Effectiveness and Safety of Early Rhythm Control in Patients With Atrial Fibrillation and Chronic Kidney Disease.

The safety and efficacy of early rhythm control (ERC) in patients with CKD is not fully established.

早期节律控制（ERC）在慢性肾脏病（CKD）患者中的安全性和有效性尚未完全确立。

This predefined secondary analysis of the EAST-AFNET 4 trial assessed the effectiveness and safety of ERC in patients with CKD defined by estimated glomerular filtration rate (GFR).

这项预先定义的EAST-AFNET 4试验的次要分析评估了在根据估算的肾小球滤过率（GFR）定义的慢性肾脏病（CKD）患者中，早期复律治疗（ERC）的有效性和安全性。

Methods

EAST-AFNET 4 randomized patients with recently diagnosed AF and comorbidities to ERC or usual care (UC).

EAST-AFNET 4试验将近期诊断为房颤且伴有合并症的患者随机分配到早期复律治疗（ERC）或常规治疗（UC）。

Key outcomes were analyzed by Kidney Disease Improving Global Outcomes defined CKD groups.

主要结果通过肾脏病改善全球预后定义的慢性肾脏病(CKD)组进行分析。

The primary efficacy outcome combined cardiovascular death, stroke, hospitalization for worsening heart failure, or acute coronary syndrome.

主要疗效结果是心血管死亡、中风、因心力衰竭恶化住院或急性冠状动脉综合征的综合。

The safety outcome combined death, stroke, and serious rhythm control-related adverse events.

安全性结果包括死亡、中风以及严重的心律控制相关不良事件。

Recurrent AF was a secondary outcome.

复发性房颤是次要结果。

Results

Baseline creatinine was available in 2,742 of 2,789 (98.3%) patients.

在2,789名患者中，有2,742名（98.3%）患者的基线肌酐数据可用。

In this study, 23% had CKD (GFR: <60 mL/min/1.73 m2).

在这项研究中，23%的患者患有慢性肾脏病（GFR: <60 mL/min/1.73 m2）。

Patients with CKD were older (CKD: 74 ± 7.4 years; no CKD: 69 ± 8.3 years; P < 0.001), had higher CHA2DS2-VASc scores (CKD: 4 ± 1.4; no CKD: 3.2 ± 1.2; P < 0.001), and more primary outcome events over 5.1 years of follow-up (HR: 0.98 per mL GFR decrease [95% CI: 0.97-0.99 per mL GFR decrease]).

慢性肾脏病（CKD）患者的年龄较大（CKD：74 ± 7.4岁；无CKD：69 ± 8.3岁；P < 0.001），CHA2DS2-VASc评分较高（CKD：4 ± 1.4；无CKD：3.2 ± 1.2；P < 0.001），并且在5.1年的随访期间，主要结局事件更多（HR：每减少1mL GFR，风险降低0.98 [95% 置信区间: 每减少1mL GFR，0.97-0.99]）。

ERC reduced the primary outcome with and without CKD (no CKD: ERC: 3.4%/100 patient-years; UC: 4.1%/100 patient-years; HR: 0.84; P < 0.001; CKD: ERC: 5.8%/100 patient-years; UC: 8.5%/100 patient-years; HR: 0.67; P < 0.001; Pinteraction = 0.133).

无论是否存在慢性肾脏病（CKD），ERC治疗均能降低主要结局事件的发生率（无CKD：ERC：3.4%/100患者年；UC：4.1%/100患者年；HR：0.84；P < 0.001；CKD：ERC：5.8%/100患者年；UC：8.5%/100患者年；HR：0.67；P < 0.001；Pinteraction = 0.133）。

CKD increased safety outcomes without interaction with ERC (Pinteraction = 0.927).

慢性肾脏病（CKD）增加了安全性结果，与早期再灌注策略（ERC）无交互作用（Pinteraction = 0.927）。

Patients with CKD experienced more AF recurrences with UC (Pinteraction = 0.036).

患有慢性肾脏病（CKD）的患者在使用尿激酶（UC）时经历了更多的房颤复发（Pinteraction = 0.036）。

Conclusions

ERC effectively and safely reduces cardiovascular events in patients with recently diagnosed AF and stroke risk factors with and without CKD.

ERC 有效地且安全地减少了新近诊断为房颤且具有中风风险因素的患者（无论是否患有慢性肾脏病）的心血管事件。

(Early Treatment of Atrial Fibrillation for Stroke Prevention Trial (EAST); NCT01288352).

(早期房颤治疗以预防中风试验 (EAST); NCT01288352).