AimsCurrent 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 resultsThe 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]; pinteraction = 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]; pinteraction = 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]; pinteraction = 0.39).ConclusionsIn 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 RegistrationClinicalTrials.gov NCT00542945.

中文翻译：

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纽约心脏协会功能分级和植入式心脏复律除颤器治疗射血分数降低的非缺血性心力衰竭：DANISH 试验的延长随访

目标当前指南建议对左心室射血分数≤35%、纽约心脏协会 (NYHA) II-III 级心力衰竭患者进行植入式心律转复除颤器 (ICD) 治疗。然而，关于一级预防 ICD 对 NYHA III 级患者的益处的证据不太一致。我们在 DANISH 试验的一项长期随访研究中，根据 NYHA 分级研究了一级预防 ICD 植入的长期效果。方法和结果 DANISH 试验将 1116 名射血分数降低 (HFrEF) 的非缺血性心力衰竭患者随机分为两组ICD 植入或常规护理。根据基线时的 NYHA 分级（NYHA II 级和 III/IV 级）对结果进行分析。主要结局是全因死亡率。在 DANISH 试验中随机分配的 1116 名患者中，基线时 597 名 (53.5%) 为 NYHA II 级，505 名 (45.3%) 为 NYHA III 级，14 名 (1.3%) 为 NYHA IV 级。在中位随访 9.5 年期间，与 NYHA II 级相比，NYHA III/IV 级与更高的长期全因死亡率相关（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]）。与常规护理相比，ICD 植入并未降低长期全因死亡率（所有参与者：HR 0.89 [95% CI 0.74–1.08]；NYHA II 级：HR 0.85 [0.64–1.13]；NYHA 级III/IV：HR 0.89 [0.69–1.14]；p相互作用= 0.78）或心血管死亡（所有参与者：HR 0.87 [95% CI 0.70–1.09]；NYHA II 级：HR 0.78 [0.54–1.12]；NYHA III/IV 级：HR 0.89 [0.67–1.19]；p相互作用= 0.58)，无论 NYHA 等级如何。同样，NYHA 分级并没有改变 ICD 植入对心血管性猝死的有益影响（所有参与者：HR 0.60 [95% CI 0.40–0.92]；NYHA II 级：HR 0.73 [0.40–1.36]；NYHA III/IV 级： HR 0.52 [0.29–0.94]；p相互作用= 0.39）。结论在非缺血性 HFrEF 患者中，与常规护理相比，ICD 植入并没有降低总体死亡率，但确实减少了心血管猝死，无论基线 NYHA 分级如何。临床试验注册ClinicalTrials.gov NCT00542945。