Clinical Research & Data, Protected PCI
HFSA 2021: Identifying Patients for PROTECT IV
Navin Kapur, MD, FACC, FSCAI, FAHA, discusses the importance of identifying patients with heart failure who can be referred for enrollment in the PROTECT IV randomized controlled trial (RCT). Dr. Kapur is a heart failure cardiologist and an interventional cardiologist, serving as associate professor of medicine at Tufts University and the executive director of the CardioVascular Center for Research and Innovation. He gave this presentation virtually at the 2021 Heart Failure Society of America (HFSA) Annual Scientific Meeting.
Dr. Kapur begins by explaining the importance of coronary revascularization and reversing myocardial remodeling. He describes how energy production switches from fatty acid oxidation (FAO) to glycolysis and becomes inefficient in heart failure. “As a result, this idea of revascularizing has implications that go far beyond just the immediate period of getting the coronary artery open and resolving anginal symptoms. It has a significant impact on remodeling as well as myocardial energetics. And so that’s why this trial, PROTECT IV, I think is so critical, because it starts to change that trajectory by providing that complete revascularization with minimal surgical insult.”
Dr. Kapur briefly discusses the STEMI DTU™ RCT, a myocardial recovery trial that, like PROTECT IV, entails high-risk PCI with mechanical circulatory support (MCS), also known as Protected PCI. Dr. Kapur emphasizes the critical role heart failure physicians play in conversations about Protected PCI and the importance of the heart team approach in selecting patients for PROTECT IV.
“And what we’re looking for, primarily, are those patients with heart failure who have revascularizable coronary anatomy,” Dr. Kapur explains. He reviews a list of characteristics of patients to refer for PROTECT IV, which includes clinical factors that favor PCI over CABG in patients with HFrEF:
- Advanced HF and poor candidate for LVAD or transplant
- Previous CABG
- Advanced age
- Marginal RV function
- Calcified aorta
- Late presentation STEMI with LV scar/aneurysm
- Multi-organ disease (i.e., chronic kidney disease)
- High risk for stroke or neurologic comorbidities
The PROTECT IV study design, he emphasizes, is focused on patients with HFrEF. He describes how patients are randomized to either Impella-supported PCI or standard of care, which can be PCI with or without IABP support.
Dr. Kapur discusses the importance of having an algorithm to help identify clinical features indicative of consideration for MCS and introduces an algorithm he refers to as the “McCabe PPCI Score” developed by Jamie McCabe, MD. This score, he explains, can help physicians determine whether patients should be enrolled in PROTECT IV.