多中心严重创伤患者腔静脉滤器置入试验

A Multicenter Trial of Vena Cava Filters in Severely Injured Patients.

机构信息

From the Departments of Intensive Care Medicine (K.M.H., J.C.), Neurosurgery (S.H.), and Radiology (P.M.), the State Trauma Unit (S.R., R.Z., C.F.), and the Centre for Implant Technology and Retrieval Analysis, Department of Medical Engineering and Physics (A.K.), Royal Perth Hospital, the Schools of Population and Global Health (K.M.H.), Allied Health (E.G.), and Medicine and Pharmacology (B.W., T.C.), University of Western Australia, and the School of Veterinary and Life Sciences (K.M.H.) and the Western Australian Centre for Thrombosis and Haemostasis (R.I.B.), Murdoch University, Perth, WA, the Departments of Neurosurgery (S.H.) and Intensive Care Medicine (B.W.), Sir Charles Gairdner Hospital, Nedlands, WA, Critical Care Services, Royal Brisbane and Women's Hospital and University of Queensland, Brisbane (J.L., A.H.), and the Department of Intensive Care Medicine, Fiona Stanley Hospital, Murdoch, WA (C.E.) - all in Australia; and Trauma Services, Lancaster General Hospital, University of Pennsylvania, Lancaster (F.B.R.).

出版信息

N Engl J Med. 2019 Jul 25;381(4):328-337. doi: 10.1056/NEJMoa1806515. Epub 2019 Jul 7.

DOI:10.1056/NEJMoa1806515

PMID:31259488

Abstract

BACKGROUND

Whether early placement of an inferior vena cava filter reduces the risk of pulmonary embolism or death in severely injured patients who have a contraindication to prophylactic anticoagulation is not known.

METHODS

In this multicenter, randomized, controlled trial, we assigned 240 severely injured patients (Injury Severity Score >15 [scores range from 0 to 75, with higher scores indicating more severe injury]) who had a contraindication to anticoagulant agents to have a vena cava filter placed within the first 72 hours after admission for the injury or to have no filter placed. The primary end point was a composite of symptomatic pulmonary embolism or death from any cause at 90 days after enrollment; a secondary end point was symptomatic pulmonary embolism between day 8 and day 90 in the subgroup of patients who survived at least 7 days and did not receive prophylactic anticoagulation within 7 days after injury. All patients underwent ultrasonography of the legs at 2 weeks; patients also underwent mandatory computed tomographic pulmonary angiography when prespecified criteria were met.

RESULTS

The median age of the patients was 39 years, and the median Injury Severity Score was 27. Early placement of a vena cava filter did not result in a significantly lower incidence of symptomatic pulmonary embolism or death than no placement of a filter (13.9% in the vena cava filter group and 14.4% in the control group; hazard ratio, 0.99; 95% confidence interval [CI], 0.51 to 1.94; P = 0.98). Among the 46 patients in the vena cava filter group and the 34 patients in the control group who did not receive prophylactic anticoagulation within 7 days after injury, pulmonary embolism developed in none of those in the vena cava filter group and in 5 (14.7%) in the control group, including 1 patient who died (relative risk of pulmonary embolism, 0; 95% CI, 0.00 to 0.55). An entrapped thrombus was found in the filter in 6 patients.

CONCLUSIONS

Early prophylactic placement of a vena cava filter after major trauma did not result in a lower incidence of symptomatic pulmonary embolism or death at 90 days than no placement of a filter. (Funded by the Medical Research Foundation of Royal Perth Hospital and others; Australian New Zealand Clinical Trials Registry number, ACTRN12614000963628.).

摘要

背景

对于有抗凝禁忌的严重创伤患者，早期放置下腔静脉滤器是否能降低肺栓塞或死亡的风险尚不清楚。

方法

在这项多中心、随机、对照试验中，我们将 240 名严重创伤患者（损伤严重程度评分>15 分[评分范围为 0 至 75 分，评分越高表示损伤越严重]）分为两组，一组在受伤后 72 小时内放置下腔静脉滤器，另一组不放置滤器。主要终点是在入组后 90 天内出现有症状的肺栓塞或任何原因导致的死亡的复合终点；次要终点是在至少存活 7 天且在受伤后 7 天内未接受预防性抗凝治疗的患者亚组中，第 8 天至第 90 天之间出现有症状的肺栓塞。所有患者在受伤后 2 周时均接受腿部超声检查；当符合规定标准时，患者还接受强制性计算机断层肺动脉造影。

结果

患者的中位年龄为 39 岁，损伤严重程度评分为 27 分。早期放置下腔静脉滤器与不放置滤器相比，并未显著降低有症状的肺栓塞或死亡的发生率（滤器组为 13.9%，对照组为 14.4%；危险比，0.99；95%置信区间[CI]，0.51 至 1.94；P=0.98）。在滤器组的 46 名和对照组的 34 名未在受伤后 7 天内接受预防性抗凝治疗的患者中，滤器组无一例发生肺栓塞，对照组有 5 例（14.7%）发生肺栓塞，包括 1 例死亡（肺栓塞的相对风险，0；95%CI，0.00 至 0.55）。6 例患者的滤器中发现有嵌顿血栓。