JAMA可知识更新：回收下腔静脉滤器联合抗凝药物并不能减少反复肺栓塞的风险

pingchi1983

Effect of a retrievable inferior vena cava filter plus anticoagulation vs anticoagulation alone on risk of recurrent pulmonary embolism: a randomized clinical trial.
可回收下腔静脉滤器联合抗凝治疗与单纯抗凝治疗在预防反复肺栓塞风险的效果比较：随机临床试验

目前，一项来自法国的临床研究表明，对于发生急性肺栓塞的住院病人而言，比起单纯使用抗凝治疗的，采用可回收下腔静脉滤器联合药物抗凝并不能减少3个月内再发有症状肺栓塞的风险。这项研究纳入了399个患者，其中200个随机分到联合治疗组，199个随机分到单纯抗凝组，最后联合组有178名接受了长达6个月的随访，单纯治疗组有184名。实验的首要指标是3个月内再发致命的或有症状的肺栓塞病人数，联合组有6人，占3%；而单纯抗凝组仅仅3人，占1.5%，远低于预期的8%；次要指标是6个月内再发致命或不致命的有症状的肺栓塞或者3个月和6个月有深静脉血栓形成。次要指标无明显差异，滤网栓塞发生3例。文章的作者强调给医院放置可回收滤网的技术很成熟，因此不考虑滤网没有发挥过滤血栓作用的可能。

Abstract
IMPORTANCE:

Although retrievable inferior vena cava filters are frequently used in addition to anticoagulation in patients with acute venous thromboembolism, their benefit-risk ratio is unclear.

OBJECTIVE:

To evaluate the efficacy and safety of retrievable vena cava filters plus anticoagulation vs anticoagulation alone for preventing pulmonary embolism recurrence in patients presenting with acute pulmonary embolism and a high risk of recurrence.

DESIGN, SETTING, AND PARTICIPANTS:

Randomized, open-label, blinded end point trial (PREPIC2) with 6-month follow-up conducted from August 2006 to January 2013. Hospitalized patients with acute, symptomatic pulmonary embolism associated with lower-limb vein thrombosis and at least 1 criterion for severity were assigned to retrievable inferior vena cava filter implantation plus anticoagulation (filter group; n = 200) oranticoagulation alone with no filter implantation (control group; n = 199). Initial hospitalization with ambulatory follow-up occurred in 17 French centers.

INTERVENTIONS:

Full-dose anticoagulation for at least 6 months in all patients. Insertion of a retrievable inferior vena cava filter in patients randomized to the filter group. Filter retrieval was planned at 3 months from placement.

MAIN OUTCOMES AND MEASURES:

Primary efficacy outcome was symptomatic recurrent pulmonary embolism at 3 months. Secondary outcomes were recurrent pulmonary embolism at 6 months, symptomatic deep vein thrombosis, major bleeding, death at 3 and 6 months, andfilter complications.

RESULTS:

In the filter group, the filter was successfully inserted in 193 patients and was retrieved as planned in 153 of the 164 patients in whom retrieval was attempted. By 3 months, recurrent pulmonary embolism had occurred in 6 patients (3.0%; all fatal) in the filter group and in 3 patients (1.5%; 2 fatal) in the control group (relative risk with filter, 2.00 [95% CI, 0.51-7.89]; P = .50). Results were similar at 6 months. No difference was observed between the 2 groups regarding the other outcomes. Filter thrombosis occurred in 3 patients.

CONCLUSIONS AND RELEVANCE:

Among hospitalized patients with severe acute pulmonary embolism, the use of a retrievable inferior venacava filter plus anticoagulation compared with anticoagulation alone did not reduce the risk of symptomatic recurrent pulmonary embolism at 3 months. These findings do not support the use of this type of filter in patients who can be treated with anticoagulation.