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糖尿病、糖蛋白IIb/IIIa阻滞剂与肝素:一项多中心试验中复杂相互作用的证据。EPILOG研究组。

Diabetes mellitus, glycoprotein IIb/IIIa blockade, and heparin: evidence for a complex interaction in a multicenter trial. EPILOG Investigators.

作者信息

Kleiman N S, Lincoff A M, Kereiakes D J, Miller D P, Aguirre F V, Anderson K M, Weisman H F, Califf R M, Topol E J

机构信息

Baylor College of Medicine and the Methodist Hospital, Houston, Tex, USA.

出版信息

Circulation. 1998 May 19;97(19):1912-20. doi: 10.1161/01.cir.97.19.1912.

DOI:10.1161/01.cir.97.19.1912
PMID:9609084
Abstract

BACKGROUND

After angioplasty, major complications and ischemic events occur more frequently in diabetic than nondiabetic patients. To determine whether treatment with abciximab is effective in reducing these events in diabetics, we analyzed characteristics and outcomes of diabetic patients enrolled in a large multicenter study (EPILOG).

METHODS AND RESULTS

Of 2792 patients enrolled, 638 (23%) were diabetic. Diabetic patients were older, shorter, and heavier; more likely to be female and have three-vessel disease, prior coronary artery bypass graft surgery, a history of hypertension, or a recent myocardial infarction; and less likely to be current smokers than their nondiabetic counterparts. During hospitalization, death, myocardial infarction, or urgent revascularization occurred in 7.1% of diabetics and 7.5% of nondiabetics. By 6 months, the composite of death and myocardial infarction had occurred in 8.8% of diabetic patients and 7.4% of nondiabetics, whereas death, myocardial infarction, or revascularization had occurred in 27.2% and 22.6%, respectively. Abciximab treatment reduced death or myocardial infarction among diabetic and nondiabetic patients (hazard ratios, 0.28 [95% confidence interval (CI), 0.13 to 0.57] and 0.47 [95% CI, 0.33 to 0.70] at 30 days for diabetics and nondiabetics, respectively, and 0.36 [95% CI, 0.21 to 0.61] and 0.60 [95% CI, 0.44 to 0.82] at 6 months for diabetics and nondiabetics, respectively). Abciximab reduced target vessel revascularization among nondiabetic patients (hazard ratio, 0.78 [95% CI, 0.63 to 0.96]) but not among diabetics (hazard ratio, 1.4 [95% CI, 0.94 to 2.08]). When standard- and low-dose heparin adjuncts were compared, diabetics receiving abciximab with standard-dose heparin had marginally greater reductions in the composite of death and myocardial infarction and in target vessel revascularization than diabetics assigned to abciximab with low-dose heparin.

CONCLUSIONS

Abciximab treatment in diabetic patients led to a reduction in the composite of death and myocardial infarction, which was at least as great as that seen in nondiabetic patients. However, target vessel revascularization was reduced in nondiabetic but not diabetic patients. This effect may be associated in part with lower doses of heparin. These differences may be related to differences in the platelet and coagulation systems between diabetics and nondiabetics, the greater extent of coronary artery disease in diabetics, or patient selection and management factors.

摘要

背景

血管成形术后,糖尿病患者比非糖尿病患者更常发生严重并发症和缺血性事件。为了确定阿昔单抗治疗是否能有效减少糖尿病患者的这些事件,我们分析了一项大型多中心研究(EPILOG)中纳入的糖尿病患者的特征和结局。

方法与结果

在纳入的2792例患者中,638例(23%)为糖尿病患者。糖尿病患者年龄更大、身高更矮、体重更重;女性更多,更易患三支血管病变、曾接受冠状动脉搭桥手术、有高血压病史或近期心肌梗死;与非糖尿病患者相比,当前吸烟者较少。住院期间,7.1%的糖尿病患者和7.5%的非糖尿病患者发生死亡、心肌梗死或紧急血管重建。到6个月时,8.8%的糖尿病患者和7.4%的非糖尿病患者发生死亡和心肌梗死的复合事件,而死亡、心肌梗死或血管重建分别发生在27.2%和22.6%的患者中。阿昔单抗治疗降低了糖尿病和非糖尿病患者的死亡或心肌梗死发生率(糖尿病患者和非糖尿病患者在30天时的风险比分别为0.28[95%置信区间(CI),0.13至0.57]和0.47[95%CI,0.33至0.70],在6个月时分别为0.36[95%CI,0.21至0.61]和0.60[95%CI,0.44至0.82])。阿昔单抗降低了非糖尿病患者的靶血管重建率(风险比,0.78[95%CI,0.63至0.96]),但未降低糖尿病患者的靶血管重建率(风险比,1.4[95%CI,0.94至2.08])。当比较标准剂量和低剂量肝素辅助治疗时,接受阿昔单抗与标准剂量肝素治疗的糖尿病患者在死亡和心肌梗死复合事件以及靶血管重建方面的降低幅度略大于接受阿昔单抗与低剂量肝素治疗的糖尿病患者。

结论

糖尿病患者接受阿昔单抗治疗可降低死亡和心肌梗死的复合发生率,至少与非糖尿病患者相当。然而,靶血管重建在非糖尿病患者中降低,而在糖尿病患者中未降低。这种效应可能部分与较低剂量的肝素有关。这些差异可能与糖尿病患者和非糖尿病患者血小板和凝血系统的差异、糖尿病患者冠状动脉疾病程度更严重或患者选择及管理因素有关。

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