Hohnloser Stefan H, Kuck Karl Heinz, Dorian Paul, Roberts Robin S, Hampton John R, Hatala Robert, Fain Eric, Gent Michael, Connolly Stuart J
Department of Medicine, Division of Cardiology, J.W. Goethe University, Frankfurt, Germany.
N Engl J Med. 2004 Dec 9;351(24):2481-8. doi: 10.1056/NEJMoa041489.
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.
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.
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).
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.
植入式心脏复律除颤器(ICD)治疗已被证明可提高各种心脏病患者的生存率,这些患者发生室性心律失常的风险较高。心肌梗死后早期患者是否能从中获益尚不清楚。
我们开展了急性心肌梗死除颤器试验,这是一项随机、开放标签的试验,比较心肌梗死后6至40天接受ICD治疗的患者(332例)和未接受ICD治疗的患者(342例)。我们纳入了左心室功能降低(左心室射血分数为0.35或更低)且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监测显示24小时平均心率升高)的患者。主要结局是任何原因导致的死亡。心律失常导致的死亡是一个预先设定的次要结局。
在平均(±标准差)30±13个月的随访期内,两个治疗组的总死亡率没有差异:在120例死亡患者中,ICD组有62例,对照组有58例(ICD组的死亡风险比为1.08;95%置信区间为0.76至1.55;P = 0.66)。ICD组有12例死于心律失常,而对照组有29例(ICD组的风险比为0.42;95%置信区间为0.22至0.83;P = 0.009)。相比之下,ICD组有50例死于非心律失常原因,对照组有29例(ICD组的风险比为1.75;95%置信区间为1.11至2.76;P = 0.02)。
预防性ICD治疗不能降低近期发生心肌梗死的高危患者的总死亡率。虽然ICD治疗与心律失常导致的死亡率降低有关,但这被非心律失常原因导致的死亡率增加所抵消。