ABSTRACT
David Dexter, MD
Assistant Professor of Surgery
Eastern Virginia Medical School
Norfolk, Virginia, United States
The DEXTERITY-AFP (Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation after Thrombus Removal to Yield Benefit in Acute Femoropopliteal DVT) trial was designed to examine the micro-infusion of dexamethasone as a non-specific anti-inflammatory drug in an attempt to reduce the inflammatory surge in the peri-procedural time course.. The study is designed with a single arm of 20 participants each receiving dexamethasone, followed by 60 participants randomized 1:1 to receive the peri-venous steroid or saline injections, each through the Bullfrog Micro-Infusion Device (Mercator MedSystems, San Leandro, Calif.) Participants are chosen with a requirement of DVT involvement in their femoropopliteal vein segment, with or without iliac thrombosis as well. Ten subjects have been enrolled and the one-month results from the first 9 subjects are presented here.
Results:
Median Marder Score of the first 9 subjects was 14 (IQR: 10-22). Dexamethasone delivery was performed in the same care setting as thrombectomy. Four of the nine participants also had iliac stents deployed after the steroid injection. A median vein length of 40cm (IQR: 35-50cm) was treated with dexamethasone, using a median dose of 48mg (IQR: 42-51mg) and a concentration of 3.2mg/mL after 20% dilution with contrast medium to track delivery. Median one-month follow-up was performed 36 days (range: 28-41 days) after thrombectomy and dexamethasone delivery. From baseline to one month, median Villalta score improved by 4 points (IQR: 2-5) from a median of 7 (IQR: 7-8) to median of 3 (IQR: 3-3) and median 10-point pain score improved by 3 (IQR: 1-3) from median 3 (IQR: 2-5) to median 0 (IQR: 0-1). In 8 of the 9 participants (89%), duplex ultrasound scans at one month revealed fully compressible common femoral vein, while 1 of 9 had partial compressibility but maintained patency of the common femoral vein.
Conclusions:
Perivenous anti-inflammatory therapy is a novel treatment for deep vein thrombosis that, when combined with recanalization procedures, has the potential to improve long-term outcomes by reducing vein and venous valve fibrosis. The DEXTERITY-AFP trial has been designed to determine long-term outcomes first in an open-label trial and second in a double-blind randomized controlled trial.