Data from the PROTECT III FDA post-approval study of Impella 2.5 and Impella CP in high-risk percutaneous coronary intervention (PCI) patients showed reduced rates of MACCE — a composite of death, stroke, myocardial infarction and repeat procedures.
PROTECT III builds on the PROTECT II randomized controlled trial (RCT) which found, when compared to intra-aortic balloon pump (IABP), Impella use led to a 29% reduction in MACCE at 90 days, the company said.
Patients selected for PROTECT III would have qualified for PROTECT II but were older, sicker and more complex, with more comorbidities, more vessels treated and more rotational atherectomy, according to Abiomed. These “PII-like” patients in PROTECT III had improved 90-day MACCE rates, compared to PROTECT II patients (15% vs. 21.9%, p=0.035).
The PROTECT series of FDA clinical studies, which includes PROTECT I, the PROTECT II RCT and PROTECT III, is the largest-ever FDA study of hemodynamically supported high-risk PCI patients. The PROTECT III interim analysis included 1,143 patients undergoing elective, non-emergent PCI with Impella at 45 sites between March 2017 and September 2019.
The study also found PII-like patients in PROTECT III they had improved in-hospital safety with:
- Significantly fewer bleeding complications (1.8% vs. 12.5%, p<0.001).
- Similar low vascular complications (1.0% vs. 1.4%, p=0.659).
- Similar low instances of stroke (0.40% vs. 0.46%, p=0.913).
“This data is an important continuation of knowledge in high-risk PCI. Looking back at PROTECT II data, we understood the safety and efficacy of Impella,” said lead investigator Dr. Jeffrey W. Moses, director of interventional cardiovascular therapeutics and professor of medicine at Columbia University Medical Center, in a news release. “But now, with PROTECT III showing fewer adverse events, we understand how to apply best practices and the result is better patient outcomes.”
Dr. William O’Neill, medical director of the Center for Structural Heart Disease at Henry Ford Hospital, is scheduled to present the results at TCT Connect, the 32nd annual scientific symposium of the Cardiovascular Research Foundation, as a part of the “Best of Abstracts” session at 3:24 p.m. EDT today.
“This novel, contemporary data from PROTECT III clearly demonstrates 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,” O’Neill said in the news release.
The PROTECT III post-approval study will inform best practice protocols for the upcoming prospective, two-arm PROTECT IV RCT, which will use and validate findings 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. The first patient is expected to enroll in 2021.