A Multicenter Trial of Vena Cava Filters in Severely Injured Patients
Kwok M. Ho, Sudhakar Rao, Stephen Honeybul, et al
N Engl J Med 2019; 381:328-337
DOI: 10.1056/NEJMoa1806515
Abstract
BACKGROUND 背景
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.
对于具有预防性抗凝禁忌的严重创伤患者，早期置入下腔静脉滤器能否降低肺动脉栓塞或死亡风险尚不明确。
METHODS 方法
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.
在这项多中心随机对照试验中，我们将240名有抗凝药物禁忌的严重创伤（ISS评分> 15分[分值0-75，分值越高创伤越严重]）患者随机分组，在因创伤入院后最初72小时内置入腔静脉滤器，或不放置滤器。主要预后终点为入选后90天内有症状的肺动脉栓塞或全因死亡；次要预后终点为存活至少7天且最初7天内未接受预防性抗凝的患者亚组第8天至第90天有症状肺动脉栓塞。所有患者在2周时均进行下肢超声检查；满足预先确定标准的患者必须接受CT肺动脉造影。
RESULTS 结果
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.
患者中位年龄39岁，ISS评分中位数为27分。与不放置滤器相比，早期放置腔静脉滤器不能减少有症状肺动脉栓塞或死亡（腔静脉滤器组13.9%，对照组14.4%；风险比，0.99; 95% 可信区间 [CI], 0.51 to 1.94; P=0.98）。腔静脉滤器组46名患者及对照组34名患者创伤后7天内未接受预防性抗凝，腔静脉组没有患者发生肺动脉栓塞，对照组5名患者(14.7%)发生肺动脉栓塞，包括1名患者死亡（肺栓塞相对危险度，0; 95% CI, 0.00 to 0.55）。6名患者的滤器上发现血栓。
CONCLUSIONS 结论
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.
与严重创伤后不放置滤器相比，早期预防性放置腔静脉滤器不能减少90天内有症状肺动脉栓塞或死亡。
(Funded by the Medical Research Foundation of Royal Perth Hospital and others; Australian New Zealand Clinical Trials Registry number, ACTRN12614000963628.)
评论[仅代表个人观点]
- 请注意方法学中的部分细节
- 所有患者均使用腔静脉临时滤器。一旦可以开始预防性抗凝或到伤后90天，即可根据患者具体情况决定是否去除滤器
- 尽管入选时要求患者具有抗凝禁忌，但根据病程变化，可尽快开始预防性抗凝
- 所有患者健侧下肢使用间歇性气动加压泵预防血栓形成
- 以上措施是否能够解释研究的阴性结果？
- 澳洲人又一个阴性结果的RCT。如此多的阴性结果，是否说明证实某种治疗效果的意愿过于迫切？私下里想，被人称为trialist不一定是褒奖。
