Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both
Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both
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DOI：
10.1056/nejmoa032292
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发表时间：
2003-11-13
影响因子：
158.5
通讯作者：
Trapani, A
中科院分区：
文献类型：
--
作者：
Pfeffer, MA;McMurray, JJV;Trapani, A
背景：血管紧张素转换酶（ACE）抑制剂如卡托普利可降低心肌梗死合并左心室收缩功能不全、心力衰竭或两者兼有的患者的死亡率和心血管发病率。在一项双盲试验中，我们比较了血管紧张素受体阻滞剂缬沙坦、ACE抑制剂卡托普利以及这两种药物联合使用对该患者死亡率的影响。方法：接受常规治疗的患者在急性心肌梗死后0.5 ~ 10天被随机分配到缬沙坦（4909例）、缬沙坦联合卡托普利（4885例）或卡托普利（4909例）的附加治疗组。主要终点是任何原因导致的死亡。结果：在24.7个月的中位随访期间，缬沙坦组979例患者死亡，缬沙坦联合卡托普利组941例患者死亡，卡托普利组958例患者死亡（缬沙坦联合卡托普利组与卡托普利组的风险比为1.00；97.5%可信区间为0.90 ~ 1.11；P=0.98；缬沙坦联合卡托普利组与卡托普利组的风险比为0.98；97.5%可信区间为0.89 ~ 1.09；P=0.73）。缬沙坦组与卡托普利组比较的单侧97.5%置信区间的上限在死亡率（P=0.004）和致命和非致命心血管事件的复合终点（P=0.004）的预先设定的非劣效性范围内
Background: Angiotensin-converting-enzyme (ACE) inhibitors such as captopril reduce mortality and cardiovascular morbidity among patients with myocardial infarction complicated by left ventricular systolic dysfunction, heart failure, or both. In a double-blind trial, we compared the effect of the angiotensin-receptor blocker valsartan, the ACE inhibitor captopril, and the combination of the two on mortality in this population of patients.Methods: Patients receiving conventional therapy were randomly assigned, 0.5 to 10 days after acute myocardial infarction, to additional therapy with valsartan (4909 patients), valsartan plus captopril (4885 patients), or captopril (4909 patients). The primary end point was death from any cause.Results: During a median follow-up of 24.7 months, 979 patients in the valsartan group died, as did 941 patients in the valsartan-and-captopril group and 958 patients in the captopril group (hazard ratio in the valsartan group as compared with the captopril group, 1.00; 97.5 percent confidence interval, 0.90 to 1.11; P=0.98; hazard ratio in the valsartan-and-captopril group as compared with the captopril group, 0.98; 97.5 percent confidence interval, 0.89 to 1.09; P=0.73). The upper limit of the one-sided 97.5 percent confidence interval for the comparison of the valsartan group with the captopril group was within the prespecified margin for noninferiority with regard to mortality (P=0.004) and with regard to the composite end point of fatal and nonfatal cardiovascular events (P