糖尿病患者经皮冠状动脉介入治疗vs冠状动脉旁路移植术。

IF 14.8 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JAMA cardiology Pub Date : 2025-03-12 DOI:10.1001/jamacardio.2025.0095

Kuniaki Takahashi, Hisao Otsuki, Frederik M Zimmermann, Victoria Y Ding, Thomas Engstrøm, Hans Gustav Hørsted Thyregod, Branko Beleslin, Svetozar Putnik, Luke Tapp, Thomas Barker, Simon Redwood, Christopher Young, G Jan-Willem Bech, Gerard J F Hoohenkerk, Bernard De Bruyne, Nico H J Pijls, William F Fearon

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引用次数: 0

摘要

重要性：与冠状动脉旁路移植术（CABG）相比，糖尿病患者在分流储备（FFR）引导下使用当代药物洗脱支架（DES）经皮冠状动脉介入治疗（PCI）的结果尚不清楚。目的：根据糖尿病患者3年主要心脑血管不良事件（MACCE）情况，探讨PCI与CABG的相对治疗效果，并评价SYNTAX评分的影响。设计、环境和参与者：这是FAME （Fractional Flow Reserve vs Angiography for Multivessel Evaluation）试验的预先指定的亚组分析，FAME是一项研究者发起的、在全球48个中心进行的随机临床试验。FAME 3试验招募了2014年8月至2019年12月期间接受冠状动脉重建术的非左主干三支冠状动脉疾病患者。数据分析于2023年8月进行。临床随访分别在出院时、随机分组后1个月、6个月、1年、2年和3年进行。干预：ffr引导PCI +当前代DES或CABG。主要结局和指标：主要终点为MACCE，定义为3年时全因死亡、心肌梗死、卒中或重复血运重建的综合情况。结果：入组的1500例患者中，平均（SD）年龄为65.1（8.4）岁，265例（17.7%）为女性。FAME 3试验包括428例糖尿病患者（28.5%）。糖尿病患者，尤其是接受胰岛素治疗的患者，在3年时发生MACCE的风险高于非糖尿病患者。在相对治疗效果方面，两例糖尿病患者在ffr引导下行PCI后发生MACCE的风险均高于CABG(风险比[HR]， 1.44；95% ci, 0.91-2.28；P = .12)和非糖尿病患者(HR, 1.50；95% ci, 1.08-2.07；P = .02)，无显著相互作用（相互作用P = .94）。结论和相关性：在FAME 3随机临床试验的亚组分析中，在有糖尿病和无糖尿病的患者中，CABG与ffr引导的PCI相比的相对获益相似。试验注册：ClinicalTrials.gov标识符：NCT02100722。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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FFR-Guided Percutaneous Coronary Intervention vs Coronary Artery Bypass Grafting in Patients With Diabetes.

Importance: Outcomes in patients with diabetes after fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) using current-generation drug-eluting stents (DES) compared with coronary artery bypass grafting (CABG) are unknown.

Objectives: To investigate the relative treatment effect of PCI vs CABG according to diabetes status with respect to major adverse cardiac and cerebrovascular events (MACCE) at 3 years and to evaluate the impact of the SYNTAX score.

Design, setting, and participants: This is a prespecified subgroup analysis of the FAME (Fractional Flow Reserve vs Angiography for Multivessel Evaluation) 3 trial, an investigator-initiated, randomized clinical trial conducted at 48 centers worldwide. The FAME 3 trial enrolled patients with 3-vessel coronary artery disease not involving the left main undergoing coronary revascularization between August 2014 and December 2019. Data analysis was conducted in August 2023. Clinical follow-up was performed at hospital discharge and at 1 month, 6 months, 1 year, 2 years, and 3 years after randomization.

Intervention: Either FFR-guided PCI with current-generation DES or CABG.

Main outcomes and measures: The primary end point was MACCE, defined as the composite of all-cause death, myocardial infarction, stroke, or repeat revascularization at 3 years.

Results: Of 1500 total patients enrolled, mean (SD) patient age was 65.1 (8.4) years, and 265 patients (17.7%) were female. The FAME 3 trial included 428 patients with diabetes (28.5%). Patients with diabetes, especially those receiving insulin, had a higher risk of MACCE at 3 years compared with those without diabetes. Regarding relative treatment effect, the risk of MACCE was higher after FFR-guided PCI compared with CABG in both patients with diabetes (hazard ratio [HR], 1.44; 95% CI, 0.91-2.28; P = .12) and those without diabetes (HR, 1.50; 95% CI, 1.08-2.07; P = .02), with no significant interaction (P for interaction = .94). In patients with a low SYNTAX score (<23), there was no significant difference in MACCE between PCI and CABG, while in patients with an intermediate to high SYNTAX score (≥23), PCI had a higher risk of MACCE than CABG, regardless of diabetes status.

Conclusions and relevance: In this subgroup analysis of the FAME 3 randomized clinical trial, the relative benefit of CABG compared with FFR-guided PCI was similar among patients with and without diabetes.

Trial registration: ClinicalTrials.gov Identifier: NCT02100722.

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来源期刊

JAMA cardiology Medicine-Cardiology and Cardiovascular Medicine

CiteScore

45.80

自引率

1.70%

发文量

264

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