Clinical Research & Data, Protected PCI
TCT 2022: OPTIMUM Study Sub-Analysis Results
In his TCT 2022 presentation of the preliminary results from the OPTIMUM study, Adam C. Salisbury, MD, MSc, explores the question: What is the association between prophylactic use of Impella® (“Protected PCI”) and clinical outcomes?
The goal of the observational OPTIMUM study, Salisbury explains, was to better describe the frequency of use, patient characteristics, clinical outcomes, and health status of surgical turndown patients undergoing PCI with mechanical circulatory support (MCS). OPTIMUM looked at 726 patients treated with PCI with left main or multivessel coronary disease in 22 US centers. These patients were declared prohibitive risk by the heart team and treated with PCI, with or without Impella support, with the extent of revascularization at the discretion of the operator.
Analysis of the OPTIMUM data requires understanding why MCS was used. “This is about the strategy of the operator,” Salisbury emphasizes. He explains that they—with significant help from Taishi Hirai, MD—did a detailed review of source documents to identify the clinical rationale for MCS use. “Since our focus was on planned mechanical circulatory support to facilitate PCI, we actually reviewed each case to identify the timing of insertion, whether the use was planned, pre-interventions support versus whether this is a patient who’s already in clinical shock.”
Dr. Salisbury explains that observational investigations can struggle to identify the real association between MCS use and outcomes. The OPTIMUM results show higher in-hospital and long-term mortality in patients treated with MCS. “But as you break these patients out by what is the strategy of the operator, you very clearly see that clinical shock or bailout is driving the poor outcomes… So indeed, the mechanical circulatory support outcomes in observational studies are really strongly confounded by critically ill patients with shock and bailout use. And despite much more complicated clinical profiles, prophylactic Impella use had similar outcomes to patients who did not receive support. And although this is a small study, I think it really helps to break out some of these important granular differences.”
Improvement in patient-reported health status was another important goal of the OPTIMUM study. “These are often very complex patients who are most focused on how they feel,” states Dr. Salisbury. OPTIMUM data demonstrated that surviving patients treated with prophylactic MCS, despite having more complex clinical profiles, gained similar long-term health status improvement to those not treated with MCS.