization.”

According to Abiomed, the PROTECT Series (PROTECT I, the PROTECT II RCT, and PROTECT III) now includes 1,366 patients.

“The totality of clinical data in favor of Impella supported high-risk PCI allows interventional cardiologists to be confident they are using the optimal treatment and technologies to help achieve complete revascularization in a single setting, improve procedural hemodynamic stability and improve patient quality of life,” commented William O’Neill, MD, Medical Director of the Center for Structural Heart Disease at Henry Ford Hospital, in Detroit, Michigan.