Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure
Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure
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DOI：
10.1056/nejmoa043399
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发表时间：
2005-01-20
影响因子：
158.5
通讯作者：
Ip, JH
中科院分区：
文献类型：
--
作者：
Bardy, GH;Lee, KL;Ip, JH
背景：心脏原因导致的猝死仍然是充血性心力衰竭（CHF）患者的主要死亡原因。胺碘酮或植入式心律转复除颤器（ICD）的治疗已被提出，以改善预后，在这样的patients.METHODS：我们随机分配2521例患者与纽约心脏协会（NYHA）II级或III级CHF和左心室射血分数（LVEF）为35%或更低的常规治疗CHF加安慰剂（847例），常规治疗加胺碘酮（845例），或常规治疗加保守编程，休克，单导联ICD（829例）。安慰剂和胺碘酮以双盲方式给药。主要终点是任何原因导致的死亡。结果：患者中位LVEF为25%; 70%为NYHA II级，30%为III级CHF。充血性心力衰竭的原因是缺血性的占52%，非缺血性的占48%。中位随访时间为45.5个月。安慰剂组有244例（29%）死亡，胺碘酮组有240例（28%），ICD组有182例（22%）。与安慰剂相比，胺碘酮与相似的死亡风险相关（风险比，1.06; 97.5%置信区间，0.86至1.30; P=0.53），ICD治疗与死亡风险降低23%相关。（0.77; 97.5%置信区间，0.62至0.96; P=0.007），五年后总人口死亡率绝对下降7.2个百分点。结果并没有根据任何缺血性或非缺血性原因的CHF，但他们根据不同的NYHA class.CONCLUSIONS：在NYHA II级或III级CHF和LVEF的35%或更低的患者，胺碘酮没有有利的影响生存，而单导线，休克只有ICD治疗降低总死亡率的23%。
BACKGROUND:Sudden death from cardiac causes remains a leading cause of death among patients with congestive heart failure (CHF). Treatment with amiodarone or an implantable cardioverter-defibrillator (ICD) has been proposed to improve the prognosis in such patients.METHODS:We randomly assigned 2521 patients with New York Heart Association (NYHA) class II or III CHF and a left ventricular ejection fraction (LVEF) of 35 percent or less to conventional therapy for CHF plus placebo (847 patients), conventional therapy plus amiodarone (845 patients), or conventional therapy plus a conservatively programmed, shock-only, single-lead ICD (829 patients). Placebo and amiodarone were administered in a double-blind fashion. The primary end point was death from any cause.RESULTS:The median LVEF in patients was 25 percent; 70 percent were in NYHA class II, and 30 percent were in class III CHF. The cause of CHF was ischemic in 52 percent and nonischemic in 48 percent. The median follow-up was 45.5 months. There were 244 deaths (29 percent) in the placebo group, 240 (28 percent) in the amiodarone group, and 182 (22 percent) in the ICD group. As compared with placebo, amiodarone was associated with a similar risk of death (hazard ratio, 1.06; 97.5 percent confidence interval, 0.86 to 1.30; P=0.53) and ICD therapy was associated with a decreased risk of death of 23 percent (0.77; 97.5 percent confidence interval, 0.62 to 0.96; P=0.007) and an absolute decrease in mortality of 7.2 percentage points after five years in the overall population. Results did not vary according to either ischemic or nonischemic causes of CHF, but they did vary according to the NYHA class.CONCLUSIONS:In patients with NYHA class II or III CHF and LVEF of 35 percent or less, amiodarone has no favorable effect on survival, whereas single-lead, shock-only ICD therapy reduces overall mortality by 23 percent.