Pharmacomechanical Catheter-Directed Thrombolysis for Deep-Vein Thrombosis.
Pharmacomechanical Catheter-Directed Thrombolysis for Deep-Vein Thrombosis.
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DOI：
10.1056/nejmoa1615066
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发表时间：
2017-12-07
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影响因子：
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通讯作者：
ATTRACT Trial Investigators
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作者：
Vedantham S;Goldhaber SZ;Julian JA;Kahn SR;Jaff MR;Cohen DJ;Magnuson E;Razavi MK;Comerota AJ;Gornik HL;Murphy TP;Lewis L;Duncan JR;Nieters P;Derfler MC;Filion M;Gu CS;Kee S;Schneider J;Saad N;Blinder M;Moll S;Sacks D;Lin J;Rundback J;Garcia M;Razdan R;VanderWoude E;Marques V;Kearon C;ATTRACT Trial Investigators
血栓后综合征经常发生在接受抗凝治疗的近端深静脉血栓形成的患者中。药物机械导管定向溶栓(以下简称“药物机械溶栓”)能迅速清除血栓，并被认为可以降低血栓形成后综合征的风险。我们随机将692例急性近端深静脉血栓形成患者分为两组，一组接受单独抗凝治疗(对照组)，另一组接受抗凝+药物机械溶栓治疗(使用或不使用支架治疗，经导管或装置介导的血栓内注射重组组织型纤溶酶原激活剂和血栓抽吸或浸泡)。主要结果是在6到24个月的随访期内血栓形成后综合征的发展。在6个月到24个月期间，血栓后综合征患者的百分比在组间没有显著差异(药物机械溶栓组和对照组分别为47%和48%；风险比为0.96；95%可信区间[CI]为0.82至1.11；P=0.56)。药物机械溶栓组在10天内发生较多出血事件(1.7%比0.3%，P=0.049)，但24个月内静脉血栓再发的发生率无显著差异(药物机械溶栓组为12%，对照组为8%，P=0.09)。中重度血栓后综合征发生率药物机械溶栓组为18%，对照组为24%(危险度比0.73；95%可信区间0.54~0.98；P=0.04)。在6个月、12个月、18个月和24个月的随访中，药物机械溶栓组血栓后综合征的严重程度评分低于对照组(P<；0.01，比较每个时间点的Villalta评分)，但从基线到24个月的生活质量改善在两组之间没有显著差异。在急性近端深静脉血栓形成的患者中，在抗凝的基础上加入药物机械导管定向溶栓并不会降低血栓后综合征的风险，但确实会导致较高的大出血风险。(由国家心肺血液研究所等资助；吸引临床试验.gov编号，NCT00790335。)
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. 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. 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. 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.)