Mitra B, Phillips L, Cameron P A, Billah B, Reid C
Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
Anaesth Intensive Care. 2010 Jul;38(4):671-7. doi: 10.1177/0310057X1003800409.
We investigated whether there was an association between recombinant activated factor VII (rFVIIa) use in cardiac surgery and thromboembolic events by comparing cases in two medical registries. The incidence of thromboembolic events in patients undergoing cardiac surgery (except isolated coronary artery bypass grafts) who had received rFVIIa and were entered into the Australian and New Zealand Haemostasis Registry was compared with the background incidence in patients entered in the Australasian Society for Cardiac and Thoracic Surgeons database. Mortality, length of hospital stay and thromboembolic complications such as stroke, perioperative myocardial infarction and pulmonary embolism data were analysed. A total of 705 patients in the Registry were compared with 6554 patients in the Thoracic Surgeons database. The use of rFVIIa was independently associated with higher mortality (odds ratio 2.55, P < 0.001) and longer hospital stay (odds ratio 1.54, P = 0.020). However multiple regression analyses showed no independent association between rFVIIa and stroke (odds ratio 1.0, P = 0.994) or perioperative myocardial infarction (odds ratio 0.29, P = 0.053), while the use of rFVIIa was associated with fewer pulmonary emboli (odds ratio 0.02, P < 0.001). These findings indicate that patients who received rFVIIa had increased mortality and length of hospital stay, as expected, but that rFVIIa use was not associated with an increased incidence of stroke or perioperative myocardial infarction. In the absence of randomised controlled clinical trials, this analysis suggests that the off-label use of rFVIIa in cardiac surgery does not significantly increase thromboembolic events.
我们通过比较两个医学登记处的病例，研究了心脏手术中使用重组活化因子VII（rFVIIa）与血栓栓塞事件之间是否存在关联。将接受rFVIIa并纳入澳大利亚和新西兰止血登记处的心脏手术患者（孤立冠状动脉搭桥术除外）的血栓栓塞事件发生率，与纳入澳大利亚和新西兰心脏和胸外科医生协会数据库的患者的背景发生率进行比较。分析了死亡率、住院时间以及血栓栓塞并发症（如中风、围手术期心肌梗死和肺栓塞）的数据。登记处的705名患者与胸外科医生数据库中的6554名患者进行了比较。使用rFVIIa与较高的死亡率（比值比2.55，P<0.001）和较长的住院时间（比值比1.54，P = 0.020）独立相关。然而，多元回归分析显示rFVIIa与中风（比值比1.0，P = 0.994）或围手术期心肌梗死（比值比0.29，P = 0.053）之间无独立关联，而使用rFVIIa与较少的肺栓塞相关（比值比0.02，P<0.001）。这些发现表明，接受rFVIIa的患者死亡率和住院时间增加，正如预期的那样，但使用rFVIIa与中风或围手术期心肌梗死的发生率增加无关。在缺乏随机对照临床试验的情况下，该分析表明心脏手术中rFVIIa的标签外使用不会显著增加血栓栓塞事件。
