October 15, 2020
Interim Analysis Presented From PROTECT III Study of Abiomed’s Impella Device in High-Risk PCI Patients
October 15, 2020—Abiomed announced that new data from an interim analysis of the PROTECT III study demonstrate reduced rates of major adverse cardiac and cerebrovascular events (MACCEs; a composite of death, stroke, myocardial infarction, and repeat procedures) when the company’s Impella device is used to achieve more complete revascularization in a single setting for high-risk percutaneous coronary intervention (PCI) patients. PROTECT III is an ongoing, prospective, single-arm FDA postapproval study of Impella 2.5 and Impella CP in high-risk PCI.
The PROTECT III findings were presented by William O’Neill, MD, at TCT Connect, the 32nd annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held online October 14-18, 2020.
“[These] novel, contemporary data from PROTECT III clearly demonstrate how the evolution and adoption of Impella best practices can lead to an improvement in safety and MACCE and it provides important information as we prepare for the upcoming PROTECT IV randomized controlled trial of Impella in high-risk PCI,” commented Dr. O’Neill in the company’s press release.
According to Abiomed, PROTECT III builds on the PROTECT II randomized controlled trial (RCT), which found that Impella use led to a 29% reduction in MACCE at 90 days when compared with an intra-aortic balloon pump. PROTECT II was published by Dr. O'Neill et al in Circulation (2012;126:1717-1727)
The interim analysis was composed of 1,143 patients undergoing elective nonemergent PCI with Impella at 45 sites between March 2017 and September 2019. The study investigators analyzed patients in PROTECT III who would have qualified for PROTECT II (“PII-like” patients) and compared them to PROTECT II patients.
The findings showed that PII-like patients in PROTECT III had improved 90-day MACCE rates, compared with PROTECT II patients (15% vs 21.9%; P = .035).
Additionally, PII-like patients in PROTECT III were older, sicker, and more complex, with more comorbidities, more vessels treated, and more rotational atherectomy. However, they had improved in-hospital safety with significantly fewer bleeding complications (1.8% vs 12.5%: P < .001); similar low vascular complications (1.0% vs 1.4%; P = .659); and similar low instances of stroke (0.4% vs 0.46%; P = .913).
Jeffrey W. Moses, MD, a PROTECT III lead investigator, stated in Abiomed’s announcement, “[These] data [are] an important continuation of knowledge in high-risk PCI. Looking back at PROTECT II data, we understood the safety and efficacy of Impella. But now, with PROTECT III showing fewer adverse events, we understand how to apply best practices and the result is better patient outcomes.”
The PROTECT series of FDA clinical studies, evaluating hemodynamically supported high-risk PCI patients. PROTECT III is part of a growing body of evidence supporting the benefits of more complete revascularization in high-risk PCI. The PROTECT III postapproval study will inform best practice protocols for the upcoming prospective, two-arm PROTECT IV RCT, which will leverage and validate key learnings from the cVAD study, Impella Quality (IQ) database, and real-world data collected since the completion of the PROTECT II RCT. PROTECT IV will compare complete revascularization PCI with Impella to complete revascularization PCI without any planned hemodynamic support, advised Abiomed.