A clinical trial of vena caval filters in the prevention of pulmonary embolism in patients with proximal deep-vein thrombosis
A clinical trial of vena caval filters in the prevention of pulmonary embolism in patients with proximal deep-vein thrombosis
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DOI：
10.1056/nejm199802123380701
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发表时间：
1998-02-12
影响因子：
158.5
通讯作者：
Simonneau, G
中科院分区：
文献类型：
--
作者：
Decousus, H;Leizorovicz, A;Simonneau, G
背景 腔静脉滤器预防近端深静脉血栓患者肺栓塞的有效性和安全性仍存在争议。方法采用二乘二析因设计，我们将 400 名有肺栓塞风险的近端深静脉血栓患者随机分配接受腔静脉滤器（200 例）或不滤器（200 例），并接受低分子肝素治疗（依诺肝素，195 名患者）或普通肝素（205 名患者）。分析第 12 天和两年后的静脉血栓栓塞复发率、死亡率和大出血率。 结果 在第 12 天，两名分配接受过滤器的患者 (1.1%) 与九名分配不接受过滤器的患者 (4.8%) 相比，曾患有有症状或无症状的肺栓塞（比值比，0.22；95% 置信区间，0.05 至 0.90）。两年时，分配到过滤器组的 37 名患者 (20.8%) 与分配到无过滤器组的 21 名患者 (11.6%) 相比，患有复发性深静脉血栓（比值比，1.87；95% 置信区间，1.10 至 3.20）。死亡率或其他结果没有显着差异。第 12 天时，3 名接受低分子肝素治疗的患者 (1.6%) 与 8 名接受普通肝素治疗的患者 (4.2%) 相比，出现有症状或无症状肺栓塞（优势比为 0.38；95% 置信区间为 0.10 至 1.38）。 结论 在近端深静脉血栓形成的高危患者中，用于预防肺栓塞的腔静脉过滤器被过量的复发性深静脉血栓所抵消，死亡率没有任何差异。我们的数据还证实，低分子量肝素在预防肺栓塞方面与普通肝素一样有效且安全。 (C) 1998 年，马萨诸塞州医学会。
Background The efficacy and safety of vena caval filters in the prevention of pulmonary embolism in patients with proximal deep-vein thrombosis are still a matter of debate.Methods Using a two-by-two factorial design, we randomly assigned 400 patients with proximal deep-vein thrombosis who were at risk for pulmonary embolism to receive a vena caval filter (200 patients) or no filter (200 patients), and to receive low-molecular-weight heparin (enoxaparin, 195 patients) or unfractionated heparin (205 patients). The rates of recurrent venous thromboembolism, death, and major bleeding were analyzed at day 12 and at two years.Results At day 12, two patients assigned to receive filters (1.1 percent), as compared with nine patients assigned to receive no filters (4.8 percent), had-had symptomatic or asymptomatic pulmonary embolism (odds ratio, 0.22; 95 percent confidence interval, 0.05 to 0.90). At two years, 37 patients assigned to the filter group (20.8 percent), as compared with 21 patients assigned to the no-filter group (11.6 percent), had had recurrent deep-vein thrombosis (odds ratio, 1.87; 95 percent confidence interval, 1.10 to 3.20). There were no significant differences in mortality or the other outcomes. At day 12, three patients assigned to low-molecular-weight heparin (1.6 percent), as compared with eight patients assigned to unfractionated heparin (4.2 percent), had had symptomatic or asymptomatic pulmonary embolism (odds ratio, 0.38; 95 percent confidence interval, 0.10 to 1.38).Conclusions In high-risk patients with proximal deep-vein thrombosis, the initial beneficial effect of vena caval filters for the prevention of pulmonary embolism was counterbalanced by an excess of recurrent deep-vein thrombosis, without any difference in mortality. Our data also confirmed that low-molecular-weight heparin was as effective and safe as unfractionated heparin for the prevention of pulmonary embolism. (C) 1998, Massachusetts Medical Society.