Clinical Research & Data, Complete Revascularization, Protected PCI
TCT 2021: Primary Results from the OPTIMUM Registry
Adam Salisbury, MD, MSC, co-primary investigator of the prospective OPTIMUM Registry, presents the study’s primary results. “This is really the first prospective study of its kind to examine a growing and very important sub-segment of the complex PCI space; those are the patients who are surgically ineligible.”
“OPTIMUM was designed to be a very representative registry of real-world practice,” Dr. Salisbury explains, “examining what’s going on currently in the treatment of patients who are surgically ineligible at 22 centers across the United States.”
OPTIMUM enrolled patients deemed by a Heart Team to be ineligible for CABG surgery, focusing on 726 patients treated with some degree of percutaneous coronary intervention (PCI). The primary objective was to compare observed to predicted in-hospital mortality using the STS risk score. The study also examined important health status data using the Seattle Angina Questionnaire (SAQ) and Kansas City Cardiomyopathy Questionnaire (KCCQ) and the study looked at the association between completeness of revascularization and clinical outcomes.
“An interesting finding was that their predicted mortality tracked reasonably well with observed 30-day mortality when using the STS and the EuroSCORE, although I think this has to be considered carefully in the context that these risk scores predict mortality with a more morbid procedure,” Dr. Salisbury explains. “However the surgeon’s personal estimates of their mortality risk suggested that they expected a nearly 2-fold higher rate of death after bypass surgery.”
“What I think is really interesting,” Dr. Salisbury emphasizes, “is there was a profound improvement in patients’ health status after the treatments percutaneously. Comparing baseline to 6-month health status scores you see statistically and, more important, clinically significant improvements in each domain of the Seattle Angina Questionnaire, particularly angina frequency and quality of life, and also a very robust improvement in heart failure symptoms as evidenced by the KCCQ scores.”
In addition, he explains, “there was a trend towards reduction in early mortality among patients who were treated with complete revascularization during their procedures.” While these results were gleaned from relatively small numbers and were not statistically significant, there was, he explains, a numerically significant difference between those who achieved a SYNTAX score of 8 or less and those who had more incomplete revascularization.
In summary, Dr. Salisbury states that PCI was associated with “very significant and meaningful improvements in symptom burden, physical function, and quality of life, and I think this underscores the potential for revascularization to improve patients’ symptoms and we really look forward to some further analyses of this really unique study.”