Clinical Research & Data, Complete Revascularization, AMI Cardiogenic Shock, Protected PCI
Contemporary Landscape of PCI and RESTORE EF
At TCT 2019, Ehtisham Mahmud, MD, gave a short, information-packed presentation on the landscape of contemporary PCI, culminating in the introduction of the RESTORE EF study. Dr. Mahmud is director of interventional cardiology at the University of California, San Diego, and at the time of the presentation was the president of the Society for Cardiovascular Angiography & Intervention (SCAI).
Dr. Mahmud opens his presentation with this message for interventional cardiologists: “If we’re going to tackle complex disease, multivessel disease, left ventricular dysfunction, and achieve outcomes that are comparable to bypass surgery, we need to improve our game.”
Dr. Mahmud tells us that nearly 1 million PCI procedures are performed annually in the United States. He then describes particular areas for improvement in quality for PCI:
- In patients with left-main or multivessel disease—approximately ¼ of the nearly 1 million annual PCIs—45% have incomplete revascularization (IR)
- 14% of PCI patients are staged—and not all patients scheduled for staged revascularization return for a second procedure
- 7% of PCI patients suffer from acute kidney injury (AKI)
- 8% to 17% of patients are readmitted within 30 days of PCI procedure for cardiovascular issues with 25% of patients readmitted within 6 months post PCI
- 17% of patients undergoing PCI have AMI cardiogenic shock or other forms of shock
Dr. Mahmud then asks, when we look at the landscape of contemporary PCI, how we can get better outcomes in this large portion of the population with complex disease and complex comorbidities and will ejection fraction and heart failure improve in these patients?
To answer these questions, he presents data from the PROTECT II study showing that the Impella® heart pump is associated with reduced MACCE in more complete revascularization—a 44% reduction at 90 days in patients with 2 or 3 vessels treated. In addition, PROTECT II demonstrates a 22% improvement in LVEF at 90 days post-PCI as well as a 59% reduction in NYHA class III and IV status at 90 days post PCI.
Dr. Mahmud presents data from the US Impella Registry, PROTECT I, PROTECT II, and the Roma-Verona Registry, demonstrating LVEF improvement in high-risk patients at discharge, at 30 days, at 90 days, and at 180 days. In particular, he notes the significant improvement in LVEF at 6-month follow-up in the Roma-Verona Registry where only 22% of patients had LVEF ≥35% at baseline and at 6-month follow-up, 67% of patients had LVEF ≥35%, an increase associated with more complete revascularization.
Dr. Mahmud concludes his presentation by introducing the RESTORE EF study, a multicenter, single-arm, prospective clinical study designed to validate best practices with regard to complete revascularization in a single setting, AKI reduction, atherectomy, and large bore access techniques. Among the exploratory, pre-specified analyses in this study, he notes that a question of particular importance to him is whether baseline myocardial viability is predictive of improvement in outcomes.
Dr. Mahmud summarizes the goal of RESTORE EF as “to take experienced operators, doing at least 300 PCIs on average a year, at centers doing 700 PCIs a year, who are very comfortable and adept at treating patients with multivessel, unprotected left main, using concomitant atherectomy as needed, so that we can find out when you have experienced, well-trained operators who can achieve complete revascularization, can we then translate that to improvement in clinical symptomatology in these very sick patients in 2019 and beyond.”