OPTIMUM: Does PCI Improve Outcomes in High-Risk Patients Deemed Ineligible For CABG?

With an increasing number of patients with complex left main and/or multivessel coronary disease deemed surgically ineligible for CABG, findings from the OPTIMUM trial presented at TCT 2021 suggest PCI has the potential to improve patients' symptom burden, physical function and quality of life.

The study, led by David E. Kandzari, MD, FACC; Adam C. Salisbury, MD, FACC; and J. Aaron Grantham, MD, FACC, enrolled 750 adult patients from 22 centers in the U.S. who were deemed by the heart team to be ineligible for coronary bypass surgery. Of these, 726 underwent PCI, while 24 were assigned medical therapy.

The majority of patients in the study were over 70 years of age and 31.5% were female. At baseline, more than half (56.6%) of patients had diabetes mellitus, while 48.2% had a prior myocardial infarction, and 32.8% had undergone prior PCI. Other characteristics included, prior CABG (16.4%), current smoking (18.2%), chronic kidney disease (37.2%), atrial fibrillation (23.1%) and class III/IV heart failure (23.4%). Risk characteristics and reasons for surgical ineligibility varied, with poor distal target/conduit (18.9%), severe LV dysfunction/non-viable myocardium (16.8%) and severe lung disease (10.1) ranking highest, followed by frailty, poor sternotomy, advanced age and other factors.

Overall findings from the study found PCI was associated with "significant, meaningful improvements" in patients' reported health status, as well as 30-day in-hospital mortality rates. According to Kandzari and colleagues, these findings highlight the potential of revascularization in this high-risk patient group, provided it can be performed safely, even if surgery is not an option.

They also noted their findings underscore the complex clinical profiles and high disease burden of this specific patient population – factors that are incompletely represented in current surgical prediction models. Looking ahead, the researchers suggest the OPTIMUM study findings are among the only data currently available on health status outcomes following PCI procedures and could be used to help inform future guidance on decision-making in complex coronary disease in this patient group.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Aortic Surgery

Keywords: Transcatheter Cardiovascular Therapeutics, TCT21, Percutaneous Coronary Intervention, Coronary Artery Bypass


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