Using a clot-busting mechanical device in combination with thrombolytic drugs for the comprehensive treatment of deep vein thrombosis is faster, more effective, and safer than using thrombolytics alone, according to the largest trial to date. Results were released Sunday at the 2008 Society of Interventional Radiology meeting in Washington, DC.
Deep vein thrombosis of the femoral and popliteal veins can lead to ulceration of the limbs and, in more extreme cases, to pulmonary embolism, which kills about 200,000 patients annually in the U.S. DVT can also affect veins in the pelvis and arms. The current standard of care, catheter-directed thrombolysis, entails the use of a clot-dissolving drug and can take up to three days to be effective.
Isolated thrombolysis — mechanical thrombectomy plus thrombolytic drugs — can get rid of clots in just a few hours, restore vein blood flow, relieve pain and other symptoms, and prevent future clotting, said principal investigator Dr. Gerard J. O'Sullivan, an interventional radiologist at University College Hospital in Galway, Ireland.
"This interventional radiology procedure could really change the way DVT patients are treated and should become a standard of care," he said.
O'Sullivan and coauthor Dr. Mahmood K. Rahzavi, an interventionalist at St. Joseph Hospital in Orange County, CA, reviewed a voluntary patient registry sponsored by the manufacturer of the Trellis peripheral infusion system (Bacchus Vascular, Santa Clara, CA). The registry included 777 patients with lower and upper extremity DVT who were treated at four centers worldwide from Feb. 2005 to Feb 2008.
The authors have no financial relationship with the firm, O'Sullivan said.
A total of 827 limbs with acute (28%), acute/chronic (44%), subacute (11%), subacute/chronic (12%), and chronic (6%) DVT were treated with Trellis-based isolated thrombolysis. The approach achieved significant or total thrombus removal in approximately 97% of acute patients. Almost all other subgroups achieved more than 90% treatment success.
Treatment with the mechanical thrombectomy device does not require general anesthesia and can be performed in less than two hours on average, O'Sullivan said. Because it requires lower doses of thrombolytic drugs, it can reduce risk of bleeding and other complications as well as overall treatment costs.
"This is a very significant advance in DVT treatment, which hasn't changed in more than 40 years," O'Sullivan said. "It's a shift of thinking and is going to change the way DVT is treated."
Combined approach boost deep vein thrombosis cure
Mechanically assisted thrombolysis boost thrombosis therapy
Report from SIR: Minimallly invasive therapies break through in DVT
