单次静脉注射肝素在减少诊断性血管造影期间鞘管血栓形成中的疗效：一项随机对照试验。

Efficacy of a single dose intravenous heparin in reducing sheath-thrombus formation during diagnostic angiography: A randomized controlled trial.

作者信息

Alamri Hussein S, Almoghairi Abdulrahman M, Alghamdi Abdullah A, Almasood Ali S, Alotaiby Mohamed A, Kazim Hameedullah M, Almutairi Meshal, Alanazi Aziz

机构信息

Prince Sultan Cardiac Center, The Military Hospital, Riyadh.

出版信息

J Saudi Heart Assoc. 2012 Jan;24(1):3-7. doi: 10.1016/j.jsha.2011.07.003. Epub 2011 Oct 21.

DOI:10.1016/j.jsha.2011.07.003

PMID:23960661

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3727498/

Abstract

BACKGROUND

Femoral arterial sheath thrombosis and distal embolization are well-recognized complications of cardiac catheterization but the occlusion is extremely rare. Heparinized saline flushes are used during diagnostic coronary angiography to prevent thrombus formation within the sheath lumen. However, the use of prophylactic intravenous heparin following the femoral arterial sheath insertion is controversial. The aim of this study is to evaluate the effectiveness of 2000 units of intravenous heparin bolus in comparison to a saline placebo on the thrombus formation within the arterial sheath during the diagnostic coronary angiography.

METHODS

Eligible patients were randomized to receive either a study drug or placebo at the time of femoral sheath insertion. The sheath was aspirated and flushed for any presence of thrombus after each catheter exchange and at the end of the procedure. Five milliliters of blood were extracted and visualized on clean gauze followed by a saline flush. The primary end-point was the effectiveness of the study drug on reducing the incidence of sheath-thrombus formation.

RESULTS

Three hundred and twenty patients were randomized into two arms. Three hundred and four patients were analyzed: 147 patients in heparin arm and 157 patients in placebo arm after exclusion of 13 patients in heparin arm and three in placebo arm because of incomplete reports. The baseline characteristics were similar and sheath-thrombi formation was observed in 20% of the total cohort. Of the heparin arm, 12% (19 patients) developed sheath-thrombus formation, whereas 26% (42 patients) in the placebo arm, p-value = 0.002. An adjusted logistic regression model showed that the only predictor for the sheath-thrombus formation was the study drug (i.e. heparin). The odds ratio of developing a thrombus in the control arm was 2.5 (95% CI: 1.4-4.5, p = 0.003). There were no bleeding events observed.

CONCLUSION

The risk of thrombus formation is significant and intravenous heparin significantly reduced thrombus formation during diagnostic coronary angiography, with no excess bleeding events.

摘要

背景

股动脉鞘管血栓形成和远端栓塞是心脏导管插入术公认的并发症，但闭塞极为罕见。在诊断性冠状动脉造影期间使用肝素盐水冲洗以防止鞘管腔内形成血栓。然而，在股动脉鞘管插入后使用预防性静脉肝素存在争议。本研究的目的是评估与生理盐水安慰剂相比，2000单位静脉推注肝素对诊断性冠状动脉造影期间动脉鞘管内血栓形成的有效性。

方法

符合条件的患者在股动脉鞘管插入时随机接受研究药物或安慰剂。每次更换导管后以及手术结束时，抽吸鞘管并冲洗以检查是否存在血栓。抽取5毫升血液并在干净纱布上观察，然后用盐水冲洗。主要终点是研究药物降低鞘管血栓形成发生率的有效性。

结果

320例患者随机分为两组。排除肝素组13例和安慰剂组3例因报告不完整后，对304例患者进行分析：肝素组147例，安慰剂组157例。基线特征相似，整个队列中有20%观察到鞘管血栓形成。肝素组中，12%（19例患者）发生鞘管血栓形成，而安慰剂组为26%（42例患者），p值 = 0.002。调整后的逻辑回归模型显示，鞘管血栓形成的唯一预测因素是研究药物（即肝素）。对照组发生血栓的比值比为2.5（95%可信区间：1.4 - 4.5，p = 0.003）。未观察到出血事件。