PROTECT III Data Continues to Demonstrate Reduced MACCE with Impella®
Dr. Jeffrey Popma examines the current clinical evidence for Protected PCI with left ventricular support, including new PROTECT III data from an ongoing FDA post-approval study. Dr Popma is director of interventional cardiology clinical services at Beth Israel Deaconess Medical Center in Boston.
“I think that we are in a very good place now,” Dr. Popma emphasizes, “with our understanding and clinical evidence base for high-risk PCI with left ventricular support.” In this presentation, Dr. Popma discusses:
- Large comparative trials of complex PCI vs CABG and complex PCI with or without the use of support devices
- Safety and efficacy analyses from the PROTECT II randomized controlled clinical trial
- New data on the importance of complete revascularization in PROTECT II
- The ongoing PROTECT III study and future trials addressing the importance of ventricular support in patients undergoing complex PCI
Dr. Popma summarizes what we learned from PROTECT II as follows:
- Procedural benefits of hemodynamically Protected PCI with Impella: fewer hypotensive events, higher cardiac power output, and facilitation of more extensive atherectomy
- Clinical benefit of Impella Protected PCI: reduction of major adverse events post-discharge accompanied by an improvement in ventricular function and heart failure symptoms
- Post-discharge clinical benefits more pronounced in patients who underwent more complete revascularization with Impella support
Dr. Popma then discusses what we’ve learned since PROTECT II, stating: “Probably the most important post-market study that we’ve got ongoing right now is PROTECT III.” PROTECT III involves 45 clinical sites around the country with 898 patients enrolled between March 2017 and July 2019 and enrollment is ongoing. Dr. Popma notes the prominent principal investigators, the high quality clinical data sites, the core labs that examine the angiograms at Beth Israel Deaconess Medical Center and echocardiograms at Yale Cardiovascular Clinical Research, the institutional review board approval, and the independent clinical events committee looking at all the events. “It’s a glimpse into current clinical practice that’s adjudicated, and managed, and provides incredibly sound and robust clinical data.”
Dr. Popma draws the following conclusions from the data he’s presented:
- The “high-risk” indication for PCI is founded on a procedural benefit of hemodynamic stability enabling a more thorough revascularization and leading to a post-discharge clinical benefit of reduced adverse events and improved cardiac function.
- Decisions to provide hemodynamic support during PCI should accordingly be made in the context of providing complete revascularization and evaluated based on improvement in outcomes out of hospital.
- In the post-approval era, compared to PROTECT II, PROTECT III patients are older, include more women, and receive more complex procedures, yet 90-day MACCE is lower.
- Emerging data validated in the multicenter cVAD Study indicate a potential additional benefit in these patients to reduce the risk of acute kidney injury (AKI).
“Our knowledge will continue to accelerate over time,” Dr. Popma notes, “and certainly we’ll understand the benefits of helping patients who have reduced ventricular function.”
- PROTECT Series of Clinical Studies Provides Mounting Evidence for Impella Support in High-risk PCI
- Impella Support and Acute Kidney Injury During High-Risk PCI
- PROTECT Series FAQ
To learn more about the Impella® platform of heart pumps, including important risk and safety information associated with the use of the devices, please visit: www.protectedpci.com/indications-use-safety-information/