Segan Louise, Kistler Peter M, Nanayakkara Shane, Taylor Andrew, Hare James, Costello Benedict, Chieng David, Crowley Rose, William Jeremy, Sugumar Hariharan, Cho Kenneth, Voskoboinik Aleksandr, Ling Liang-Han, Nderitu Ziporah, Azzopardi Sonia, Curtin Annie, Premaratne Manuja, McLellan Alex J, Mariani Justin, Morton Joseph B, Lee Geoffrey, Joseph Stephen, Reid Christopher, Kaye David M, Kalman Jonathan M, Prabhu Sandeep
Department of Cardiometabolics, The Baker Heart and Diabetes Institute, 99 Commercial Rd, Melbourne, VIC 3004, Australia.
Heart Centre at the Alfred Hospital, 55 Commercial Road, Melbourne 3004, Australia.
Eur Heart J. 2025 Aug 12. doi: 10.1093/eurheartj/ehaf563.
Atrial fibrillation-mediated cardiomyopathy (AFCM) represents an important reversible cause of left ventricular systolic dysfunction. Current clinical practice is indefinite heart failure (HF) pharmacotherapy despite left ventricular ejection fraction (LVEF) normalization. However, whether this is necessary to maintain normal LVEF, in addition to rhythm control, is uncertain.
This multi-centre, randomized trial conducted between 2021 and 2024 examined the impact of staged withdrawal of HF therapy following AF rhythm control and LVEF normalization in AFCM. Participants were randomized (1:1) to early withdrawal (Group A) or continued therapy for 6 months followed by delayed withdrawal (Group B), in a crossover design. The primary endpoint was the randomized comparison of cardiac magnetic resonance (CMR) LVEF maintenance ≥50% at 6 months, during which time Group A had withdrawn therapy and Group B remained on treatment. Secondary outcomes included cardiac remodelling, functional status, biomarkers, quality of life, and arrhythmia recurrence on vs off HF therapy. The total follow-up duration was 12 months.
Between July 2021 and May 2024, 60 patients were enrolled (age 60 [55-65] years, previous persistent AF <1 year and maintaining sinus rhythm for minimum 6 months following AF rhythm control [catheter ablation in 97%]). All participants completed treatment withdrawal and 12-month follow-up. In the initial randomized comparison, LVEF was maintained ≥50% at 6 months in 90% of participants undergoing HF therapy withdrawal (Group A), compared with 100% who continued medical therapy (Group B) (odds ratio [OR] 1.18, 95% confidence interval [CI] 0.27-2.82, P = .47). CMR LVEF was similar between randomization groups at the end of the randomization phase (Group A: LVEF 58% [95% CI 54-60] vs Group B: LVEF 59% [95% CI 55-64], P = .236) and across study time points (mixed effects P = .37). Transthoracic echocardiography characteristics, N-terminal pro-B-type natriuretic peptide, functional status, quality of life and AF burden were similar on vs off HF therapy in the overall population.
Withdrawal of HF therapy following AF rhythm control for prior AFCM and recovered LVEF was not associated with a decline in LVEF for most patients in the following 6 months.
心房颤动介导的心肌病（AFCM）是左心室收缩功能障碍的一个重要可逆原因。目前的临床实践是，尽管左心室射血分数（LVEF）已恢复正常，但仍对心力衰竭（HF）进行不确定的药物治疗。然而，除了节律控制外，维持正常LVEF是否有必要尚不确定。
这项在2021年至2024年期间进行的多中心随机试验，研究了AFCM患者在房颤节律控制和LVEF恢复正常后分阶段停用HF治疗的影响。参与者被随机（1:1）分为早期停药组（A组）或继续治疗6个月后延迟停药组（B组），采用交叉设计。主要终点是在6个月时随机比较心脏磁共振成像（CMR）LVEF维持≥50%的情况，在此期间A组已停用治疗，B组仍在接受治疗。次要结局包括心脏重塑、功能状态、生物标志物、生活质量以及HF治疗期间和停药后心律失常的复发情况。总随访时间为12个月。
在2021年7月至2024年5月期间，共纳入60例患者（年龄60[55 - 65]岁，既往持续性房颤<1年，房颤节律控制后（97%为导管消融）维持窦性心律至少6个月）。所有参与者均完成了治疗停药和12个月的随访。在最初的随机比较中，6个月时，90%接受HF治疗停药的参与者（A组）LVEF维持≥50%，而继续药物治疗的参与者（B组）这一比例为100%（优势比[OR]1.18，95%置信区间[CI]0.27 - 2.82，P = 0.47）。随机分组阶段结束时，随机分组之间的CMR LVEF相似（A组：LVEF 58%[95%CI 54 - 60]，B组：LVEF 59%[95%CI 55 - 64]，P = 0.236），且在整个研究时间点上相似（混合效应P = 0.37）。在总体人群中，HF治疗期间和停药后经胸超声心动图特征、N末端B型利钠肽原、功能状态、生活质量和房颤负荷相似。
对于既往AFCM且LVEF已恢复正常的患者，房颤节律控制后停用HF治疗，在接下来的6个月中，大多数患者的LVEF并未下降。
