比伐卢定在当前临床实践中接受经皮冠状动脉介入治疗的糖尿病患者中的疗效和安全性。

Efficacy and safety of bivalirudin in patients with diabetes mellitus undergoing percutaneous coronary intervention in current clinical practice.

作者信息

Kim Luke K, Wong S Chiu, Minutello Robert M, Bergman Geoffrey, Feldman Dmitriy N

机构信息

New York Presbyterian Hospital, Weill Cornell Medical College, Greenberg Division of Cardiology, 520 East 70th Street, New York, NY 10021, USA.

出版信息

J Invasive Cardiol. 2010 Mar;22(3):94-100.

PMID:20197573

Abstract

OBJECTIVES

This study sought to evaluate the short- and long-term efficacy and safety of bivalirudin in diabetic patients undergoing percutaneous coronary intervention (PCI) in contemporary clinical practice.

BACKGROUND

Early trials of platelet glycoprotein (GP) IIb/IIIa inhibitors have suggested a survival benefit in diabetic patients undergoing PCI. More recently, randomized trials have demonstrated that diabetic patients have similar protection from acute ischemic events, while lowering the risk of bleeding complications, when treated with bivalirudin monotherapy versus heparin plus GP IIb/IIIa blockade. However, the impact of bivalirudin use on long-term outcomes in diabetic patients undergoing PCI remains unclear.

METHODS AND RESULTS

Using the Cornell Angioplasty Registry, we studied 786 consecutive diabetic patients undergoing urgent or elective PCI with a mean clinical follow up of 24.6 +/- 7.8 months. Of these, 428 patients (54.5%) received bivalirudin monotherapy and 358 patients (45.5%) received unfractionated heparin (UFH) plus GP IIb/IIIa inhibition. The incidence of in-hospital death (0% vs. 0.3%; p = 0.46), post-procedural myocardial infarction (MI) (4.7% vs. 7.0%; p = 0.169), and major adverse cardiovascular events (MACE) (death, MI, stroke or urgent revascularization) (4.9% vs. 7.3%; p = 0.176) was similar in the two groups, with less minor bleeding (9.6% vs. 14.5%; p = 0.035) in the bivalirudin vs. UFH plus GP IIb/IIIa inhibitor group, respectively. By the end of follow up, there were 38 (8.9%) deaths in the bivalirudin vs. 19 (5.3%) deaths in the GP IIb/IIIa inhibitor arm (hazard ratio [HR] 1.8, 95% confidence interval [CI] 1.0-3.1; p = 0.04). However, after a propensity score-adjusted multivariate Cox regression analysis, there was no longer a significant difference in long-term mortality between the two groups (HR 1.63; chi(2) = 2.61; 95% CI 0.90-2.94; p = 0.106).

CONCLUSIONS

These findings indicate that in diabetic patients, bivalirudin monotherapy results in similar protection from acute ischemic events and long-term mortality, while lowering the risk of minor bleeding in comparison to UFH plus GP IIb/IIIa inhibition.

摘要

目的

本研究旨在评估在当代临床实践中，比伐卢定用于接受经皮冠状动脉介入治疗（PCI）的糖尿病患者的短期和长期疗效及安全性。

背景

早期血小板糖蛋白（GP）IIb/IIIa抑制剂试验提示，接受PCI的糖尿病患者有生存获益。最近，随机试验表明，与肝素加GP IIb/IIIa阻滞剂相比，比伐卢定单药治疗时，糖尿病患者预防急性缺血事件的效果相似，同时出血并发症风险降低。然而，比伐卢定用于接受PCI的糖尿病患者的长期预后影响仍不明确。

方法与结果

利用康奈尔血管成形术登记处的数据，我们研究了786例连续接受紧急或择期PCI的糖尿病患者，平均临床随访24.6±7.8个月。其中，428例患者（54.5%）接受比伐卢定单药治疗，358例患者（45.5%）接受普通肝素（UFH）加GP IIb/IIIa抑制治疗。两组的院内死亡发生率（0%对0.3%；p = 0.46）、术后心肌梗死（MI）发生率（4.7%对7.0%；p = 0.169）和主要不良心血管事件（MACE，死亡、MI、卒中或紧急血运重建）发生率（4.9%对7.3%；p = 0.176）相似，比伐卢定组的轻微出血较少（9.6%对14.5%；p = 0.035），而UFH加GP IIb/IIIa抑制剂组较多。随访结束时，比伐卢定组有38例（8.9%）死亡，而GP IIb/IIIa抑制剂组有19例（5.3%）死亡（风险比[HR] 1.8，95%置信区间[CI] 1.0 - 3.1；p = 0.04）。然而，经过倾向评分调整的多因素Cox回归分析后，两组长期死亡率不再有显著差异（HR 1.63；χ(2) = 2.61；95% CI 0.90 - 2.94；p = 0.106）。