2021-06-17 17:13:55  招生问答

本期文章:《英国医学杂志》:Online/在线发表

术后低分子肝素桥接治疗动脉血栓栓塞高危患者不能临床获益


术后低分子肝素桥接治疗动脉血栓栓塞高危患者不能临床获益

加拿大韦仕敦大学Michael J Kovacs团队研究了术后低分子肝素桥接治疗动脉血栓栓塞高危患者的疗效。2021年6月9日,《英国医学杂志》发表了这一成果。

术后低分子肝素桥接治疗动脉血栓栓塞高危患者不能临床获益

为了确定当华法林暂时中断一个计划疗程时,对于房颤或心脏机械瓣膜患者,达肝素钠术后桥接治疗相对于安慰剂的有效性和安全性,2007年2月至2016年3月,研究组在加拿大和印度的10个血栓研究点进行了一项前瞻性、双盲、随机对照试验。共招募了1471名年龄在18岁及以上、需要暂时中断华法林治疗的房颤或机械性心脏瓣膜患者。

将其随机分配,其中821例接受达肝素钠治疗,有1例在分组后撤出;650例接受安慰剂治疗。主要结局是根据国际血栓和止血学会的标准,在手术后90天内发生重大血栓栓塞(中风、短暂性缺血发作、近端深静脉血栓形成、肺栓塞、心肌梗死、周围栓塞或血管死亡)和大出血事件。

90天内,安慰剂组重大血栓栓塞的发生率为1.2%(650名患者发生8起事件),达肝素钠组为1.0%(820名患者发生8起事件),组间差异不显著。安慰剂组大出血发生率为2.0%(650例患者发生13起事件),达肝素钠组为1.3%(820例患者发生11起事件),差异亦不显著。心房颤动组和心脏机械瓣膜组的结果一致。

研究结果表明,对于心房颤动或机械心脏瓣膜的患者,华法林中断疗程后,术后接受达肝素钠接预防重大血栓栓塞未发现明显获益。

附:英文原文

Title: Postoperative low molecular weight heparin bridging treatment for patients at high risk of arterial thromboembolism (PERIOP2): double blind randomised controlled trial

Author: Michael J Kovacs, Philip S Wells, David R Anderson, Alejandro Lazo-Langner, Clive Kearon, Shannon M Bates, Mark Blostein, Susan R Kahn, Sam Schulman, Elham Sabri, Susan Solymoss, Tim Ramsay, Erik Yeo, Marc A Rodger

Issue&Volume: 2021/06/09

Abstract:

Objective To determine the efficacy and safety of dalteparin postoperative bridging treatment versus placebo for patients with atrial fibrillation or mechanical heart valves when warfarin is temporarily interrupted for a planned procedure.

Design Prospective, double blind, randomised controlled trial.

Setting 10 thrombosis research sites in Canada and India between February 2007 and March 2016.

Participants 1471 patients aged 18 years or older with atrial fibrillation or mechanical heart valves who required temporary interruption of warfarin for a procedure.

Intervention Random assignment to dalteparin (n=821; one patient withdrew consent immediately after randomisation) or placebo (n=650) after the procedure.

Main outcome measures Major thromboembolism (stroke, transient ischaemic attack, proximal deep vein thrombosis, pulmonary embolism, myocardial infarction, peripheral embolism, or vascular death) and major bleeding according to the International Society on Thrombosis and Haemostasis criteria within 90 days of the procedure.

Results The rate of major thromboembolism within 90 days was 1.2% (eight events in 650 patients) for placebo and 1.0% (eight events in 820 patients) for dalteparin (P=0.64, risk difference 0.3%, 95% confidence interval 1.3 to 0.8). The rate of major bleeding was 2.0% (13 events in 650 patients) for placebo and 1.3% (11 events in 820 patients) for dalteparin (P=0.32, risk difference 0.7, 95% confidence interval 2.0 to 0.7). The results were consistent for the atrial fibrillation and mechanical heart valves groups.

Conclusions In patients with atrial fibrillation or mechanical heart valves who had warfarin interrupted for a procedure, no significant benefit was found for postoperative dalteparin bridging to prevent major thromboembolism.

DOI: 10.1136/bmj.n1205

Source: https://www.bmj.com/content/373/bmj.n1205

期刊信息

BMJ-British Medical Journal:《英国医学杂志》,创刊于1840年。隶属于BMJ出版集团,最新IF:27.604 官方网址: 投稿链接:https://mc.manuscriptcentral.com/bmj

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