Role of Protected PCI in Diagnosis and Treatment of High-Risk CAD

Watch five expert cardiologists discuss the role of Protected PCI in diagnosis and treatment of high-risk coronary artery disease (CAD) in this presentation from the American College of Cardiology 2021 (ACC21) virtual scientific session.

Jason Wollmuth, MD, presents interim data from the ongoing RESTORE EF trial highlighting the impact of Protected PCI on long-term ejection fraction. “Looking at the LVEF improvement at 90 days,” Dr. Wollmuth states, “you can see that there was a significant improvement when looking at all-comers, with an average ejection fraction increasing from 31% to up to 45% at the 90-day follow-up.” Dr. Wollmuth also explains that, from the data to date, heart failure and anginal symptoms are markedly improved after revascularization and the extent of complete revascularization is associated with an improvement in LVEF.

William O’Neill, MD, reviews data from PROTECT III, the largest prospective study of Impella® use for high-risk PCI using contemporary best practices. He describes how the patients in PROTECT III were older with more comorbidities and more complex lesions, and that they underwent more extensive revascularization than patients in the PROTECT II RCT. Yet, 90-day MACCE rates in PROTECT III were improved compared to PROTECT II, and the procedural outcomes in PROTECT III showed improved in-hospital safety with significantly fewer vascular bleeding complications compared to PROTECT II. Looking at in-hospital outcomes, Dr. O’Neill emphasizes that they reflect where the field has been over the last 10 years with “more complete revascularization with improvement in procedural safety.”

Gregg Stone, MD, the primary investigator for PROTECT IV, discusses this ongoing randomized controlled trial that is now recruiting patients. With only 2 prior randomized trials of MCS in high-risk PCI (BCIS-1 and PROTECT II), and very little in clinical guidelines regarding the use of MCS for high-risk PCI, PROTECT IV, according to Dr. Stone, “is really going to be a large-scale, landmark effort.” The hypothesis of the trial is that by providing hemodynamic stability during high-risk, complex PCI, Impella heart pump will facilitate improved stent optimization and more complete revascularization that will translate into improved early and late outcomes. “And we hope to bring you,” Dr. Stone concludes, “in several years, the results of the pivotal PROTECT IV trial.”

Cindy Grines, MD, FACC, MSCAI, presents data from several sources supporting the efficacy of extensive or complete revascularization with Impella in patients with multivessel CAD. She summarizes her presentation stating, “I think that we really should strive for complete and protected revascularization to improve the outcomes. We know from the SYNTAX trial… that complete revascularization is better than incomplete. …We have the SMILE trial, randomized trial, which showed that doing a multivessel PCI in one stage is better than bringing the patients back at a later date. And then finally… we know that on-pump Protected PCI is better.”

Susie Joseph, MD, a heart failure cardiologist, presents data revealing a large unmet need in the assessment of ischemia as a cause or burden for heart failure. While coronary artery disease is the most common cause of heart failure in the United States, she describes a 2016 paper published in JACC reporting that of 81 million patient cases in a database, “astonishingly, within the index hospitalization, or 90 days following, only 67,000 patients were tested either non-invasively or invasively for coronary artery disease.” After walking through more data, Dr. Joseph concludes, “Evaluation is way underutilized. And it astonishes me every day.”

The session concludes with a panel discussion in which Dr. Wollmuth discusses single-access Impella procedures; Dr. Grines talks about SCAI training efforts; Dr. Stone talks about the Surgical Treatment for Ischemic Heart Failure (STICH) trial; and Dr. Joseph explains that further investigation is required to understand why so few heart failure patients are assessed for ischemic disease.