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继续使用华法林在起搏器或植入式心脏除颤器植入期间:一项随机临床试验。

Continuation of warfarin during pacemaker or implantable cardioverter-defibrillator implantation: a randomized clinical trial.

机构信息

Section of Cardiac Electrophysiology, Division of Cardiology, Johns Hopkins Medical Institutes, Baltimore, Maryland, USA.

出版信息

Heart Rhythm. 2011 Apr;8(4):536-40. doi: 10.1016/j.hrthm.2010.12.016. Epub 2010 Dec 13.

DOI:10.1016/j.hrthm.2010.12.016
PMID:21147261
Abstract

BACKGROUND

Management of oral anticoagulation in patients undergoing pacemaker (PPM) or implantable cardioverter-defibrillator (ICD) implantation remains controversial. Prior studies demonstrate that continuation of warfarin may be safer when compared with strategies requiring interruption and/or heparin bridging. Limited data from randomized trials exist.

OBJECTIVE

We conducted a randomized trial to determine whether warfarin continuation is superior to warfarin interruption during PPM or ICD implantation.

METHODS

Patients on oral anticoagulation referred for PPM or ICD implantation were randomized to warfarin continuation versus interruption. Patients randomized to warfarin interruption were further stratified into two groups based on their risk for thromboembolic events in the absence of warfarin. Moderate-risk patients were randomized to warfarin continuation versus warfarin interruption. High-risk patients were randomized to warfarin continuation versus warfarin interruption with heparin bridging. The primary combined outcome included thromboembolic events, anticoagulant-related complications, or any significant bleeding necessitating additional intervention or discontinuation of anticoagulation.

RESULTS

We studied 100 patients (average age 70.8 years, 21% female, mean body mass index 28.4) who underwent 64 ICD and 36 PPM implantations. Fifty patients were assigned to continue warfarin. The randomized groups were well matched. Among patients randomized to warfarin interruption, there were two pocket hematomas, one pericardial effusion, one transient ischemic attack, and one patient who developed heparin-induced thrombocytopenia. No events were noted among patients continuing warfarin (P = .056).

CONCLUSIONS

While the results were not statistically significant, there was a trend toward reduced complications in patients randomized to warfarin continuation. This strategy should be considered in patients undergoing PPM or ICD implantation.

摘要

背景

接受起搏器(PPM)或植入式心脏复律除颤器(ICD)植入的患者的口服抗凝管理仍然存在争议。先前的研究表明,与需要中断和/或肝素桥接的策略相比,继续使用华法林可能更安全。随机试验的有限数据存在。

目的

我们进行了一项随机试验,以确定在 PPM 或 ICD 植入期间继续使用华法林是否优于中断华法林。

方法

正在接受口服抗凝治疗并接受 PPM 或 ICD 植入的患者被随机分为华法林继续治疗组与华法林中断组。随机分为华法林中断组的患者根据其在无华法林的情况下发生血栓栓塞事件的风险进一步分层为两组。中度风险患者被随机分为华法林继续治疗组与华法林中断组。高风险患者被随机分为华法林继续治疗组与华法林中断组加肝素桥接。主要联合结局包括血栓栓塞事件、抗凝相关并发症或任何需要进一步干预或停止抗凝的明显出血。

结果

我们研究了 100 名患者(平均年龄 70.8 岁,21%为女性,平均体重指数 28.4),他们接受了 64 例 ICD 和 36 例 PPM 植入。50 名患者被分配继续使用华法林。随机分组的患者情况良好匹配。在随机接受华法林中断的患者中,有 2 例袋血肿、1 例心包积液、1 例短暂性脑缺血发作和 1 例发生肝素诱导的血小板减少症患者。继续使用华法林的患者中未观察到任何事件(P =.056)。

结论

虽然结果没有统计学意义,但随机接受华法林继续治疗的患者并发症有减少的趋势。在接受 PPM 或 ICD 植入的患者中,应考虑这种策略。

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