The PROTECT Series: RCT and Real-World Data from Jeffrey Popma, MD

 

Jeffrey Popma, MD, discusses the clinical evidence supporting protected PCI with the Impella® heart pump. Dr. Popma is a professor of medicine at Harvard Medical School and the director of interventional cardiology at Beth Israel Deaconess Medical Center in Boston.

“The clinical evidence evolves,” Dr. Popma tells interviewer Seth Bilazarian, MD. “And I have to say that good randomized clinical trials, in very difficult subsets, it’s a gift that keeps on giving.” Dr. Popma explains that much has been learned from the PROTECT II study data, notably the impact of patient selection, the impact of procedural expertise and the learning curve, and that the extent of revascularization is an important component for establishing efficacy.

Dr. Popma also explains that from PROTECT II we have gained a good understanding that Impella works to provide hemodynamic support. “We know that,” he emphasizes. “That’s why we do it during STEMIs, we use it during high-risk PCI. When we’re doing the procedure, we want to have the blood pressure preserved. And we feel confident. Everybody does. We know everybody feels confident because of all the rotational atherectomy that gets done with this. And that was almost contraindicated in patients with reduced ventricular function.”

Dr. Popma also notes that important data is emerging on acute kidney injury and the benefits of Impella support.

“We also learned that you can’t just go in to putt,” Dr. Popma states. “You’ve got to step up to the driving range and you’ve got to hit the ball.” When performing revascularization, he explains, you have to think about how many vessels you are going to fix and how to do that efficiently and quickly while minimizing contrast. And you have to do as much revascularization as you can.

Dr. Popma tells Dr. Bilazarian that data from complex higher-risk indicated patients—“the CHIP movement”—has been important for moving the ball forward in terms of more complete revascularization in a single setting. “The concept of staged revascularization,” he explains, “doesn’t work for anybody. It doesn’t work for the patient. It doesn’t work for the hospital.” He explains that an important advantage of Impella is that it helps enable safe revascularization, especially given PROTECT III findings that 40% of patients are getting rotational atherectomy during protected PCI.

Dr. Popma also discusses how interventionalists should think about real world data collection, like PROTECT III. “I think of it, from a trialist’s perspective, as generalizability.” He explains how PROTECT III is “all comers” and how it takes away the inclusion and exclusion criteria. He emphasizes that it is important to “make sure that we can take the randomized clinical trial and generalize it to patients who are undergoing complex PCI.”

 

 

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