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[NEJM最新论文]:深静脉血栓形成的导管取栓溶栓治疗
2017年12月13日 时讯速递, 进展交流 暂无评论

ORIGINAL ARTICLE

Pharmacomechanical Catheter-Directed Thrombolysis for Deep-Vein Thrombosis

Suresh Vedantham, Samuel Z. Goldhaber, Jim A. Julian, et al.

N Engl J Med 2017; 377:2240-2252

DOI: 10.1056/NEJMoa1615066

BACKGROUND 背景

The post-thrombotic syndrome frequently develops in patients with proximal deep-vein thrombosis despite treatment with anticoagulant therapy. Pharmacomechanical catheter-directed thrombolysis (hereafter “pharmacomechanical thrombolysis”) rapidly removes thrombus and is hypothesized to reduce the risk of the post-thrombotic syndrome.

近端深静脉血栓患者尽管接受抗凝治疗,但仍然经常发生血栓后综合征。导管取栓溶栓能够迅速清除血栓,理论上可以减少血栓后综合征的风险。

METHODS 方法

We randomly assigned 692 patients with acute proximal deep-vein thrombosis to receive either anticoagulation alone (control group) or anticoagulation plus pharmacomechanical thrombolysis (catheter-mediated or device-mediated intrathrombus delivery of recombinant tissue plasminogen activator and thrombus aspiration or maceration, with or without stenting). The primary outcome was development of the post-thrombotic syndrome between 6 and 24 months of follow-up.

我们将692名急性近端深静脉血栓形成患者随机分为单纯抗凝组(对照组)或抗凝及导管取栓溶栓组(经导管在血栓内给予重组组织纤溶酶原激活物并进行血栓抽吸,放置或不放置支架)。主要预后终点为随访6-24个月间血栓后综合征的发生率。

RESULTS 结果

Between 6 and 24 months, there was no significant between-group difference in the percentage of patients with the post-thrombotic syndrome (47% in the pharmacomechanical-thrombolysis group and 48% in the control group; risk ratio, 0.96; 95% confidence interval [CI], 0.82 to 1.11; P=0.56). Pharmacomechanical thrombolysis led to more major bleeding events within 10 days (1.7% vs. 0.3% of patients, P=0.049), but no significant difference in recurrent venous thromboembolism was seen over the 24-month follow-up period (12% in the pharmacomechanical-thrombolysis group and 8% in the control group, P=0.09). Moderate-to-severe post-thrombotic syndrome occurred in 18% of patients in the pharmacomechanical-thrombolysis group versus 24% of those in the control group (risk ratio, 0.73; 95% CI, 0.54 to 0.98; P=0.04). Severity scores for the post-thrombotic syndrome were lower in the pharmacomechanical-thrombolysis group than in the control group at 6, 12, 18, and 24 months of follow-up (P<0.01 for the comparison of the Villalta scores at each time point), but the improvement in quality of life from baseline to 24 months did not differ significantly between the treatment groups.

随访6-24个月时,患者发生血栓后综合征的比例并无组间差异(导管取栓溶栓组47%,对照组48%;风险比0.96;95%可信区间[CI],0.82-1.11;P=0.56)。导管取栓溶栓10天内出现更多的大出血事件(1.7% vs. 0.3%,P=0.049),但24个月随访期间静脉血栓栓塞复发率并无显著差异(导管取栓溶栓组12%,对照组8%,P=0.09)。导管取栓溶栓组18%的患者以及对照组24%的患者发生中重度血栓后综合征(风险比0.73;95%CI 0.54-0.98;P=0.04)。随访6、12、18和24个月时,导管取栓溶栓组血栓后综合征严重程度评分低于对照组(所有时间点Villalta评分比较P<0.01),但从基线至24个月间两组患者生活质量无显著差异。

CONCLUSIONS 结论

Among patients with acute proximal deep-vein thrombosis, the addition of pharmacomechanical catheter-directed thrombolysis to anticoagulation did not result in a lower risk of the post-thrombotic syndrome but did result in a higher risk of major bleeding. (Funded by the National Heart, Lung, and Blood Institute and others; ATTRACT ClinicalTrials.gov number, NCT00790335.)

对于急性近端深静脉血栓患者,在抗凝治疗基础上进行导管取栓溶栓不能降低血栓后综合征的风险,且增加大出血风险。

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