Prophylactic use of an implantable cardioverter-defibrillator after acute myocardial infarction
Prophylactic use of an implantable cardioverter-defibrillator after acute myocardial infarction
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DOI：
10.1056/nejmoa041489
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发表时间：
2004-12-09
影响因子：
158.5
通讯作者：
Connolly, SJ
中科院分区：
文献类型：
--
作者：
Hohnloser, SH;Kuck, KH;Connolly, SJ
背景：植入式心律转复除颤器(ICD)疗法已被证明可以提高各种心脏疾病患者的存活率，这些患者是室性心律失常的高危人群。心肌梗死后早期患者是否受益尚不清楚。方法：我们进行了急性心肌梗死除颤器试验，这是一项随机、开放的比较，在心肌梗死后6至40天，332名患者接受ICD治疗，342名患者不接受ICD治疗。我们纳入了左心功能降低(左心室射血分数，0.35或更低)和心脏自主神经功能受损(表现为心率变异性降低或动态心电图24小时平均心率升高)的患者。主要结果是各种原因造成的死亡率。结果：在平均(+/-SD)30+/-13个月的随访期内，两组患者的总死亡率没有差异：在120例死亡患者中，ICD组62例，对照组58例(ICD组死亡风险比1.08；95%可信区间0.76-1.55；P=0.66)。冠心病组因心律失常死亡12例，对照组29例(危险比0.42；95%可信区间0.22~0.83；P=0.009)。相比之下，ICD组有50人死于非心律失常原因，对照组有29人死亡(ICD组的风险比为1.75；95%可信区间为1.11至2.76；P=0.02)。结论：预防性ICD治疗不能降低最近发生心肌梗死的高危患者的总死亡率。虽然ICD治疗与心律失常死亡率的降低有关，但这被非心律失常原因死亡率的增加所抵消。
Background: Implantable cardioverter-defibrillator (ICD) therapy has been shown to improve survival in patients with various heart conditions who are at high risk for ventricular arrhythmias. Whether benefit occurs in patients early after myocardial infarction is unknown.Methods: We conducted the Defibrillator in Acute Myocardial Infarction Trial, a randomized, open-label comparison of ICD therapy (in 332 patients) and no ICD therapy (in 342 patients) 6 to 40 days after a myocardial infarction. We enrolled patients who had reduced left ventricular function (left ventricular ejection fraction, 0.35 or less) and impaired cardiac autonomic function (manifested as depressed heart-rate variability or an elevated average 24-hour heart rate on Holter monitoring). The primary outcome was mortality from any cause. Death from arrhythmia was a predefined secondary outcome.Results: During a mean (+/-SD) follow-up period of 30+/-13 months, there was no difference in overall mortality between the two treatment groups: of the 120 patients who died, 62 were in the ICD group and 58 in the control group (hazard ratio for death in the ICD group, 1.08; 95 percent confidence interval, 0.76 to 1.55; P=0.66). There were 12 deaths due to arrhythmia in the ICD group, as compared with 29 in the control group (hazard ratio in the ICD group, 0.42; 95 percent confidence interval, 0.22 to 0.83; P=0.009). In contrast, there were 50 deaths from nonarrhythmic causes in the ICD group and 29 in the control group (hazard ratio in the ICD group, 1.75; 95 percent confidence interval, 1.11 to 2.76; P=0.02).Conclusions: Prophylactic ICD therapy does not reduce overall mortality in high-risk patients who have recently had a myocardial infarction. Although ICD therapy was associated with a reduction in the rate of death due to arrhythmia, that was offset by an increase in the rate of death from nonarrhythmic causes.