爱尔兰国立大学Patrick W Serruys团队开发和验证了SYNTAX II 2020评分系统，可针对复杂冠状动脉疾病患者进行个性化决策，帮助其选择最佳治疗方案。2020年10月8日，该研究发表在《柳叶刀》杂志上。

随机对照试验被认为是检验新型治疗措施疗效的金标准，通常将平均治疗效果作为总结结果来报告。由于不同患者的治疗效果可能不同，因此根据总体平均疗效为个别患者制定治疗策略可能不是最佳选择。研究组旨在开发一种个性化决策工具，以帮助复杂冠状动脉疾病患者选择最佳血运重建策略。

研究组于2005年3月至2007年4月在北美和欧洲18个国家的85家医院进行了一项多中心、随机对照试验（SYNTAXES），招募冠脉三支病变和左主干病变患者，将其按1：1随机分组，分别接受经皮冠状动脉介入治疗（PCI）或冠状动脉搭桥术（CABG）。SYNTAXES研究确定了10年全因死亡率。

研究组使用Cox回归来制定可预测10年内死亡的临床预后指标，并在第二阶段将其与指定的治疗方法（PCI或CABG）和两个预先指定的疗效调节因子（根据疾病类型和解剖SYNTAX评分来确定）相结合。研究组使用类似技术来开发模型，以预测接受PCI或CABG的患者发生重大不良心血管事件（定义为全因死亡、非致命性中风或非致命性心肌梗死的综合结局）的5年风险，之后通过交叉验证，来评估这些模型预测死亡或重大心血管不良事件风险的效果及其差异。

在交叉验证中，新开发的SYNTAX评分II（SYNTAX II 2020）在两个治疗组中均显示了有助于预测10年全因死亡和5年重大不良心血管事件的判别能力。在外部验证中，SYNTAX II 2020评分显示出有效的判别能力，并能很好地预测5年重大不良心血管事件。在试验人群中，CABG相对于PCI，治疗获益的预测差异很大，且获益预测得到了很好的校正。

研究结果表明，预测10年死亡和5年重大心血管不良事件的SYNTAX II 2020评分有助于确定哪些患者将受益于CABG或PCI，从而支持心脏团队、患者及其家属选择最佳的血运重建策略。

附：英文原文

Title: Redevelopment and validation of the SYNTAX score II to individualise decision making between percutaneous and surgical revascularisation in patients with complex coronary artery disease: secondary analysis of the multicentre randomised controlled SYNTAXES trial with external cohort validation

Author: Kuniaki Takahashi, Patrick W Serruys, Valentin Fuster, Michael E Farkouh, John A Spertus, David J Cohen, Seung-Jung Park, Duk-Woo Park, Jung-Min Ahn, Arie Pieter Kappetein, Stuart J Head, Daniel JFM Thuijs, Yoshinobu Onuma, David M Kent, Ewout W Steyerberg, David van Klaveren

Issue&Volume: 2020-10-08

Abstract:

Background

Randomised controlled trials are considered the gold standard for testing the efficacy of novel therapeutic interventions, and typically report the average treatment effect as a summary result. As the result of treatment can vary between patients, basing treatment decisions for individual patients on the overall average treatment effect could be suboptimal. We aimed to develop an individualised decision making tool to select an optimal revascularisation strategy in patients with complex coronary artery disease.

Methods

The SYNTAX Extended Survival (SYNTAXES) study is an investigator-driven extension follow-up of a multicentre, randomised controlled trial done in 85 hospitals across 18 North American and European countries between March, 2005, and April, 2007. Patients with de-novo three-vessel and left main coronary artery disease were randomly assigned (1:1) to either the percutaneous coronary intervention (PCI) group or coronary artery bypass grafting (CABG) group. The SYNTAXES study ascertained 10-year all-cause deaths. We used Cox regression to develop a clinical prognostic index for predicting death over a 10-year period, which was combined, in a second stage, with assigned treatment (PCI or CABG) and two prespecified effect-modifiers, which were selected on the basis of previous evidence: disease type (three-vessel disease or left main coronary artery disease) and anatomical SYNTAX score. We used similar techniques to develop a model to predict the 5-year risk of major adverse cardiovascular events (defined as a composite of all-cause death, non-fatal stroke, or non-fatal myocardial infarction) in patients receiving PCI or CABG. We then assessed the ability of these models to predict the risk of death or a major adverse cardiovascular event, and their differences (ie, the estimated benefit of CABG versus PCI by calculating the absolute risk difference between the two strategies) by cross-validation with the SYNTAX trial (n=1800 participants) and external validation in the pooled population (n=3380 participants) of the FREEDOM, BEST, and PRECOMBAT trials. The concordance (C)-index was used to measure discriminative ability, and calibration plots were used to assess the degree of agreement between predictions and observations.

Findings

At cross-validation, the newly developed SYNTAX score II, termed SYNTAX score II 2020, showed a helpful discriminative ability in both treatment groups for predicting 10-year all-cause deaths (C-index=0·73 [95% CI 0·69–0·76] for PCI and 0·73 [0·69–0·76] for CABG) and 5-year major adverse cardiovascular events (C-index=0·65 [0·61–0·69] for PCI and C-index=0·71 [0·67–0·75] for CABG). At external validation, the SYNTAX score II 2020 showed helpful discrimination (C-index=0·67 [0·63–0·70] for PCI and C-index=0·62 [0·58–0·66] for CABG) and good calibration for predicting 5-year major adverse cardiovascular events. The estimated treatment benefit of CABG over PCI varied substantially among patients in the trial population, and the benefit predictions were well calibrated.

Interpretation

The SYNTAX score II 2020 for predicting 10-year deaths and 5-year major adverse cardiovascular events can help to identify individuals who will benefit from either CABG or PCI, thereby supporting heart teams, patients, and their families to select optimal revascularisation strategies.

DOI: 10.1016/S0140-6736(20)32114-0

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32114-0/fulltext