伴有高合并症负担的心房颤动患者的早期节律控制。

Early Rhythm Control in Patients With Atrial Fibrillation and High Comorbidity Burden.

机构信息

Department of Cardiology, University Heart and Vascular Center (A.R., K.B., A.M., P.K.), University Medical Center Hamburg-Eppendorf, Germany.

German Center for Cardiovascular Research, Partner Site Hamburg/Luebeck/Kiel, Germany (A.R., K.-H.K., A.M., K.W., P.K.).

出版信息

Circulation. 2022 Sep 13;146(11):836-847. doi: 10.1161/CIRCULATIONAHA.122.060274. Epub 2022 Aug 15.

DOI:10.1161/CIRCULATIONAHA.122.060274

PMID:35968706

Abstract

BACKGROUND

The randomized EAST-AFNET4 (Early Treatment of Atrial Fibrillation for Stroke Prevention Trial-Atrial Fibrillation Network) demonstrated that early rhythm control (ERC) reduces adverse cardiovascular outcomes in patients with recently diagnosed atrial fibrillation and stroke risk factors. The effectiveness and safety of ERC in patients with multiple cardiovascular comorbidities is not known.

METHODS

These prespecified subanalyses of EAST-AFNET4 compared the effectiveness and safety of ERC with usual care (UC) stratified into patients with higher (CHADS-VASc score ≥4) and lower comorbidity burden. Sensitivity analyses ignored sex (CHADS-VA score).

RESULTS

EAST-AFNET4 randomized 1093 patients with CHADS-VASc score ≥4 (74.8±6.8 years, 61% female) and 1696 with CHADS-VASc score <4 (67.4±8.0 years, 37% female). ERC reduced the composite primary efficacy outcome of cardiovascular death, stroke, or hospitalization for worsening of heart failure or for acute coronary syndrome in patients with CHADS-VASc score ≥4 (ERC, 127/549 patients with events; UC, 183/544 patients with events; hazard ratio [HR], 0.64 [0.51-0.81]; < 0.001) but not in patients with CHADS-VASc score <4 (ERC, 122/846 patients with events; UC, 133/850 patients with events; HR, 0.93 [0.73-1.19]; =0.56, =0.037). The primary safety outcome (death, stroke, or serious adverse events of rhythm control therapy) was not different between study groups in patients with CHADS-VASc score ≥4 (ERC, 112/549 patients with events; UC, 132/544 patients with events; HR, 0.84 [0.65, 1.08]; =0.175), but occurred more often in patients with CHADS-VASc scores <4 randomized to ERC (ERC, 119/846 patients with events; UC, 91/850 patients with events; HR, 1.39 [1.05-1.82]; =0.019, =0.008). Life-threatening events or death were not different between groups (CHADS-VASc score ≥4, ERC, 84/549 patients with event, UC, 96/544 patients with event; CHADS-VASc scores <4, ERC, 75/846 patients with event, UC, 73/850 patients with event). When female sex was ignored for the creation of higher and lower risk groups (CHADS-VA score), the was not significant for the primary efficacy outcome (=0.25), but remained significant (=0.044) for the primary safety outcome.

CONCLUSIONS

Patients with recently diagnosed atrial fibrillation and CHADS-VASc score ≥4 should be considered for ERC to reduce cardiovascular outcomes, whereas those with fewer comorbidities may have less favorable outcomes with ERC.

REGISTRATION

URL: https://www.

CLINICALTRIALS

gov; Unique identifier: NCT01288352. URL: https://www.clinicaltrialsregister.eu; Unique identifier: 2010-021258-20. URL: https://www.isrctn.com/; Unique identifier: ISRCTN04708680.

摘要

背景

EAST-AFNET4（早期房颤治疗预防卒中队列-房颤网络）的随机试验表明，近期诊断为房颤且伴有中风危险因素的患者进行早期节律控制（ERC）可降低不良心血管结局。然而，患有多种心血管合并症的患者接受 ERC 的有效性和安全性尚不清楚。

方法

这些 EAST-AFNET4 的预设亚组分析比较了 ERC 与常规护理（UC）在高（CHADS-VASc 评分≥4）和低合并症负担患者中的有效性和安全性。敏感性分析忽略了性别（CHADS-VA 评分）。

结果

EAST-AFNET4 随机纳入了 1093 例 CHADS-VASc 评分≥4（74.8±6.8 岁，61%女性）和 1696 例 CHADS-VASc 评分<4（67.4±8.0 岁，37%女性）的患者。ERC 降低了 CHADS-VASc 评分≥4 的患者的主要复合疗效终点（心血管死亡、中风或心力衰竭恶化或急性冠状动脉综合征的住院治疗）（ERC，549 例患者中有 127 例发生事件；UC，544 例患者中有 183 例发生事件；风险比 [HR]，0.64 [0.51-0.81]；<0.001），但在 CHADS-VASc 评分<4 的患者中则无差异（ERC，846 例患者中有 122 例发生事件；UC，850 例患者中有 133 例发生事件；HR，0.93 [0.73-1.19]；=0.56，=0.037）。在 CHADS-VASc 评分≥4 的患者中，主要安全性结局（死亡、中风或节律控制治疗的严重不良事件）在研究组之间没有差异（ERC，549 例患者中有 112 例发生事件；UC，544 例患者中有 132 例发生事件；HR，0.84 [0.65-1.08]；=0.175），但在 CHADS-VASc 评分<4 的患者中，接受 ERC 的患者发生率更高（ERC，846 例患者中有 119 例发生事件；UC，850 例患者中有 91 例发生事件；HR，1.39 [1.05-1.82]；=0.019，=0.008）。在两组中危及生命的事件或死亡没有差异（CHADS-VASc 评分≥4，ERC，549 例患者中有 84 例发生事件，UC，544 例患者中有 96 例发生事件；CHADS-VASc 评分<4，ERC，846 例患者中有 75 例发生事件，UC，850 例患者中有 73 例发生事件）。当创建更高和更低风险组时忽略女性性别（CHADS-VA 评分），则主要疗效结局的无统计学意义（=0.25），但主要安全性结局仍有统计学意义（=0.044）。