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噻氯匹定与口服抗凝药用于冠状动脉支架置入术的比较

Ticlopidine versus oral anticoagulation for coronary stenting.

作者信息

Cosmi B, Rubboli A, Castelvetri C, Milandri M

机构信息

Division of Angiology Department of Cardiovascular Diseases, University of Bologna, University Hospital S.Orsola-Malpighi, via Massarenti 9, Bologna, Italy, 40138.

出版信息

Cochrane Database Syst Rev. 2001;2001(4):CD002133. doi: 10.1002/14651858.CD002133.

Abstract

BACKGROUND

A 2-4 week course of ticlopidine plus aspirin following coronary stenting is considered effective in preventing thrombotic occlusion of the stented vessel and safe in regards to bleeding and peripheral vascular complications. However, rare, although potentially life-threatening haematological complications have been reported with this drug regimen.

OBJECTIVES

To evaluate the efficacy and safety of ticlopidine plus aspirin versus oral anticoagulants after coronary stenting

SEARCH STRATEGY

Electronic search of the Cochrane Library, Medline, Embase from 1991 to June 1999; references from trials and experts.

SELECTION CRITERIA

Randomised controlled trials comparing ticlopidine plus aspirin versus oral anticoagulants (either with or without aspirin) after elective or bail out coronary stenting.

DATA COLLECTION AND ANALYSIS

Three reviewers assessed trial quality and compiled data on outcomes including: total mortality, non fatal myocardial infarction and revascularization occurring within the first 30 days after hospitalization, stent thrombosis on angiography, major and minor bleeding, neutropenia, thrombocytopenia, thrombotic thrombocytopenic purpura.

MAIN RESULTS

Four trials (n=2436 patients) were included. Ticlopidine plus aspirin compared to oral anticoagulants significantly reduced the risk of non-fatal acute myocardial infarction and revascularization at 30 days, combined negative events (mortality, myocardial infarction, revascularization at 30 days) (RR: 0.41; 95% CI: 0.25-0.69; NNT for 30 days: 22; 95% CI: 14-45), and major bleeding (RR in high quality studies: 0.24; 95% CI: 0.07-0.79). Ticlopidine plus aspirin compared to oral anticoagulants significantly increased the risk of eutropenia, thrombocytopenia and neutropenia (RR 5; 95% CI: 1.08-13.07; NNT for 30 days: 142; 95% CI: 76-1000). Ticlopidine plus aspirin vs oral anticoagulation did not affect all cause mortality. Ticlopidine plus aspirin significantly reduced the risk of stent thrombosis (angiography) which was seen only on studies with blinded outcome assessment (RR: 0.14; 95% CI: 0.03-0.60; NNT for 30 days: 33; 95% CI:16-166). Minor bleeding was reported only in one study and no studies recorded thrombotic thrombocytopenic purpura (TTP).

REVIEWER'S CONCLUSIONS: Ticlopidine plus aspirin after coronary stenting is effective in reducing the risk of the revascularization, non fatal myocardial infarction and bleeding complications when compared with oral anticoagulants. No effect is observed on total mortality. However, the haematological side effects of ticlopidine are still a matter of concern, and strict monitoring of blood-cell counts is recommended. Physicians should also be aware of the possibility of rare although potentially life-threatening complications such as TTP

摘要

背景

冠状动脉支架置入术后,为期2 - 4周的噻氯匹定加阿司匹林治疗方案被认为可有效预防支架血管的血栓闭塞,且在出血及外周血管并发症方面较为安全。然而,有报道称这种药物治疗方案会引发罕见但可能危及生命的血液学并发症。

目的

评估冠状动脉支架置入术后噻氯匹定加阿司匹林与口服抗凝剂相比的疗效和安全性。

检索策略

对1991年至1999年6月期间的Cochrane图书馆、Medline、Embase进行电子检索;检索试验及专家提供的参考文献。

入选标准

比较择期或补救性冠状动脉支架置入术后噻氯匹定加阿司匹林与口服抗凝剂(无论是否联用阿司匹林)的随机对照试验。

数据收集与分析

三名评价者评估试验质量,并汇总以下结局的数据:总死亡率、住院后30天内发生的非致命性心肌梗死和血运重建、血管造影显示的支架血栓形成、严重及轻微出血、中性粒细胞减少、血小板减少、血栓性血小板减少性紫癜。

主要结果

纳入四项试验(n = 2436例患者)。与口服抗凝剂相比,噻氯匹定加阿司匹林显著降低了30天时非致命性急性心肌梗死和血运重建的风险、联合阴性事件(死亡率、心肌梗死、30天时血运重建)(RR:0.41;95% CI:0.25 - 0.69;30天的需治疗人数:22;95% CI:14 - 45)以及严重出血(高质量研究中的RR:0.24;95% CI:0.07 - 0.79)。与口服抗凝剂相比,噻氯匹定加阿司匹林显著增加了白细胞减少、血小板减少和中性粒细胞减少的风险(RR 5;95% CI:1.08 - 13.07;30天的需治疗人数:142;95% CI:76 - 1000)。噻氯匹定加阿司匹林与口服抗凝治疗相比,对全因死亡率无影响。噻氯匹定加阿司匹林显著降低了支架血栓形成(血管造影)的风险,这仅在结局评估为盲法的研究中可见(RR:0.14;95% CI:0.03 - 0.60;30天的需治疗人数:33;95% CI:16 - 166)。仅在一项研究中报告了轻微出血,且无研究记录血栓性血小板减少性紫癜(TTP)。

评价者结论

冠状动脉支架置入术后,与口服抗凝剂相比,噻氯匹定加阿司匹林可有效降低血运重建、非致命性心肌梗死及出血并发症的风险。对总死亡率无影响。然而,噻氯匹定的血液学副作用仍值得关注,建议严格监测血细胞计数。医生还应意识到存在罕见但可能危及生命的并发症,如TTP的可能性。

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