A comparison of aprotinin and lysine analogues in high-risk cardiac surgery
A comparison of aprotinin and lysine analogues in high-risk cardiac surgery
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DOI：
10.1056/nejmoa0802395
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发表时间：
2008-05-29
影响因子：
158.5
通讯作者：
Pretorius, Roanda
中科院分区：
文献类型：
--
作者：
Fergusson, Dean A.;Hebert, Paul C.;Pretorius, Roanda
背景：心脏手术中常使用抗纤溶药物，以减少出血和减少血液制品的暴露。我们试图确定抑肽酶在减少术后大出血和其他临床重要后果方面是否优于氨甲环酸或氨基己酸。方法：在这项多中心、双盲试验中，我们将2331名高危心脏手术患者随机分为三组：781例接受抑肽酶，770例接受氨甲环酸，780例接受氨基己酸。主要结果是术后大出血。次要结果包括30天内因任何原因死亡。结果：试验提前终止，因为接受抑肽酶治疗的患者死亡率较高。抑肽酶组共有74名患者(9.5%)出现大出血，而氨甲环酸组和氨基己酸组分别为93名(12.1%)和94名(12.1%)(抑肽酶组和氨基己酸组的相对危险度均为0.79；95%可信区间[CI]为0.59至1.05)。在30天时，抑肽酶组任何原因的死亡率为6.0%，而氨甲环酸组的死亡率为3.9%(相对风险为1.55；95%可信区间为0.99-2.42)，氨基己酸组的死亡率为4.0%(相对风险为1.52；95%可信区间为0.98-2.36)。与接受赖氨酸类似物的两组相比，抑肽酶组死亡的相对风险为1.53(95%CI，1.06~2.22)。结论：尽管大出血的风险可能略有降低，但与赖氨酸类似物相比，抑肽酶相关的强烈而持续的死亡趋势排除了它在高危心脏手术中的使用。(当前对照试验编号，ISRCTN15166455。)
Background: Antifibrinolytic agents are commonly used during cardiac surgery to minimize bleeding and to reduce exposure to blood products. We sought to determine whether aprotinin was superior to either tranexamic acid or aminocaproic acid in decreasing massive postoperative bleeding and other clinically important consequences.Methods: In this multicenter, blinded trial, we randomly assigned 2331 high-risk cardiac surgical patients to one of three groups: 781 received aprotinin, 770 received tranexamic acid, and 780 received aminocaproic acid. The primary outcome was massive postoperative bleeding. Secondary outcomes included death from any cause at 30 days.Results: The trial was terminated early because of a higher rate of death in patients receiving aprotinin. A total of 74 patients (9.5%) in the aprotinin group had massive bleeding, as compared with 93 (12.1%) in the tranexamic acid group and 94 (12.1%) in the aminocaproic acid group (relative risk in the aprotinin group for both comparisons, 0.79; 95% confidence interval [CI], 0.59 to 1.05). At 30 days, the rate of death from any cause was 6.0% in the aprotinin group, as compared with 3.9% in the tranexamic acid group (relative risk, 1.55; 95% CI, 0.99 to 2.42) and 4.0% in the aminocaproic acid group (relative risk, 1.52; 95% CI, 0.98 to 2.36). The relative risk of death in the aprotinin group, as compared with that in both groups receiving lysine analogues, was 1.53 (95% CI, 1.06 to 2.22).Conclusions: Despite the possibility of a modest reduction in the risk of massive bleeding, the strong and consistent negative mortality trend associated with aprotinin, as compared with the lysine analogues, precludes its use in high-risk cardiac surgery. (Current Controlled Trials number, ISRCTN15166455.).