White Harvey D, Gallo Richard, Cohen Marc, Steg Ph Gabriel, Aylward Philip E, Bode Christoph, Steinhubl Steve, Montalescot Gilles
Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand.
Am Heart J. 2009 Jan;157(1):125-31. doi: 10.1016/j.ahj.2008.08.019. Epub 2008 Nov 12.
The STEEPLE trial assessed outcomes of patients undergoing elective percutaneous coronary intervention randomized to receive a bolus of intravenous enoxaparin (0.5 or 0.75 mg/kg, n = 2,298) or activated clotting time-adjusted unfractionated heparin (UFH, n = 1,230), stratified according to planned glycoprotein IIb/IIIa inhibitor use.
In this subanalysis, we assessed outcomes in patients with renal impairment (creatinine clearance < or =60 mL/min, n = 659).
Major bleeding occurred more often in patients with renal impairment compared with those without (2.7% vs 1.5%, P = .04). Enoxaparin was associated with less major bleeding than UFH with normal renal function (0.9% for enoxaparin 0.5 mg/kg or 1.0% for enoxaparin 0.75 mg/kg vs 2.6%, respectively; both P = .01 vs UFH), with a trend toward less major bleeding with impaired renal function (2.6% or 1.8% vs 3.8%, P = .18 for enoxaparin 0.5 mg/kg and P = .47 for 0.75 mg/kg vs UFH). Minor bleeding rates were similar irrespective of renal function or anticoagulation regimen. The incidence of death, nonfatal myocardial infarction, or urgent target-vessel revascularization was similar between patients with and without renal impairment (5.7% vs 6.5%, P = .45). In patients with renal impairment, event rates were 6.2% or 5.3% with enoxaparin vs 5.6% with UFH (P = nonsignificant). Target anticoagulation levels were achieved 4 to 5 times more often with enoxaparin compared with UFH in patients with normal and impaired renal function (both P < .0001).
A single bolus of enoxaparin was associated with similar ischemic events and a trend for less major bleeding compared with UFH in patients with renal impairment undergoing percutaneous coronary intervention. Enoxaparin can be administered safely without dose adjustment in these patients.
STEEPLE试验评估了接受择期经皮冠状动脉介入治疗的患者的预后，这些患者被随机分配接受静脉注射依诺肝素推注（0.5或0.75mg/kg，n = 2298）或活化凝血时间调整的普通肝素（UFH，n = 1230），并根据计划使用糖蛋白IIb/IIIa抑制剂进行分层。
在这项亚分析中，我们评估了肾功能损害患者（肌酐清除率≤60mL/分钟，n = 659）的预后。
与无肾功能损害的患者相比，肾功能损害患者发生大出血的情况更常见（2.7%对1.5%，P = 0.04）。在肾功能正常的情况下，依诺肝素比普通肝素导致的大出血更少（依诺肝素0.5mg/kg为0.9%或依诺肝素0.75mg/kg为1.0%，分别对比普通肝素的2.6%；与普通肝素相比，P均= 0.01），在肾功能受损时也有大出血更少的趋势（依诺肝素0.5mg/kg为2.6%或1.8%，依诺肝素0.75mg/kg为1.8%对比普通肝素的3.8%，依诺肝素0.5mg/kg时P = 0.18，依诺肝素0.75mg/kg时P = 0.47对比普通肝素）。无论肾功能或抗凝方案如何，小出血率相似。有和无肾功能损害的患者之间死亡、非致命性心肌梗死或紧急靶血管血运重建的发生率相似（5.7%对6.5%，P = 0.45）。在肾功能损害患者中，依诺肝素的事件发生率为6.2%或5.3%，普通肝素为（5.6%，P = 无显著性差异）。在肾功能正常和受损的患者中，与普通肝素相比，依诺肝素达到目标抗凝水平的频率高4至5倍（P均<0.0001）。
对于接受经皮冠状动脉介入治疗的肾功能损害患者，单次推注依诺肝素与普通肝素相比，缺血事件相似，大出血有减少趋势。在这些患者中，依诺肝素无需调整剂量即可安全给药。
