Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.
Department of Cardiology, Jiangxi Provincial People's Hospital, The First Affiliated Hospital of Nanchang Medical College, Nanchang, Jiangxi, China.
Int J Cardiol. 2024 Oct 1;412:132327. doi: 10.1016/j.ijcard.2024.132327. Epub 2024 Jul 2.
The favorable benefits of early rhythm control (ERC) therapy in newly diagnosed patients with atrial fibrillation (AF) have been demonstrated in the EAST-AFNET 4 trial. However, the generalizability and applicability of ERC in real-world clinical settings remain inconclusive.
We conducted a systematic search of the PubMed and Embase databases to identify observational studies published between January 2020 and February 2024 that focused on real-world evidence pertaining to ERC. The effectiveness and safety outcomes in our study were analogous to those evaluated in the EAST-AFNET 4 trial.
A total of 4 observational studies that fulfilled the inclusion criteria of EAST-AFNET 4 were included, involving 130,970 patients with AF, 30.7% of whom received ERC therapy. In our pooled analysis using the fixed-effects model, compared with rate control, ERC significantly decreased the occurrence risk of the primary composite outcome (hazard ratio [HR] 0.86, 95% confidence interval[CI] 0.82-0.91), cardiovascular death (HR 0.87, 95% CI 0.78-0.98), stroke (HR 0.80, 95% CI 0.73-0.87), and hospitalization with worsening heart failure (HR 0.91, 95% CI 0.84-0.99) or acute coronary syndrome (HR 0.72, 95% CI 0.59-0.87). In terms of safety outcomes, there were no differences in the composite safety outcome (HR 1.00, 95% CI 0.95-1.05) and all-cause death (HR 0.93, 95% CI 0.82-1.06) between the two studied groups.
ERC therapy showed favorable effectiveness outcomes compared with rate control, whereas the safety outcomes between the two therapeutic strategies did not differ significantly, supporting the benefits of ERC therapy over rate control in selected real-world patients with AF.
The study protocol was registered to PROSPERO (CRD42023443569).
EAST-AFNET 4 试验已经证明,在新诊断的心房颤动 (AF) 患者中早期节律控制 (ERC) 治疗的有利益处。然而,在真实临床环境中 ERC 的普遍性和适用性仍不确定。
我们对 PubMed 和 Embase 数据库进行了系统检索,以确定 2020 年 1 月至 2024 年 2 月期间发表的、专注于 ERC 真实世界证据的观察性研究。我们研究中的有效性和安全性结果与 EAST-AFNET 4 试验中评估的结果相似。
共纳入 4 项符合 EAST-AFNET 4 纳入标准的观察性研究,共纳入 130970 例 AF 患者,其中 30.7%接受 ERC 治疗。在使用固定效应模型进行的汇总分析中,与心率控制相比,ERC 显著降低了主要复合结局(风险比 [HR] 0.86,95%置信区间 [CI] 0.82-0.91)、心血管死亡(HR 0.87,95%CI 0.78-0.98)、卒中和因心力衰竭恶化(HR 0.91,95%CI 0.84-0.99)或急性冠状动脉综合征(HR 0.72,95%CI 0.59-0.87)住院的发生风险。在安全性结局方面,两组间复合安全性结局(HR 1.00,95%CI 0.95-1.05)和全因死亡(HR 0.93,95%CI 0.82-1.06)无差异。
与心率控制相比,ERC 治疗显示出良好的疗效结果,而两种治疗策略的安全性结局无显著差异,支持在选定的真实世界 AF 患者中 ERC 治疗优于心率控制。
该研究方案已在 PROSPERO(CRD42023443569)注册。