Saint Luke's Mid America Heart Institute, Kansas City, MO, United States of America; University of Missouri-Kansas City, Kansas City, MO, United States of America.
Columbia University and New York Presbyterian Hospital, New York, NY, United States of America.
Cardiovasc Revasc Med. 2022 Aug;41:83-91. doi: 10.1016/j.carrev.2022.01.008. Epub 2022 Jan 31.
Guidelines endorse coronary artery bypass as the preferred revascularization strategy for patients with left main and/or multivessel coronary artery disease (CAD). However, many patients are deemed excessively high risk for surgery after Heart Team evaluation. No prospective studies have examined contemporary treatment patterns, rationale for surgical decision-making, completeness of revascularization with percutaneous coronary intervention (PCI), and outcomes in this high-risk population with advanced CAD.
We designed the Outcomes of Percutaneous RevascularizaTIon for Management of SUrgically Ineligible Patients with Multivessel or Left Main Coronary Artery Disease (OPTIMUM) registry, a prospective, multicenter study of patients with "surgical anatomy" determined to be at prohibitive risk for bypass surgery. The primary outcome is comparison of observed to predicted 30-day mortality, with secondary outcomes of patient-reported health status and the association between completeness of revascularization and clinical outcomes. Patient characteristics driving surgical risk determinations will be reported, and peri-operative risk will be assessed using validated scoring methods. Angiograms will be assessed by an independent core laboratory, and clinical events will be adjudicated.
Clinical outcomes assessments will include 30-day and 1-year cardiovascular events, health status at 1, 6 and 12-months, and 5-year mortality.
OPTIMUM is the first prospective, multicenter study to examine treatment strategies and outcomes among multivessel CAD patients deemed ineligible for surgical revascularization after Heart Team assessment. This registry will provide unique insights into the clinical decision-making, revascularization practices, safety, effectiveness, and health status outcomes in this high-risk population.
指南支持冠状动脉旁路移植术作为左主干和/或多支冠状动脉疾病（CAD）患者首选的血运重建策略。然而，许多患者在心脏团队评估后被认为手术风险过高。没有前瞻性研究研究过这种高危人群中晚期 CAD 的当代治疗模式、手术决策的理由、经皮冠状动脉介入治疗（PCI）的血运重建完整性和结果。
我们设计了经皮血运重建治疗多支血管或左主干 CAD 手术不适合患者的结果（OPTIMUM）登记研究，这是一项多中心前瞻性研究，纳入了“手术解剖学”被确定为搭桥手术禁忌风险的患者。主要结果是观察到的与预测的 30 天死亡率的比较，次要结果是患者报告的健康状况和血运重建完整性与临床结果之间的关联。将报告驱动手术风险决策的患者特征，并使用经过验证的评分方法评估围手术期风险。将由独立核心实验室评估血管造影，并对临床事件进行裁决。
临床结果评估将包括 30 天和 1 年心血管事件、1、6 和 12 个月的健康状况以及 5 年死亡率。
OPTIMUM 是第一项前瞻性、多中心研究，旨在检查经心脏团队评估后被认为不适合手术血运重建的多支 CAD 患者的治疗策略和结果。该登记研究将为高危人群的临床决策、血运重建实践、安全性、有效性和健康状况结果提供独特的见解。
