Abiomed Begins PROTECT IV RCT of Impella in High-Risk PCI

April 15, 2021—Abiomed announced that the first patient has been enrolled in the PROTECT IV study of the company’s Impella device. The large, prospective, multicenter randomized controlled trial (RCT) is designed to provide the level of clinical evidence needed to achieve a class I guideline recommendation for Impella in high-risk percutaneous coronary intervention (HRPCI).

According to Abiomed, the two-arm PROTECT IV RCT will compare the benefits of HRPCI 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.

The first patient was enrolled at Ascension St. John Hospital in Detroit, Michigan, by Ted Schreiber, MD, and Amir Kaki, MD.

“This trial aims to generate the highest level of scientific clinical evidence to definitively demonstrate that Impella-supported PCI improves outcomes for high-risk patients, and we are excited to enroll the first patient in the trial,” commented Dr. Schreiber in the company’s press release. “Dr. Kaki and I are proud of the entire team at Ascension St. John Hospital for being at the forefront of cardiovascular research in this landmark RCT.”

The trial’s Principal Investigators are Gregg W. Stone, MD, and Stephan Windecker, MD.

“PROTECT IV is a landmark trial with the potential to revolutionize the interventional treatment of patients with complex coronary artery disease and left ventricular dysfunction,” stated Dr. Stone in Abiomed’s announcement. “This academically led study is designed to provide the highest level of robust evidence to guide management and improve global clinical outcomes for these high-risk patients.”

Dr. Windecker added, “This study is important for the field of interventional cardiology in that it will demonstrate whether forward flow unloading will protect the heart during HRPCI, allowing for more complete revascularization and improved long-term outcomes.”

The company noted that the PROTECT IV RCT will leverage advancements in technology and best practices learned since the completion of the PROTECT II RCT and the FDA premarket approval for Impella 2.5 for HRPCI. Data from PROTECT II found that when compared to intra-aortic balloon pump, Impella 2.5 led to a 29% reduction in major adverse cardiac and cerebrovascular events (MACCE; defined as composite of death, stroke, myocardial infarction, and repeat procedures) at 90 days.

Additionally, PROTECT IV builds on PROTECT III, a contemporary, prospective, single-arm FDA postapproval study of Impella 2.5 and Impella CP for HRPCI.

Interim results from PROTECT III showed a statistically significant improvement in 90-day MACCE rates versus PROTECT II (15% vs 21.9%; P = .035) with lower in-hospital bleeding complications (1.8% vs 12.5%; P < .001) despite substantially sicker and more complex patients. Impella-supported PCI has shown higher rates of optimal and complete revascularization, which leads to improved long-term survival and quality of life, noted Abiomed.

The interim 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.