Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.
Institute of Clinical Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan.
Thromb Haemost. 2022 Nov;122(11):1899-1910. doi: 10.1055/a-1807-0336. Epub 2022 Mar 23.
In the Early Treatment of Atrial Fibrillation for Stroke Prevention Trial (EAST-AFNET 4), early rhythm control was associated with better clinical outcomes for patients with atrial fibrillation (AF). However, the intervention arm had more structured and regular follow-up, and whether the better outcomes of patients assigned to rhythm control were solely due to "early" intervention or because of more regular and structured follow-up was unclear.
In the present study, we aimed to investigate whether the findings of the EAST trial are applicable to the "real-world" clinical setting, where a less structured management protocol is operated.
From 2001 to 2016, 301,064 newly diagnosed AF patients were identified from Taiwan National Health Insurance Research Database. Among these patients, 62,649 AF patients receiving antiarrhythmic drugs or catheter ablation within 1 year after AF being diagnosed (similar to the timing definition of the EAST-AFNET 4 trial) were categorized as the early rhythm control group, and the remaining 238,415 patients were defined as usual care group. Risks of clinical events were compared between the two groups.
Compared with usual care, early rhythm control was associated with a lower adjusted risk of ischemic stroke (adjusted hazard ratio [aHR]: 0.771, 95% confidence interval [CI]: 0.751-0.792; < 0.001), heart failure (aHR: 0.851, 95% CI: 0.806-0.899; < 0.001), acute myocardial infarction (aHR: 0.915, 95% CI: 0.877-0.955; < 0.001), mortality (aHR: 0.794, 95% CI: 0.782-0.806; < 0.001), and composite adverse events (aHR: 0.823, 95% CI: 0.813-0.834; < 0.001). Compared with usual care, the lower risks of ischemic stroke (aHR: 0.746, 95% CI: 0.717-0.775), heart failure (aHR: 0.819, 95% CI: 0.798-0.841), mortality (aHR: 0.777, 95% CI: 0.759-0.795), and composite adverse events (aHR: 0.802, 95% CI: 0.787-0.818) associated with early rhythm control were even more evident when performed early (<3 months) compared to later periods (3-6 months, 7-9 months, and 10-12 months; < 0.001). Principal results were generally consistent for majority of subgroups studied and among the cohort after propensity matching.
In this nationwide cohort study, early rhythm control therapy was associated with a lower risk of adverse events compared with usual care among patients with early AF. Outcomes were even better with earlier (<3 months) intervention.
在早期治疗心房颤动预防试验(EAST-AFNET 4)中,早期节律控制与心房颤动(AF)患者的临床结局改善相关。然而,干预组接受了更有结构和规律的随访,分配到节律控制组的患者的更好结局是否仅仅是因为“早期”干预,还是因为更有规律和结构化的随访尚不清楚。
本研究旨在探讨 EAST 试验的结果是否适用于“真实世界”临床环境,即采用不太结构化的管理方案。
2001 年至 2016 年,从台湾全民健康保险研究数据库中确定了 301064 例新诊断的 AF 患者。在这些患者中,62649 例 AF 患者在 AF 确诊后 1 年内接受抗心律失常药物或导管消融治疗(类似于 EAST-AFNET 4 试验的时间定义)被归类为早期节律控制组,其余 238415 例患者被定义为常规护理组。比较两组的临床事件风险。
与常规护理相比,早期节律控制与较低的调整后缺血性卒中风险相关(调整后危险比[aHR]:0.771,95%置信区间[CI]:0.751-0.792; < 0.001)、心力衰竭(aHR:0.851,95%CI:0.806-0.899; < 0.001)、急性心肌梗死(aHR:0.915,95%CI:0.877-0.955; < 0.001)、死亡率(aHR:0.794,95%CI:0.782-0.806; < 0.001)和复合不良事件(aHR:0.823,95%CI:0.813-0.834; < 0.001)。与常规护理相比,早期节律控制与较低的缺血性卒中风险(aHR:0.746,95%CI:0.717-0.775)、心力衰竭(aHR:0.819,95%CI:0.798-0.841)、死亡率(aHR:0.777,95%CI:0.759-0.795)和复合不良事件(aHR:0.802,95%CI:0.787-0.818)相关的风险在早期(<3 个月)干预时比晚期(3-6 个月、7-9 个月和 10-12 个月)更明显 < 0.001)。主要结果在大多数研究亚组和倾向匹配后的队列中基本一致。
在这项全国性队列研究中,与常规护理相比,早期 AF 患者早期节律控制治疗与不良事件风险降低相关。早期(<3 个月)干预的效果更好。