Department of Cardiovascular Medicine, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.
PLoS One. 2018 Sep 25;13(9):e0204594. doi: 10.1371/journal.pone.0204594. eCollection 2018.
Small randomized controlled studies and meta-analyses have shown that thrombolysis, especially catheter-directed thrombolysis, can reduce the incidence of post-thrombotic syndrome (PTS). However, the recent ATTRACT trial did not demonstrate the same effects. Given this confusing situation, we performed an updated meta-analysis of randomized controlled trials (RCTs) to evaluate the effects of thrombolysis, especially catheter-directed thrombolysis, on the outcomes of deep venous thrombosis (DVT).
We searched PubMed, Embase, and the Cochrane Library for relevant studies comparing thrombolysis in combination with anticoagulation and with anticoagulation alone. The primary endpoint was PTS during the longest follow-up period. The safety endpoint was the incidence of major bleeding events. We also evaluated the outcomes of catheter-directed thrombolysis as a subgroup analysis.
Six RCTs, including 1418 patients with DVT, were included in our meta-analysis. Thrombolysis in combination with anticoagulation did not reduce PTS (RR: 0.90, [0.80-1.01], P = 0.19) and increased major bleeding (RR: 2.07, [1.12-3.81], P = 0.02). However, trial sequential analysis (TSA) showed that more patients are needed to support the conclusion that thrombolysis in combination with anticoagulation increased major bleeding. Catheter-directed thrombolysis did not reduce the incidence of PTS (RR: 0.88, [0.68-1.13], P = 0.31) and did increase the incidence of major bleeding events (RR: 1.89, [1.00-3.59], P = 0.05).
Thrombolysis, including catheter-directed thrombolysis, did not reduce the incidence of PTS and increased the incidence of major bleeding. However, the results were not supported by TSA and sensitivity analysis, so more relevant studies are needed.
小型随机对照研究和荟萃分析表明,溶栓治疗,尤其是导管定向溶栓治疗,可以降低血栓后综合征(PTS)的发生率。然而,最近的 ATTRACT 试验并未显示出相同的效果。鉴于这种令人困惑的情况,我们对随机对照试验(RCT)进行了更新的荟萃分析,以评估溶栓治疗,尤其是导管定向溶栓治疗对深静脉血栓形成(DVT)结局的影响。
我们检索了 PubMed、Embase 和 Cochrane 图书馆中比较溶栓联合抗凝治疗与单纯抗凝治疗的相关研究。主要终点是最长随访期间的 PTS 发生率。安全性终点是主要出血事件的发生率。我们还评估了导管定向溶栓治疗的结果作为亚组分析。
我们的荟萃分析纳入了 6 项 RCT,共 1418 例 DVT 患者。溶栓联合抗凝治疗并未降低 PTS 发生率(RR:0.90,[0.80-1.01],P=0.19),反而增加了大出血事件的发生率(RR:2.07,[1.12-3.81],P=0.02)。然而,试验序贯分析(TSA)表明,需要更多的患者来支持溶栓联合抗凝治疗增加大出血的结论。导管定向溶栓治疗并未降低 PTS 发生率(RR:0.88,[0.68-1.13],P=0.31),反而增加了大出血事件的发生率(RR:1.89,[1.00-3.59],P=0.05)。
溶栓治疗,包括导管定向溶栓治疗,并未降低 PTS 的发生率,反而增加了大出血的发生率。然而,这些结果并未得到 TSA 和敏感性分析的支持,因此需要更多的相关研究。