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Long-Term Outcome After Additional Catheter-Directed Thrombolysis Versus Standard Treatment for Acute Iliofemoral Deep Vein Thrombosis (the CaVenT Study): A Randomised Controlled Trial
Study Questions:
What is the impact of catheter-directed thrombolysis (CDT) using alteplase on development of post-thrombotic syndrome in patients with deep vein thrombosis (DVT)?
Methods:
The CaVenT study authors reported the results of this open-label, randomized, controlled trial, with patients recruited from 20 hospitals in Norway. Patients (ages 18-75 years) with a first-time iliofemoral DVT of 21 days or less were randomized to conventional therapy or conventional therapy plus CDT. Randomization was stratified for involvement of the pelvic veins. The two co-primary outcomes were Villalta score at 24 months, and iliofemoral patency after 6 months.
Results:
The study enrolled 209 patients and randomized 108 to control and 101 to CDT. Follow-up data at 2 years were available for 90% of the cohort. Post-thrombotic syndrome was reduced from 55.6% in the control arm to 41.1% in the treatment arm (p = 0.047) with an absolute risk reduction of 14.4% (95% confidence interval [CI], 0.2-27.9), and the number needed to treat being 7 (95% CI, 4-502). Iliofemoral patency after 6 months was higher in the CTD arm (65.9% vs. 47.4%, p = 0.012). There were 20 bleeding complications related to CDT, of which three were major and five were clinically relevant bleeds. The major bleeding events included one abdominal wall hematoma necessitating blood transfusion, one compartment syndrome of the calf needing surgery, and one inguinal puncture site hematoma.
Conclusions:
The authors concluded that CDT is beneficial in patients with a high proximal DVT and low risk of bleeding.
Perspective:
This study demonstrates a small, but significant reduction in post-thrombotic disorder in patients with proximal DVT. While encouraging, and strongly supportive of use of CDT in these patients, the high rate of post-thrombotic disorder (41% at 2 years) in the active arm suggests the need for further study to help reduce this debilitating complication of DVT.
Keywords: Risk, Follow-Up Studies, Norway, Postthrombotic Syndrome, Norepinephrine, Hematoma, Angioplasty, Balloon, Coronary, Blood Transfusion, Compartment Syndromes, Punctures, Iliac Vein, Catheterization, Venous Thrombosis, Confidence Intervals, Abdominal Wall, Infusions, Intravenous, Tissue Plasminogen Activator, Upper Extremity, Hemorrhage
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