Background
Current standard therapy for patients with acute proximal deep vein thrombosis (DVT) consists of anticoagulant therapy and graduated elastic compression stockings. Despite use of this strategy, the post-thrombotic syndrome (PTS) develops frequently, causes substantial patient disability, and impairs quality of life (QOL). Pharmacomechanical catheter-directed thrombolysis (PCDT), which rapidly removes acute venous thrombus, may reduce the frequency of PTS. However, this hypothesis has not been tested in a large multicenter randomized trial.
Study Design
The ATTRACT Study is an ongoing NIH-sponsored, Phase III, multicenter, randomized, open-label, assessor-blinded, parallel two-arm, controlled clinical trial. Approximately 692 patients with acute proximal DVT involving the femoral, common femoral, and/or iliac vein are being randomized to receive PCDT + standard therapy versus standard therapy alone. The primary study hypothesis is that PCDT will reduce the proportion of patients who develop PTS within 2 years by one-third, assessed using the Villalta Scale. Secondary outcomes include safety, general and venous disease-specific QOL, relief of early pain and swelling, and cost-effectiveness.
Conclusion
ATTRACT will determine if PCDT should be routinely used to prevent PTS in patients with symptomatic proximal DVT above the popliteal vein.