Kim Daehoon, Yang Pil-Sung, You Seng Chan, Jang Eunsun, Yu Hee Tae, Kim Tae-Hoon, Pak Hui-Nam, Lee Moon-Hyoung, Lip Gregory Y H, Sung Jung-Hoon, Joung Boyoung
Division of Cardiology, Department of Internal Medicine, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea (D.K., E.J., H.T.Y., T.H.K., H.N.P., M.H.L., B.J.).
Department of Cardiology, CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea (P.S.Y., J.H.S.).
Ann Intern Med. 2022 Oct;175(10):1356-1365. doi: 10.7326/M21-4798. Epub 2022 Sep 6.
Rhythm control is associated with lower risk for adverse cardiovascular outcomes compared with usual care among patients recently diagnosed with atrial fibrillation (AF) with a CHADS-VASc score of approximately 2 or greater in EAST-AFNET 4 (Early Treatment of Atrial Fibrillation for Stroke Prevention Trial).
To investigate whether the results can be generalized to patients with low stroke risk.
Population-based cohort study.
Nationwide claims database of the Korean National Health Insurance Service.
54 216 patients with AF having early rhythm control (antiarrhythmic drugs or ablation) or rate control therapy that was initiated within 1 year of the AF diagnosis.
The effect of early rhythm control on the primary composite outcome of cardiovascular death, ischemic stroke, hospitalization for heart failure, or myocardial infarction was compared between eligible and ineligible patients for EAST-AFNET 4 (CHADS-VASc score, approximately 0 to 1) using propensity overlap weighting.
In total, 37 557 study participants (69.3%) were eligible for the trial (median age, 70 years; median CHADS-VASc score, 4), among whom early rhythm control was associated with lower risk for the primary composite outcome than rate control (hazard ratio, 0.86 [95% CI, 0.81 to 0.92]). Among the 16 659 low-risk patients (30.7%) who did not meet the inclusion criteria (median age, 54 years; median CHADS-VASc score, 1), early rhythm control was consistently associated with lower risk for the primary outcome (hazard ratio, 0.81 [CI, 0.66 to 0.98]). No significant differences in safety outcomes were found between the rhythm and rate control strategies regardless of trial eligibility.
Residual confounding.
In routine clinical practice, the beneficial association between early rhythm control and cardiovascular complications was consistent among low-risk patients regardless of trial eligibility.
The Ministry of Health and Welfare and the Ministry of Food and Drug Safety, Republic of Korea.
在EAST-AFNET 4(心房颤动早期治疗预防卒中试验)中,与常规治疗相比,节律控制与近期诊断为心房颤动(AF)且CHADS-VASc评分约为2或更高的患者发生不良心血管结局的风险较低相关。
研究这些结果是否可推广至卒中风险较低的患者。
基于人群的队列研究。
韩国国民健康保险服务的全国索赔数据库。
54216例AF患者,在AF诊断后1年内开始进行早期节律控制(抗心律失常药物或消融)或心率控制治疗。
使用倾向重叠加权法,比较符合和不符合EAST-AFNET 4标准(CHADS-VASc评分约为0至1)的患者中,早期节律控制对心血管死亡、缺血性卒中、因心力衰竭住院或心肌梗死的主要复合结局的影响。
共有37557名研究参与者(69.3%)符合试验条件(中位年龄70岁;中位CHADS-VASc评分为4),其中早期节律控制与主要复合结局的风险低于心率控制相关(风险比,0.86[95%CI,0.81至0.92])。在16659名不符合纳入标准的低风险患者(30.7%)中(中位年龄54岁;中位CHADS-VASc评分为1),早期节律控制与主要结局的风险始终较低相关(风险比,0.81[CI,0.66至0.98])。无论试验资格如何,节律控制和心率控制策略在安全性结局方面均未发现显著差异。
残余混杂因素。
在常规临床实践中,无论试验资格如何,早期节律控制与心血管并发症之间的有益关联在低风险患者中是一致的。
大韩民国卫生福利部和食品药品安全部。