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急性冠状动脉综合征中直接Xa因子抑制剂联合抗血小板治疗:随机试验的荟萃分析

Direct Xa inhibitors in addition to antiplatelet therapy in acute coronary syndrome: meta-analysis of randomized trials.

作者信息

Villablanca Pedro A, Holmes David, Mohananey Divyanshu, Briceno David F, Núñez Gil Ivan J, Kargoli Faraj, Gupta Tanush, Kizer Jorge R, Bortnick Anna E, Wiley Jose, Menegus Mark A, Pyo Robert, García Mario, Ramakrishna Harish, Mookadam Farouk

机构信息

aDepartment of Medicine, Division of Cardiovascular Diseases, Montefiore Medical Center bDepartment of Epidemiology and Population Health, Albert Einstein College of Medicine, New York, New York cDepartment of Medicine, Cardiovascular Division, Mayo Clinic College of Medicine, Rochester, Minnesota dDepartment of Internal Medicine, Cleveland Clinic, Cleveland, Ohio eDepartment of Anesthesiology and Perioperative Medicine, Division of Cardiovascular and Thoracic Anesthesiology fDepartment of Medicine, Cardiovascular Division, Mayo Clinic College of Medicine, Scottsdale, Arizona, USA gDepartment of Medicine, Cardiovascular Institute, Hospital Clínico San Carlos, Madrid, Spain.

出版信息

Coron Artery Dis. 2017 Aug;28(5):395-405. doi: 10.1097/MCA.0000000000000485.

DOI:10.1097/MCA.0000000000000485
PMID:28328784
Abstract

OBJECTIVE

We carried out a meta-analysis summarizing the efficacy and safety of direct factor Xa inhibitor (DXI) in patients receiving guideline-based antiplatelet therapy (GBAT) after an acute coronary syndrome.

BACKGROUND

Randomized-controlled trials have shown that the addition of a DXI to GBAT after acute coronary syndrome can reduce ischemic events, the trade-off being an increase in major bleeding complications.

METHODS

PubMed, Central, Embase, The Cochrane Register, Google Scholar databases, and the scientific session abstracts were searched for eligible randomized trials from 1 January 1990 through 31 December 2016.

RESULTS

Nine randomized-controlled trials were included in this meta-analysis enrolling a total of 45651 patients. There was a significant reduction in major adverse cardiovascular events with DXIs/GBAT compared with GBAT alone [odds ratio (OR): 0.88; 95% confidence interval (CI): 0.82-0.94, number needed to treat=52]. There were also significant reductions in two individual components of major adverse cardiovascular events: myocardial infarction (OR: 0.89; 95% CI: 0.81-0.98) and stent thrombosis (OR: 0.73; 95% CI: 0.59-0.90), favoring the DXI/GBAT group. There was an increased risk of major bleeding (OR: 2.51; 95% CI: 1.82-3.46) and intracranial hemorrhage (OR: 3.47; 95% CI: 1.76-6.86) compared with GBAT.

CONCLUSION

In acute coronary syndromes, the addition of a DXI to GBAT results in a significant reduction of major adverse cardiovascular events, myocardial infarction, and stent thrombosis, offset by an increased risk of bleeding.

摘要

目的

我们进行了一项荟萃分析,总结直接Xa因子抑制剂(DXI)在急性冠状动脉综合征后接受基于指南的抗血小板治疗(GBAT)患者中的疗效和安全性。

背景

随机对照试验表明,急性冠状动脉综合征后在GBAT基础上加用DXI可减少缺血事件,但代价是主要出血并发症增加。

方法

检索PubMed、Central、Embase、Cochrane注册库、谷歌学术数据库以及科学会议摘要,以查找1990年1月1日至2016年12月31日期间符合条件的随机试验。

结果

该荟萃分析纳入了9项随机对照试验,共纳入45651例患者。与单纯GBAT相比,DXI/GBAT组主要不良心血管事件显著减少[比值比(OR):0.88;95%置信区间(CI):0.82 - 0.94,需治疗人数=52]。主要不良心血管事件的两个单独组成部分也显著减少:心肌梗死(OR:0.89;95% CI:0.81 - 0.98)和支架血栓形成(OR:0.73;95% CI:0.59 - 0.90),有利于DXI/GBAT组。与GBAT相比,主要出血(OR:2.51;95% CI:1.82 - 3.46)和颅内出血(OR:3.47;95% CI:1.76 - 6.86)风险增加。

结论

在急性冠状动脉综合征中,GBAT基础上加用DXI可显著减少主要不良心血管事件、心肌梗死和支架血栓形成,但出血风险增加抵消了这一益处。

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