纽约心脏协会功能分级与植入式心脏复律除颤器在射血分数降低的非缺血性心力衰竭中的应用：丹麦试验的扩展随访。
New York Heart Association functional class and implantable cardioverter-defibrillator in non-ischaemic heart failure with reduced ejection fraction: Extended follow-up of the DANISH trial.
机构信息
Department of Cardiology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Department of Cardiology, Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Denmark.
出版信息
Eur J Heart Fail. 2024 Jun;26(6):1423-1431. doi: 10.1002/ejhf.3239. Epub 2024 May 11.
AIMS
Current guidelines recommend implantable cardioverter-defibrillator (ICD) therapy in patients with heart failure, a left ventricular ejection fraction of ≤35%, and New York Heart Association (NYHA) class II-III. However, the evidence regarding the benefit of primary prevention ICD is less consistent in patients with NYHA class III. We investigated the long-term effects of primary prevention ICD implantation according to NYHA class in an extended follow-up study of the DANISH trial.
METHODS AND RESULTS
The DANISH trial randomized 1116 patients with non-ischaemic heart failure with reduced ejection fraction (HFrEF) to ICD implantation or usual care. Outcomes were analysed according to NYHA class at baseline (NYHA class II and III/IV). The primary outcome was all-cause mortality. Of the 1116 patients randomized in the DANISH trial, 597 (53.5%) were in NYHA class II at baseline, 505 (45.3%) in NYHA class III, and 14 (1.3%) in NYHA class IV. During a median follow-up of 9.5 years, NYHA class III/IV, compared with NYHA class II, were associated with a greater long-term rate of all-cause mortality (hazard ratio [HR] 1.52, 95% confidence interval [CI] 1.20-1.93) and cardiovascular death (HR 1.95 [1.47-2.60]). ICD implantation, compared with usual care, did not reduce the long-term rate of all-cause mortality (all participants: HR 0.89 [95% CI 0.74-1.08]; NYHA class II: HR 0.85 [0.64-1.13]; NYHA class III/IV: HR 0.89 [0.69-1.14]; p = 0.78) or cardiovascular death (all participants: HR 0.87 [95% CI 0.70-1.09]; NYHA class II: HR 0.78 [0.54-1.12]; NYHA class III/IV: HR 0.89 [0.67-1.19]; p = 0.58), irrespective of NYHA class. Similarly, NYHA class did not modify the beneficial effects of ICD implantation on sudden cardiovascular death (all participants: HR 0.60 [95% CI 0.40-0.92]; NYHA class II: HR 0.73 [0.40-1.36]; NYHA class III/IV: HR 0.52 [0.29-0.94]; p = 0.39).
CONCLUSIONS
In patients with non-ischaemic HFrEF, ICD implantation, compared with usual care, did not reduce the overall mortality rate, but it did reduce sudden cardiovascular death, regardless of baseline NYHA class.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov NCT00542945.
目的
目前的指南建议在心力衰竭、左心室射血分数≤35%和纽约心脏协会（NYHA）心功能 II-III 级的患者中植入心脏再同步治疗除颤器（ICD）。然而，NYHA 心功能 III 级患者中初级预防 ICD 的益处证据不太一致。我们在 DANISH 试验的扩展随访研究中，根据 NYHA 心功能分级，研究了初级预防 ICD 植入的长期效果。
方法和结果
DANISH 试验将 1116 名非缺血性射血分数降低性心力衰竭（HFrEF）患者随机分为 ICD 植入组或常规治疗组。根据基线 NYHA 心功能分级（NYHA 心功能 II 级和 III/IV 级）分析结局。主要结局为全因死亡率。在 DANISH 试验中，1116 名随机患者中，597 名（53.5%）基线 NYHA 心功能 II 级，505 名（45.3%）NYHA 心功能 III 级，14 名（1.3%）NYHA 心功能 IV 级。中位随访 9.5 年后，与 NYHA 心功能 II 级相比，NYHA 心功能 III/IV 级与长期全因死亡率（风险比 [HR] 1.52，95%置信区间 [CI] 1.20-1.93）和心血管死亡（HR 1.95 [1.47-2.60]）增加相关。与常规治疗相比，ICD 植入并未降低全因死亡率（所有参与者：HR 0.89 [95%CI 0.74-1.08]；NYHA 心功能 II 级：HR 0.85 [0.64-1.13]；NYHA 心功能 III/IV 级：HR 0.89 [0.69-1.14]；p=0.78）或心血管死亡（所有参与者：HR 0.87 [95%CI 0.70-1.09]；NYHA 心功能 II 级：HR 0.78 [0.54-1.12]；NYHA 心功能 III/IV 级：HR 0.89 [0.67-1.19]；p=0.58），无论 NYHA 心功能分级如何。同样，NYHA 心功能分级也不能改变 ICD 植入对心脏性猝死的有益影响（所有参与者：HR 0.60 [95%CI 0.40-0.92]；NYHA 心功能 II 级：HR 0.73 [0.40-1.36]；NYHA 心功能 III/IV 级：HR 0.52 [0.29-0.94]；p=0.39）。
结论
在非缺血性 HFrEF 患者中，与常规治疗相比，ICD 植入并未降低总体死亡率，但确实降低了心脏性猝死的风险，无论基线 NYHA 心功能分级如何。
临床试验注册
ClinicalTrials.gov NCT00542945。
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