Erasmus University Medical Center, Rotterdam, The Netherlands.
EuroIntervention. 2017 Mar 20;12(16):2001-2008. doi: 10.4244/EIJ-D-16-00612.
The aim of this study was to investigate whether a Heart Team decision-making process regarding the choice of revascularisation strategy based on non-invasive coronary multislice computed tomography angiography (MSCT) assessment of coronary artery disease (CAD) is equivalent to the standard-of-care invasive angiography-based assessment in patients with multivessel CAD.
The SYNTAX III Revolution trial is a prospective, multicentre, all-comers randomised trial that will randomise two Heart Teams to select between surgical and percutaneous treatment according to either an invasive conventional angiography or a non-invasive MSCT angiography assessment in patients with multivessel CAD. The treatment selection by each Heart Team will be guided by the SYNTAX score II calculation. The primary endpoint is the level of agreement according to kappa of the initial decision by the Heart Teams on the modality of the revascularisation based on MSCT and angiography assessments. Secondary endpoints include agreement on the number of vessels requiring treatment and the coronary segments in need of revascularisation.
The SYNTAX III Revolution trial will provide valuable information regarding the ability of a purely non-invasive coronary anatomy assessment to select accurately the most appropriate revascularisation strategy for patients with multivessel CAD.
本研究旨在探讨基于非侵入性冠状动脉多层螺旋 CT 血管造影术（MSCT）评估冠状动脉疾病（CAD）的心脏团队决策制定过程在多支血管 CAD 患者中的血运重建策略选择方面是否等同于标准的基于侵入性血管造影的评估。
SYNTAX III Revolution 试验是一项前瞻性、多中心、所有患者均可参加的随机试验，将随机将两个心脏团队分为两组，根据多支血管 CAD 患者的侵入性常规血管造影或非侵入性 MSCT 血管造影评估，选择手术或经皮治疗。每个心脏团队的治疗选择将根据 SYNTAX 评分 II 计算进行指导。主要终点是根据 Kappa 评估，根据 MSCT 和血管造影评估，心脏团队对血运重建方式的初始决策的一致性水平。次要终点包括对需要治疗的血管数量和需要血运重建的冠状动脉节段的一致性。
SYNTAX III Revolution 试验将提供有关纯粹的非侵入性冠状动脉解剖评估准确选择多支血管 CAD 患者最合适的血运重建策略的能力的有价值信息。
