比伐卢定单药治疗糖尿病合并急性冠脉综合征患者的安全性和有效性：来自ACUITY（急性导管插入术和紧急干预分诊策略）试验的报告。

Safety and efficacy of bivalirudin monotherapy in patients with diabetes mellitus and acute coronary syndromes: a report from the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial.

作者信息

Feit Frederick, Manoukian Steven V, Ebrahimi Ramin, Pollack Charles V, Ohman E Magnus, Attubato Michael J, Mehran Roxana, Stone Gregg W

机构信息

Division of Cardiology, Department of Medicine, New York University School of Medicine, New York, New York, USA.

出版信息

J Am Coll Cardiol. 2008 Apr 29;51(17):1645-52. doi: 10.1016/j.jacc.2007.11.081.

DOI:10.1016/j.jacc.2007.11.081

PMID:18436116

Abstract

OBJECTIVES

We sought to evaluate clinical outcomes of patients with diabetes mellitus in the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial, overall and by treatment arm.

BACKGROUND

In the ACUITY trial, 13,819 patients with moderate- or high-risk acute coronary syndromes (ACS) were randomized to heparin (unfractionated or enoxaparin) plus glycoprotein IIb/IIIa inhibition (GPI), bivalirudin plus GPI, or bivalirudin monotherapy. Compared with heparin plus GPI, bivalirudin monotherapy resulted in similar protection from ischemic events with less major bleeding. Whether these results apply to patients with diabetes is unknown.

METHODS

We evaluated the impact of diabetes on 30-day net adverse clinical outcomes (composite ischemia [death, myocardial infarction, or unplanned ischemic revascularization] or major bleeding), overall and by antithrombotic strategy.

RESULTS

Diabetes was present in 3,852 randomized patients (27.9%). Compared with nondiabetic patients, diabetic patients had higher 30-day rates of net adverse clinical outcomes (12.9% vs. 10.6%; p < 0.001), composite ischemia (8.7% vs. 7.2%; p = 0.003), and major bleeding (5.7% vs. 4.2%; p < 0.001). Among diabetic patients, compared with heparin plus GPI, bivalirudin plus GPI resulted in similar rates of net adverse clinical outcomes (14.0% vs. 13.8%; p = 0.89), while bivalirudin monotherapy resulted in a similar rate of composite ischemia (7.9% vs. 8.9%; p = 0.39) and less major bleeding (3.7% vs. 7.1%; p < 0.001), yielding fewer net adverse clinical outcomes (10.9% vs. 13.8%; p = 0.02).

CONCLUSIONS

Diabetic patients with ACS managed invasively have higher rates of composite ischemia and major bleeding. Compared with treatment with heparin plus GPI, bivalirudin monotherapy provides similar protection from ischemic events with less major bleeding, resulting in a significant reduction in net adverse clinical outcomes.

摘要

目的

我们试图在急性导管插入术和紧急干预分诊策略（ACUITY）试验中评估糖尿病患者的临床结局，包括总体情况及按治疗组分析。

背景

在ACUITY试验中，13819例中高危急性冠脉综合征（ACS）患者被随机分为肝素（普通肝素或依诺肝素）加糖蛋白IIb/IIIa抑制剂（GPI）组、比伐卢定加GPI组或比伐卢定单药治疗组。与肝素加GPI相比，比伐卢定单药治疗在减少严重出血的情况下对缺血事件的保护作用相似。这些结果是否适用于糖尿病患者尚不清楚。

方法

我们评估了糖尿病对30天净不良临床结局（复合缺血[死亡、心肌梗死或计划外缺血性血运重建]或严重出血）的影响，包括总体情况及按抗栓策略分析。

结果

3852例随机分组患者（27.9%）患有糖尿病。与非糖尿病患者相比，糖尿病患者30天净不良临床结局发生率更高（12.9%对10.6%；p<0.001），复合缺血发生率更高（8.7%对7.2%；p=0.003），严重出血发生率更高（5.7%对4.2%；p<0.001）。在糖尿病患者中，与肝素加GPI相比，比伐卢定加GPI的净不良临床结局发生率相似（14.0%对13.8%；p=0.89），而比伐卢定单药治疗的复合缺血发生率相似（7.9%对8.9%；p=0.39），严重出血更少（3.7%对7.1%；p<0.001），净不良临床结局更少（10.9%对13.8%；p=0.02）。