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Meta-Analysis
. 2018 Sep 25;13(9):e0204594.
doi: 10.1371/journal.pone.0204594. eCollection 2018.

Effects of thrombolysis on outcomes of patients with deep venous thrombosis: An updated meta-analysis

Zhenhua Xing  1 , Liang Tang  1 , Zhaowei Zhu  1 , Xinqun Hu  1
Affiliations
Meta-Analysis

Effects of thrombolysis on outcomes of patients with deep venous thrombosis: An updated meta-analysis

Zhenhua Xing et al. PLoS One. .

Abstract

Background: 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).

Methods: 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.

Results: 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).

Conclusion: 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.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Flow diagram of literature searched for review.
Fig 2
Fig 2. Thrombolysis + anticoagulation group vs. anticoagulation-only group on the outcomes of PTS.
Fig 3
Fig 3. Thrombolysis + anticoagulation group vs. anticoagulation-only group on the outcomes of major bleeding.
Fig 4
Fig 4. Trial sequential analysis (TSA) for the outcome of major bleeding.
The cumulative Z-curve crossed the traditional boundary (P = 0.05) but not the TSA boundary, indicating a lack of firm evidence for a 25% reduction in major bleeding with anticoagulation only compared with thrombolysis in combination with anticoagulation. The required sample size is based on an anticipated intervention effect of a 25% relative risk reduction, a control event proportion estimated from the cumulative traditional event proportion, and a diversity of 25%, α = 0.05, and β = 0.20.
Fig 5
Fig 5
A) catheter-directed thrombolysis + anticoagulation group vs. anticoagulation-only group on the outcomes of PTS; B) catheter-directed thrombolysis + anticoagulation group vs. anticoagulation-only group on the outcomes of major bleeding.
See this image and copyright information in PMC

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