Withdrawal of heart failure therapy after atrial fibrillation rhythm control with ejection fraction normalization: the WITHDRAW-AF trial.

Current clinical practice is indefinite heart failure (HF) pharmacotherapy despite left ventricular ejection fraction (LVEF) normalization.

尽管左心室射血分数（LVEF）恢复正常，当前的临床实践仍不确定心力衰竭（HF）的药物治疗。

However, whether this is necessary to maintain normal LVEF, in addition to rhythm control, is uncertain.

然而，除了节律控制外，是否需要维持正常左心室射血分数（LVEF）尚不确定。

Methods

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.

这项多中心、随机试验在2021年至2024年期间进行，研究了在房颤节律控制和左心室射血分数（LVEF）正常化后，分阶段撤除心力衰竭（HF）治疗的影响。

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.

参与者被随机分配（1:1）到早期停药组（A组）或继续治疗6个月后延迟停药组（B组），采用交叉设计。

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comparison of cardiac magnetic resonance (CMR) LVEF maintenance ≥50% at 6 months, during which time Group A had withdrawn therapy and Group B remained on treatment.

主要终点是随机比较6个月内心脏磁共振（CMR）左心室射血分数（LVEF）维持≥50%，在此期间A组已停药而B组仍在治疗。

Secondary outcomes included cardiac remodelling, functional status, biomarkers, quality of life, and arrhythmia recurrence on vs off HF therapy.

次要结果包括心脏重塑、功能状态、生物标志物、生活质量以及心力衰竭治疗期间与治疗后心律失常的复发情况。

The total follow-up duration was 12 months.

总随访时间为12个月。

Results

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%]).

在2021年7月至2024年5月期间，共有60名患者参与研究（年龄60[55-65]岁，既往持续性房颤<1年，并在房颤节律控制后至少维持窦性心律6个月[97%通过导管消融]）。

All participants completed treatment withdrawal and 12-month follow-up.

所有参与者均完成了治疗撤除和12个月的随访。

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).

在最初的随机比较中，90%接受心力衰竭治疗撤除的参与者（A组）在6个月时保持左心室射血分数（LVEF）≥50%，而继续接受药物治疗的100%参与者（B组）也是如此（比值比[OR] 1.18，95%置信区间[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).

在随机化阶段结束时，随机化组之间的CMR LVEF相似（A组：LVEF 58% [95% CI 54-60] 对比 B组：LVEF 59% [95% CI 55-64]，P = .236），并且在整个研究时间点上也是如此（混合效应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.

在整体人群中，与心力衰竭治疗期间相比，心力衰竭治疗停用后，经胸超声心动图特征、N末端B型利钠肽前体、功能状态、生活质量以及房颤负荷相似。

Conclusions

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.

在先前因房颤相关心肌病（AFCM）并恢复左心室射血分数（LVEF）的患者中，停用心力衰竭治疗后，在随后的6个月内，大多数患者的LVEF并未出现下降。