比伐芦定用于急性冠脉综合征患者。

Bivalirudin for patients with acute coronary syndromes.

作者信息

Stone Gregg W, McLaurin Brent T, Cox David A, Bertrand Michel E, Lincoff A Michael, Moses Jeffrey W, White Harvey D, Pocock Stuart J, Ware James H, Feit Frederick, Colombo Antonio, Aylward Philip E, Cequier Angel R, Darius Harald, Desmet Walter, Ebrahimi Ramin, Hamon Martial, Rasmussen Lars H, Rupprecht Hans-Jürgen, Hoekstra James, Mehran Roxana, Ohman E Magnus

机构信息

Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY 10022, USA.

出版信息

N Engl J Med. 2006 Nov 23;355(21):2203-16. doi: 10.1056/NEJMoa062437.

DOI:10.1056/NEJMoa062437

PMID:17124018

Abstract

BACKGROUND

Current guidelines for patients with moderate- or high-risk acute coronary syndromes recommend an early invasive approach with concomitant antithrombotic therapy, including aspirin, clopidogrel, unfractionated or low-molecular-weight heparin, and glycoprotein IIb/IIIa inhibitors. We evaluated the role of thrombin-specific anticoagulation with bivalirudin in such patients.

METHODS

We assigned 13,819 patients with acute coronary syndromes to one of three antithrombotic regimens: unfractionated heparin or enoxaparin plus a glycoprotein IIb/IIIa inhibitor, bivalirudin plus a glycoprotein IIb/IIIa inhibitor, or bivalirudin alone. The primary end points were a composite ischemia end point (death, myocardial infarction, or unplanned revascularization for ischemia), major bleeding, and the net clinical outcome, defined as the combination of composite ischemia or major bleeding.

RESULTS

Bivalirudin plus a glycoprotein IIb/IIIa inhibitor, as compared with heparin plus a glycoprotein IIb/IIIa inhibitor, was associated with noninferior 30-day rates of the composite ischemia end point (7.7% and 7.3%, respectively), major bleeding (5.3% and 5.7%), and the net clinical outcome end point (11.8% and 11.7%). Bivalirudin alone, as compared with heparin plus a glycoprotein IIb/IIIa inhibitor, was associated with a noninferior rate of the composite ischemia end point (7.8% and 7.3%, respectively; P=0.32; relative risk, 1.08; 95% confidence interval [CI], 0.93 to 1.24) and significantly reduced rates of major bleeding (3.0% vs. 5.7%; P<0.001; relative risk, 0.53; 95% CI, 0.43 to 0.65) and the net clinical outcome end point (10.1% vs. 11.7%; P=0.02; relative risk, 0.86; 95% CI, 0.77 to 0.97).

CONCLUSIONS

In patients with moderate- or high-risk acute coronary syndromes who were undergoing invasive treatment with glycoprotein IIb/IIIa inhibitors, bivalirudin was associated with rates of ischemia and bleeding that were similar to those with heparin. Bivalirudin alone was associated with similar rates of ischemia and significantly lower rates of bleeding. (ClinicalTrials.gov number, NCT00093158 [ClinicalTrials.gov].).

摘要

背景

当前针对中高危急性冠脉综合征患者的指南推荐采用早期侵入性治疗方法并同时进行抗栓治疗，包括阿司匹林、氯吡格雷、普通肝素或低分子肝素以及糖蛋白IIb/IIIa抑制剂。我们评估了比伐卢定进行凝血酶特异性抗凝在这类患者中的作用。

方法

我们将13819例急性冠脉综合征患者分配至三种抗栓治疗方案之一：普通肝素或依诺肝素加糖蛋白IIb/IIIa抑制剂、比伐卢定加糖蛋白IIb/IIIa抑制剂、或单用比伐卢定。主要终点为复合缺血终点（死亡、心肌梗死或因缺血进行的非计划血管重建）、大出血以及净临床结局，净临床结局定义为复合缺血或大出血的联合情况。

结果

与肝素加糖蛋白IIb/IIIa抑制剂相比，比伐卢定加糖蛋白IIb/IIIa抑制剂在30天复合缺血终点发生率（分别为7.7%和7.3%）、大出血发生率（分别为5.3%和5.7%）以及净临床结局终点发生率（分别为11.8%和11.7%）方面具有非劣效性。与肝素加糖蛋白IIb/IIIa抑制剂相比，单用比伐卢定在复合缺血终点发生率方面具有非劣效性（分别为7.8%和7.3%；P = 0.32；相对危险度，1.08；95%置信区间[CI]，0.93至1.24），且大出血发生率（3.0%对5.7%；P<0.001；相对危险度，0.53；95% CI，0.43至0.65）和净临床结局终点发生率（10.1%对11.7%；P = 0.02；相对危险度，0.86；95% CI，0.77至0.97）显著降低。