ATTRACT
Trial question
What is the role of pharmacomechanical catheter-directed thrombolysis in reducing the risk of post-thrombotic syndrome in patients with proximal DVT despite treatment with anticoagulant therapy?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
38.0% female
62.0% male
N = 692
692 patients (265 female, 426 male)
Inclusion criteria: patients with proximal DVT despite treatment with anticoagulant therapy
Key exclusion criteria: < 16 or > 75 years of age, pregnant, symptoms for > 14 days, high risk bleeding, active cancer, established post-thrombotic syndrome, or ipsilateral DVT in the previous 2 years
Interventions
N=337 pharmacomechanical-thrombolysis (catheter-mediated or device-mediated intrathrombus delivery of rtPA and thrombus aspiration or maceration, with or without stenting plus anticoagulation)
N=355 medical therapy (anticoagulation alone)
Primary outcome
Rate of post-thrombotic syndrome between 6 and 24 months
47
48
48.0 %
36.0 %
24.0 %
12.0 %
0.0 %
Pharmacomechanical-thrombolysis
Medical therapy
No significant difference ↔
No significant difference in the rate of post-thrombotic syndrome between 6 and 24 months (47% vs. 48%; RR 0.96, 96% CI 0.82 to 1.11)
Secondary outcomes
Significant decrease in moderate-to-severe post-thrombotic syndrome (18% vs. 24%; RR 0.73, 95% CI 0.54 to 0.98)
Safety outcomes
No significant difference in death and major bleeding over 24 months.
Significant differences in major bleeding during the first 10 days (1.7% vs. 0.3%; p = 0.049; RR 6.18, 95% CI 0.78-49.2) and recurrent VTE within 24 months (12% vs. 8%, p = 0.09).
Conclusion
In patients with proximal DVT despite treatment with anticoagulant therapy, pharmacomechanical-thrombolysis were not superior to medical therapy with respect to the rate of post-thrombotic syndrome between 6 and 24 months.
Reference
Vedantham S, Goldhaber SZ, Julian JA et al. Pharmacomechanical Catheter-Directed Thrombolysis for Deep-Vein Thrombosis. N Engl J Med. 2017 Dec 7;377(23):2240-2252.
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