紫杉醇药物洗脱支架与冠状动脉旁路移植术联合应用的经皮冠状动脉介入治疗与外科血管重建术的 10 年生存获益和适宜性随机临床试验

Ten-year survival benefit and appropriateness of surgical versus percutaneous revascularization in synergy between percutaneous coronary intervention with Taxus and cardiac surgery randomized trial.

机构信息

CORRIB Research Centre for Advanced Imaging and Core Laboratory, University of Galway, Galway, Ireland.

Department of Cardiology, Xijing Hospital, Xi'an, Shannxi, China.

出版信息

Eur J Cardiothorac Surg. 2024 Nov 4;66(5). doi: 10.1093/ejcts/ezae391.

OBJECTIVES

Average treatment effects from randomized trials do not reflect the heterogeneity of an individual's response to treatment. This study evaluates the appropriate proportions of patients for coronary artery bypass grafting, or percutaneous intervention based on the predicted/observed ratio of 10-year all-cause mortality in the SYNTAX population.

METHODS

The study included 1800 randomized patients and 1275 patients in the nested percutaneous (n = 198) or surgical (n = 1077) registries. The primary end point was 10-year all-cause mortality. The SYNTAX score II-2020 was validated internally in the randomized cohort and externally in the registry cohort. Proportions of patients with survival benefits from coronary artery bypass grafting or percutaneous intervention were determined using SYNTAX score II-2020.

RESULTS

Ten-year mortality was 23.8% for coronary artery bypass grafting, 28.6% for percutaneous intervention in the randomized cohort, 27.6% for coronary artery bypass grafting and 55.4% for percutaneous intervention in the registries. In the coronary artery bypass grafting registry, the SYNTAX score II-2020 predicted 10-year mortality with helpful calibration and discrimination (C-index: 0.70, intercept: 0.00, slope: 0.76). The proportion of patients deriving a predicted survival benefit from coronary artery bypass grafting over percutaneous intervention was 82.4% (2143/2602) and 17.7% (459/2602) for the entire SYNTAX trial population, translating into a 4.7 to 1 appropriate ratio of treatment allocation to coronary artery bypass grafting and percutaneous intervention.

CONCLUSIONS

Choosing a revascularization modality should depend on an individual's long-term prognosis rather than average treatment effects. Additionally, patients should be informed about their predicted prognosis.

TRIAL REGISTRATION

Registered on clinicaltrial.gov.

SYNTAXES

NCT03417050 (https://clinicaltrials.gov/ct2/show/NCT03417050).

SYNTAX

NCT00114972 (https://www.clinicaltrials.gov/ct2/show/NCT00114972).

目的

随机试验的平均治疗效果不能反映个体对治疗的反应异质性。本研究根据 SYNTAX 人群中 10 年全因死亡率的预测/观察比值，评估冠状动脉旁路移植术或经皮介入治疗的合适患者比例。

方法

该研究纳入了 1800 名随机患者和嵌套的经皮（n=198）或手术（n=1077）注册研究中的 1275 名患者。主要终点为 10 年全因死亡率。SYNTAX 评分 II-2020 在随机队列中进行内部验证，并在注册队列中进行外部验证。使用 SYNTAX 评分 II-2020 确定接受冠状动脉旁路移植术或经皮介入治疗的患者的生存获益比例。

结果

冠状动脉旁路移植术的 10 年死亡率为 23.8%，随机队列中经皮介入治疗的 10 年死亡率为 28.6%，注册队列中冠状动脉旁路移植术的 10 年死亡率为 27.6%，经皮介入治疗的 10 年死亡率为 55.4%。在冠状动脉旁路移植术注册研究中，SYNTAX 评分 II-2020 具有有益的校准和区分度（C 指数：0.70，截距：0.00，斜率：0.76）来预测 10 年死亡率。预测接受冠状动脉旁路移植术治疗比经皮介入治疗有生存获益的患者比例为 82.4%（2143/2602）和 17.7%（459/2602），适用于整个 SYNTAX 试验人群，相当于冠状动脉旁路移植术和经皮介入治疗的治疗分配比例为 4.7:1。