Department of Pharmacy Practice and Pharmacy Administration, Philadelphia College of Pharmacy, University of the Sciences in Philadelphia, Philadelphia, PA, USA.
Int J Cardiol. 2010 Sep 24;144(1):36-41. doi: 10.1016/j.ijcard.2009.03.119. Epub 2009 May 5.
Chronic kidney disease (CKD) is a risk factor for coronary heart disease and bleeding with antithrombotic therapy in patients with acute coronary syndromes (ACS). We evaluated the effect of renal function on efficacy and outcomes in high-risk patients with NSTE ACS in the SYNERGY trial.
Creatinine clearance (CrCl) at the time of randomization was analyzed as a continuous variable added to multivariable logistic regression models for 30-day death or MI, non-CABG-associated TIMI major bleeding, GUSTO severe bleeding, and transfusion in the overall study population, patients undergoing coronary angiography, and patients undergoing PCI.
Of 9838 patients with a CrCl value, 70.6% (N=6950) had CrCl≥60 mL/min, 27.8% (N=2732) had CrCl 30-59 mL/min, and 1.6% (N=156) had CrCl<30 mL/min. No randomized treatment by CrCl interaction test was found to be statistically significant, suggesting renal insufficiency affected enoxaparin and unfractionated heparin outcomes similarly. After adjustment, CrCl was an independent predictor of 30-day death or MI (OR 1.06, 95% CI 1.03-1.09), TIMI major bleeding (OR 1.06, 95% CI 1.02-1.10), GUSTO severe bleeding (OR 1.10, 95% CI 1.03-1.17), and transfusion (OR 1.07, 95% CI 1.04-1.11).
Patients with CKD had higher rates of 30-day death or MI and bleeding than those without CKD, regardless of randomized antithrombin therapy. While this analysis suggests that there is a rise in bleeding events as CrCl falls for patients in either treatment group, it is unknown whether a reduction in dose would decrease bleeding risk.
慢性肾脏病（CKD）是急性冠状动脉综合征（ACS）患者抗血栓治疗时发生冠心病和出血的危险因素。我们评估了肾功能对 SYNERGY 试验中高危非 ST 段抬高型急性冠脉综合征（NSTE ACS）患者疗效和结局的影响。
在随机分组时，肌酐清除率（CrCl）被分析为一个连续变量，加入到全人群、行冠状动脉造影患者和行 PCI 患者的 30 天死亡或心梗、非 CABG 相关 TIMI 大出血、GUSTO 严重出血和输血的多变量逻辑回归模型中。
在 9838 例有 CrCl 值的患者中，70.6%（N=6950）CrCl≥60ml/min，27.8%（N=2732）CrCl 30-59ml/min，1.6%（N=156）CrCl＜30ml/min。CrCl 与随机治疗的交互检验未发现有统计学意义，提示肾功能不全对依诺肝素和未分级肝素的结局影响相似。校正后，CrCl 是 30 天死亡或心梗（OR 1.06，95%CI 1.03-1.09）、TIMI 大出血（OR 1.06，95%CI 1.02-1.10）、GUSTO 严重出血（OR 1.10，95%CI 1.03-1.17）和输血（OR 1.07，95%CI 1.04-1.11）的独立预测因素。
无论随机接受何种抗栓治疗，合并 CKD 的患者 30 天死亡或心梗和出血的发生率均高于不合并 CKD 的患者。尽管该分析提示，对于任一治疗组的患者，随着 CrCl 下降出血事件的发生率升高，但尚不清楚减少剂量是否会降低出血风险。
