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

Background

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.

研究PCI与CABG根据糖尿病状态对3年主要不良心脏和脑血管事件(MACCE)的相对治疗效果，并评估SYNTAX评分的影响。

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.

这是FAME（冠状动脉血流储备分数与多血管评估的冠状动脉造影比较）3试验的预定亚组分析，这是一项由研究者发起的、在全球48个中心进行的随机临床试验。

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.

FAME 3试验招募了在2014年8月至2019年12月期间接受冠状动脉血运重建的、不涉及左主干的三支血管冠状动脉疾病患者。

Data analysis was conducted in August 2023.

数据分析于2023年8月进行。

Clinical follow-up was performed at hospital discharge and at 1 month, 6 months, 1 year, 2 years, and 3 years after randomization.

临床随访在出院时以及随机化后1个月、6个月、1年、2年和3年进行。

intervention

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

研究对象为采用FFR指导的当前代药物洗脱支架（DES）进行经皮冠状动脉介入治疗（PCI）或冠状动脉旁路移植术（CABG）的患者。

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.

主要终点事件为MACCE，定义为3年时全因死亡、心肌梗死、中风或再次血运重建的复合终点。

Results

Of 1500 total patients enrolled, mean (SD) patient age was 65.1 (8.4) years, and 265 patients (17.7%) were female.

在纳入的1500名患者中，患者的平均年龄为65.1岁（标准差8.4岁），其中265名患者（17.7%）为女性。

The FAME 3 trial included 428 patients with diabetes (28.5%).

FAME 3试验包括了428名糖尿病患者（占28.5%）。

Patients with diabetes, especially those receiving insulin, had a higher risk of MACCE at 3 years compared with those without diabetes.

患有糖尿病的患者，尤其是接受胰岛素治疗的患者，在3年内发生主要不良心脑血管事件（MACCE）的风险较无糖尿病患者更高。

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).

在相对治疗效果方面，糖尿病患者（风险比[HR]，1.44；95%置信区间[CI]，0.91-2.28；P = .12）和无糖尿病患者（HR，1.50；95% CI，1.08-2.07；P = .02）在FFR指导下的经皮冠状动脉介入治疗（PCI）后，主要不良心脑血管事件（MACCE）的风险均高于冠状动脉旁路移植术（CABG），且两组间无显著的相互作用（相互作用P值 = .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.

在SYNTAX评分较低（<23）的患者中，PCI与CABG在主要不良脑血管事件（MACCE）方面没有显著差异，而在中到高SYNTAX评分（≥23）的患者中，无论糖尿病状态如何，PCI的MACCE风险均高于CABG。

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.

在FAME 3随机临床试验的这一亚组分析中，与FFR指导下的PCI相比，CABG对有无糖尿病患者带来的相对益处是相似的。

trial_registration

ClinicalTrials.gov Identifier: NCT02100722.

临床试验注册号：NCT02100722。