Clinical Research & Data, Protected PCI
HFSA 2021: Clinical Evidence to Support ‘On-Pump’ Complex PCI in Heart Failure
Navin Kapur, MD, discusses clinical evidence for what he calls “on-pump” complex PCI, especially related to patients with heart failure. 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 at the 2021 Heart Failure Society of America (HFSA) scientific meeting.
“There’s been a significant evolution in the field of interventional [cardiology] to the point that techniques now, that exist in mainstream interventional labs, did not exist 10 years ago,” Dr. Kapur tells the HFSA audience, explaining that a community built around complex high-risk PCI (CHIP) is training interventional heart failure hybrid fellows on selecting patients and optimizing their outcomes using Protected PCI. “At the end of the day, for patients who are high risk for surgery and also who have medium- or high-risk anatomic substrates, those are the patients who we would consider for mechanical support in PCI,” Dr. Kapur explains. “These patients who were considered high risk for surgery now have an exit strategy because they can now undergo PCI in a much safer condition, with a more complete revascularization result.”
Dr. Kapur reviews data supporting the clinical rationale for revascularization in heart failure and looks at criteria associated with surgical ineligibility, many of which are comorbidities typically seen in the heart failure population. Today, many of these patients, he emphasizes, are candidates for potential high-risk or complex PCI.
He then reviews PROTECT II randomized controlled trial (RCT) data and explains how it led to the FDA post-approval study PROTECT III. Best practices emerging from PROTECT III—complete revascularization in a single setting, atherectomy, and large-bore access techniques—were then validated in RESTORE EF, which demonstrated significant improvement in ejection fraction within 90 days of revascularization using best practices, even in patients considered too high-risk for surgery. “So that’s a significant observation suggesting the potential for myocardial recovery with revascularization using contemporary best practices.”
All this clinical evidence led to the development of the PROTECT IV RCT, which Dr. Kapur refers to “a heart failure trial,” designed to be the largest RCT in the setting of complex PCI. “It’s about as rigorous as you can get in terms of a look at your patient population with low EF being referred for complex PCI,” Dr. Kapur emphasizes to the HFSA audience.
Dr. Kapur encourages the heart failure community to embrace PROTECT IV and consider enrolling patients. “Because if your focus is myocardial recovery, optimization of patient outcomes, reducing the burden of drugs or devices that patients may subsequently receive for heart failure, this is one option for those patients.”