Diabetes and Obesity and Treatment Effect of Early Rhythm Control vs Usual Care in Patients With Atrial Fibrillation: A Secondary Analysis of the EAST-AFNET 4 Randomized Clinical Trial.

However, the impact of body mass index (BMI, calculated as weight in kilograms divided by height in meters squared) and diabetes on outcomes in EAST-AFNET 4 is not known.

然而，EAST-AFNET 4 研究中体质指数（BMI，体重（公斤）除以身高（米）的平方）和糖尿病对结果的影响尚不清楚。

Background

To assess the effects of BMI and diabetes on outcomes in EAST-AFNET 4.

评估体质指数（BMI）和糖尿病对EAST-AFNET 4研究结果的影响。

DESIGN, SETTING, AND PARTICIPANTS: EAST-AFNET 4 is an international, investigator-initiated, parallel-group, open, blinded outcome assessment randomized clinical trial conducted in 11 European countries.

设计、设置和参与者：EAST-AFNET 4是一项国际性的、研究者发起的、平行组、开放标签、结果评估盲法的随机临床试验，在11个欧洲国家进行。

Patients who had early atrial fibrillation (AF, diagnosed ≤1 year before enrollment) and cardiovascular conditions were eligible for inclusion.

符合条件的患者包括早期房颤（AF，入组前诊断≤1年）和心血管疾病患者。

The current analysis is a prespecified secondary analysis of the EAST-AFNET 4 trial performed in the final, locked dataset assigning patients to therapy group on the basis of randomization (intention-to-treatpopulation).

当前分析是EAST-AFNET 4试验的预定次要分析，基于最终锁定的数据集，根据随机分组（意向治疗人群）将患者分配到治疗组。

EAST-AFNET 4 was conducted from June 2010 to May 2020, and this secondary analysis of the final locked data base was performed in 2024.

EAST-AFNET 4研究从2010年6月开展至2020年5月结束，最终锁定数据库的次要分析在2024年完成。

intervention

EAST-AFNET 4 randomly assigned patients to either early rhythm control or usual care.

EAST-AFNET 4研究随机将患者分配到早期节律控制组或常规护理组。

main_outcomes_and_measure

The primary outcome of this analysis and the EAST-AFNET 4 trial is a composite of cardiovascular death, stroke, hospitalization because of heart failure, or acute coronary syndrome.

本分析及EAST-AFNET 4试验的主要结果是心血管死亡、中风、因心力衰竭住院或急性冠状动脉综合征的复合终点。

Results

There were 1086 patients with obesity (BMI ≥30; mean [SD] BMI 34.5 [4.2]) and 1690 patients without obesity (BMI <30; mean [SD] BMI 25.9 [2.6]).

共有1086名肥胖患者（BMI ≥30；平均[标准差]BMI为34.5 [4.2]）和1690名非肥胖患者（BMI <30；平均[标准差]BMI为25.9 [2.6]）。

Overall mean patient age was 70 years, and 1293 patients (46.6%) were female.

患者的平均年龄为70岁，其中1293名患者（占46.6%）为女性。

Patients with obesity were younger (mean [SD] age, 68 [8.6] vs 72 [7.7] years) and had more frequently nonparoxysmal AF patterns (31% vs 24%) than patients without obesity.

肥胖患者比非肥胖患者年轻（平均年龄[标准差]，68[8.6]岁对比72[7.7]岁），且非阵发性房颤的发生率更高（31%对比24%）。

There was no difference in mean (SD) CHA2DS2-VASc score (3.4 [1.3] vs 3.3 [1.3]).

平均（标准差）CHA2DS2-VASc评分无差异（3.4 [1.3] 对比 3.3 [1.3]）。

Obesity did not change the effect of early rhythm control therapy on the first primary outcome (hazard rate point estimates: BMI <30, 0.84; BMI ≥30, 0.69; P for interaction = .22).

肥胖并未改变早期节律控制治疗对第一个主要结果的影响（危险率点估计：BMI <30，0.84；BMI ≥30，0.69；交互作用P值 = .22）。

Patients with diabetes were younger (mean [SD] age, 69 [8.6] vs 71 [8.2] years; P = .001) and had a higher mean CHA2DS2-VASC score (4.06 vs 3.11; P < .001).

糖尿病患者的平均年龄较轻（平均[标准差]年龄，69[8.6]岁对比71[8.2]岁；P=0.001），并且平均CHA2DS2-VASC评分更高（4.06对比3.11；P<0.001）。

Diabetes did not interact with the treatment effect of early rhythm control (diabetes: hazard ratio[HR], 0.77; 95% CI, 0.57-1.05 vs no diabetes: HR, 0.78; 95% CI, 0.64-0.96; P for interaction = .93).

糖尿病与早期节律控制治疗效果无交互作用（糖尿病：风险比[HR]，0.77；95%置信区间[CI]，0.57-1.05对比无糖尿病：HR，0.78；95% CI，0.64-0.96；交互作用P值=0.93）。

There was no difference in safety outcomes between patients with and without diabetes (64 of 351 patients [18.2%] vs 167 of 1039 patients [16.1%]; P for interaction = .99).

在有无糖尿病的患者之间，安全结果没有差异（351名患者中有64名[18.2%]与1039名患者中有167名[16.1%]；交互作用的P值为.99）。

conclusions_and_relevance

This secondary analysis of the EAST-AFNET 4 randomized clinical trial shows that early rhythm control therapy retains its effectiveness and safety in patients with and without diabetes and patients with and without obesity.

这是对EAST-AFNET 4随机临床试验的次要分析，显示早期节律控制治疗在有无糖尿病以及有无肥胖的患者中保持其有效性和安全性。

trial_registration

ClinicalTrials.gov Identifier: NCT01288352.

临床试验注册号：NCT01288352。