目的:目前的指南推荐对心力衰竭患者进行植入式心律转复除颤器(ICD)治疗,左心室射血分数≤35%,纽约心脏协会(NYHA)II-III级。然而,在NYHAⅢ级患者中,一级预防ICD获益的证据不太一致.我们在DANISH试验的长期随访研究中,根据NYHA分级调查了一级预防ICD植入的长期效果。
结果:DANISH试验将1116例射血分数降低(HFrEF)的非缺血性心力衰竭患者随机分配至ICD植入或常规治疗。根据基线时的NYHA等级(NYHA等级II和III/IV)分析结果。主要结果是全因死亡率。在DANISH试验中随机分配的1116名患者中,597(53.5%)在基线时属于NYHAII级,505(45.3%)为NYHA三级,在NYHA四级中,有14人(1.3%)。在9.5年的中位随访期间,NYHAIII/IV级,与NYHA二级相比,与全因死亡率(风险比[HR]1.52,95%置信区间[CI]1.20-1.93)和心血管死亡(HR1.95[1.47-2.60])的长期比率更高相关.ICD植入,与常规护理相比,没有降低全因死亡率的长期比率(所有参与者:HR0.89[95%CI0.74-1.08];NYHAII级:HR0.85[0.64-1.13];NYHAIII/IV级:HR0.89[0.69-1.14];pinteraction=0.78)或心血管死亡(所有参与者:HR0.87[95%CI0.70-1.09];NYHAII级:0.58-0.78[p不管NYHA等级。同样,NYHA分级未改变ICD植入对心血管猝死的有益影响(所有参与者:HR0.60[95%CI0.40-0.92];NYHAII级:HR0.73[0.40-1.36];NYHAIII/IV级:HR0.52[0.29-0.94];pinteraction=0.39)。
结论:在非缺血性HFrEF患者中,ICD植入,与常规护理相比,并没有降低总死亡率,但它确实减少了心血管猝死,无论基准NYHA等级如何。
背景:ClinicalTrials.govNCT00542945。
OBJECTIVE: 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.
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]; 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).
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.
BACKGROUND: ClinicalTrials.gov NCT00542945.