比伐卢定与肝素用于不稳定型或心肌梗死后心绞痛冠状动脉血管成形术的比较：比伐卢定血管成形术研究的最终报告再分析

Bivalirudin versus heparin during coronary angioplasty for unstable or postinfarction angina: Final report reanalysis of the Bivalirudin Angioplasty Study.

作者信息

Bittl J A, Chaitman B R, Feit F, Kimball W, Topol E J

机构信息

Ocala Heart Institute, Munroe Regional Medical Center, Ocala, FL 34474, USA.

出版信息

Am Heart J. 2001 Dec;142(6):952-9. doi: 10.1067/mhj.2001.119374.

DOI:10.1067/mhj.2001.119374

PMID:11717596

Abstract

BACKGROUND

This study was a reanalysis of the Bivalirudin Angioplasty Study, which compared bivalirudin with high-dose heparin during coronary angioplasty for unstable angina.

METHODS

Differences in rates of death, myocardial infarction, or repeat revascularization were compared at 7, 90, and 180 days after angioplasty with intention-to-treat analysis.

RESULTS

The combined end point occurred in 135 of 2161 patients (6.2%) in the bivalirudin group and in 169 of 2151 patients (7.9%) in the heparin group at 7 days (P =.039). Differences persisted between the groups at 90 days (P =.012) and 180 days (P =.153). Bleeding occurred in 76 patients (3.5%) in the bivalirudin group versus 199 (9.3%) in the heparin group (P <.001).

CONCLUSIONS

This analysis supports the hypothesis that bivalirudin reduces ischemic complications and bleeding after angioplasty. Further trials are needed to evaluate bivalirudin versus heparin in conjunction with platelet-glycoprotein IIb/IIIa inhibitors and for coronary stenting.

摘要

背景

本研究是对比伐卢定血管成形术研究的重新分析，该研究比较了在不稳定型心绞痛的冠状动脉血管成形术中比伐卢定与大剂量肝素的疗效。

方法

采用意向性分析，比较血管成形术后7天、90天和180天死亡、心肌梗死或再次血管重建发生率的差异。

结果

7天时，比伐卢定组2161例患者中有135例（6.2%）出现联合终点事件，肝素组2151例患者中有169例（7.9%）出现联合终点事件（P = 0.039）。90天（P = 0.012）和180天（P = 0.153）时，两组间差异仍然存在。比伐卢定组76例患者（3.5%）发生出血，肝素组199例患者（9.3%）发生出血（P < 0.001）。