OPTIMUM: Outcomes of Percutaneous RevascularizaTIon for Management of SUrgically Ineligible Patients with Multivessel or Left Main Coronary Artery Disease
Reported from TCT 2021
Mirvat Alasnag reviews the OPTIMUM trial, presented by David E. Kandzari, which reports outcomes in a subset of patients who are increasingly seen in modern day catheterization laboratories. It is noteworthy that 1 in 5 patients with left main or multivessel disease are considered surgically ineligible.
Public reporting of outcomes and physician metrics along with a growing CHIP (Complex high risk indicated Percutaneous coronary interventions (PCI)) momentum are only a few justifications for this study. The most important, however, is that these patients remain symptomatic and the evidence and guidance for outcomes of PCI are lacking.
Patient population
Approximately 750 patients across 22 centers in the United States were recruited in the OPTIMUM study. Those were individuals deemed inoperable at the heart team meeting and therefore declined coronary bypass surgery (CABG). PCI was performed in 726 with the remaining 24 receiving optimal medical therapy alone. The reasons the heart team considered them high risk included the following:
- 16.8% had severe left ventricular dysfunction or nonviable myocardium on imaging
- 18.9% had poor distal targets
- 16.8% had advanced lung disease
- 10.1% were reportedly frail and/or advanced age
Primary and secondary objectives
The primary objective was 30-day and in-hospital mortality in PCI cohort compared with predicted Society of Thoracic Surgeons (STS) surgical risk. The secondary objectives included the 30-day and in-hospital mortality in PCI cohort compared with the EuroSCORE II and the Surgeon’s predicted risk. Quality of life assessment was also reported as well as the completeness of the revascularization.
Inclusion and exclusion criteria
The inclusion criteria were as follows:
- Age ≥ 18 years
- Unprotected left main stenosis of ≥50%
- 3 vessel disease (stenoses ≥70%) or 2 vessel coronary disease (≥70%) with one lesion involving the proximal left anterior descending artery
- Prior bypass surgery: ≥2 epicardial coronary distributions subtended by a severe native coronary stenosis with either no bypass graft supplying the vessel, a severely diseased (≥70% angiographic stenosis) bypass graft supplying the affected vessel
- Heart Team determination for CABG ineligibility
There were few exclusion criteria, namely, ST elevation myocardial infarction, ventricular arrhythmia or hemodynamic instability or an expected survival of less than one year.
Source : Mirvat Alasnag
A very high risk population with complex disease and comorbid conditions
The baseline characteristics of the study cohort indicate a very high risk population with complex disease and comorbid conditions. The mean age was over 70 years of age, 31.5% of whom were women. Over half (56.6%) had diabetes mellitus, 48.2% had a prior myocardial infarction (MI), and 32.8% had a prior PCI and 16.4% had a prior CABG (16.4%). Chronic kidney disease was reported in 37.2%, atrial fibrillation in 23.1%, class III-IV heart failure in 23.4% and stroke was 13.8%. Interestingly, the mean ejection fraction was 42%, that is, only moderately reduced.
Not only was the patient population high risk, but the coronary anatomy was complex with 82% having heavy calcification, 80% bifurcations, 56.9% chronic total occlusion and 45.3% with a high Syntax Score of more than 33. Left main disease was noted in 38.2% and mechanical circulatory support was employed in 27% only. Contrary to common belief, it appears MCS is not overused in the United States. Unlike other studies presented at TCT, intravascular imaging was used in 63.9%. Complications were reported in 9.8%.
Highlighting the failure of predictive models?
This study highlighted the failure of many predictive models in capturing the true risk of such a population. The STS predicted mortality was 5.3 and the EuroSCORE II predicted mortality was 5.7; however, the surgeon’s prediction was 10.4 (significantly higher). The observed 30-day and in-hospital mortality in this population was 5.6. More importantly, PCI was associated with a significant improvement in patients' reported health status. With respect to complete revascularization, the study noted a trend to better in-hospital/30-day mortality and 6-month health status in those with a lower residual Syntax Score.
The central role of the heart team
The reported lower frequency of angina, improvement in overall quality of life and reduction in in-hospital/30-day mortality rates suggest there is room for high-risk PCI in patients with no other options and this procedure is in fact safe. The role of the heart team in adequately evaluating, predicting risk and strategizing is central to the safety of CHIP. The only remaining question is whether this single study suffices to change guidelines to include CHIP for patients with prohibitive risk.
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