Abstract Body (Do not enter title and authors here): Background: Catheter-directed thrombolysis (CDT) followed by anticoagulation has not demonstrated significant benefits in terms of efficacy and safety in major clinical trials. However, the sub-analysis from those trials on proximal DVT showed conflicting evidence regarding the prevention of post-thrombotic syndrome and patency outcomes.
Hypothesis: Is CDT plus anticoagulation superior to anticoagulation alone in preventing post-thrombotic syndrome and improving vein patency?
Aims: To compare the efficacy of CDT plus anticoagulation to anticoagulation alone in preventing post-thrombotic syndrome and improving vein patency.
Methods: We conducted a comprehensive search in major databases from inception until June 1, 2025. Randomized controlled trials (RCTs) and observational studies comparing CDT plus anticoagulation and anticoagulation alone in proximal deep vein thrombosis were included. We used RevMan 5.4.1 to calculate the pooled risk ratio (RR) with corresponding 95% confidence intervals (CI). A p-value of <0.05 was deemed statistically significant.
Results: A total of 91,912 patients were included across nine studies (five randomized controlled trials and four observational cohorts), with 4,276 patients in the CDT plus anticoagulation group and 87,636 patients in the anticoagulation-alone group. The follow-up duration ranged from 6 to 30 months. Patients who received CDT plus anticoagulation demonstrated a lower incidence of post-thrombotic syndrome compared to those receiving anticoagulation alone; however, this difference did not reach statistical significance (RR, 0.67; 95% CI: 0.44–1.02; I2 = 73%; p = 0.06). In contrast, vein patency was significantly higher in the CDT group (RR, 1.83; 95% CI: 1.07–3.13; I2= 60%; p < 0.05). No significant differences were found between the groups for pulmonary embolism (RR, 1.40; 95% CI: 0.08–24.98; I2 = 97%; p = 0.82) or recurrent VTE/DVT events (RR, 0.69; 95% CI: 0.36–1.32; I2 = 54%; p = 0.27).
Conclusions: This meta-analysis indicates that combining CDT with anticoagulation may enhance vein patency compared to using anticoagulation alone for proximal DVT. While the decrease in post-thrombotic syndrome did not attain statistical significance, a positive trend was noted. There were no substantial differences in rates of recurrence or pulmonary embolism. More high-quality, long-term RCTs are necessary to validate these results and inform clinical practice.