Clinical Trial Update with Chuck Simonton, MD

Chuck Simonton, MD, provides an update on Impella® clinical trials: PROTECT III, RESTORE EF, and PROTECT IV RCT, as well mentioning the REVIVED BCIC2 study recently presented at the European Society of Cardiology (ESC) Congress 2022. This discussion was part of a larger Protected PCI webinar featuring presentations by Christophe Vandenbriele, MD, and Vasileios Panoulas, MD.

Dr. Simonton begins with an overview of complex coronary artery disease (CAD) patients and the PROTECT series of clinical studies. He shows the most recent data from PROTECT III illustrating improved outcomes with contemporary practices (MACCE 15.1% in PROTECT II-like patients in PROTECT III compared to 21.9% in the Impella arm of PROTECT II and 31.0% in the IABP arm of PROTECT II). This improvement is seen in patients with more complex lesions and procedural characteristics than the PROTECT II patient population. In addition, PROTECT III demonstrated more complete revascularization with less hypotension during support compared with PROTECT II and improved 90-day MACCE in propensity score matched cohorts.
Dr. Simonton reviews the recently published RESTORE EF study demonstrating 90-day left ventricular ejection fraction (LVEF) improvement following Impella-supported high-risk PCI and significant improvement in heart failure and angina symptoms (76% reduction in NYHA class III, IV heart failure symptoms and 97% reduction in CCS angina class III, IV symptoms) with more pronounced EF improvement in patients with severe and moderately depressed EF. Patients with near normal EF also had significant symptom improvement.

Next, Dr. Simonton mentions the REVIVED BCIS2 study that was presented at the ESC Congress 2022 in Barcelona, Spain. He provides insights into why all-cause death or heart failure hospitalization did not differ between the PCI and optimal medical therapy (OMT) arms in the study, noting study limitations in patient baseline characteristics, minimal use of Impella, and limited contemporary practices and techniques.

Finally, Dr. Simonton describes the study design for the PROTECT IV RCT, which as of September 2022, is enrolling patients at 60 sites in the US and EU with 247 patients (20% of the target) already randomized. “We’re still recruiting sites for the PROTECT IV study,” Simonton concludes.