by Lynn Shapiro
, Writer | September 15, 2008
FAIRFAX, Va. -- ATTRACT -- the first major national trial of a catheter-based treatment for deep vein thrombosis--will evaluate the use of clot-dissolving drugs in combination with clot removal devices to prevent post-thrombotic syndrome in patients with DVT (the formation of a blood clot in a leg vein). PTS, a common irreversible complication of DVT, causes permanent damage to the veins, resulting in debilitating chronic leg pain, swelling, fatigue and/or skin ulcers. About 25-50 percent of DVT patients develop PTS when treated with blood thinners alone. While early treatment with blood thinners is important to prevent a life-threatening pulmonary embolism, blood thinners alone do not dissolve the existing clot, which remains in the leg. Preliminary studies have shown that interventional clot-busting treatments can-unlike standard DVT therapy-remove clots and have strong potential to prevent PTS. The outcomes of this pivotal multicenter trial-to be funded at more than $10 million by the
National Institutes of Health's National Heart, Lung and Blood Institute (NHLBI)--are likely to change the way DVT is treated in the United States.
"The ATTRACT trial could fundamentally shift the 50-year-old DVT treatment paradigm to one that includes interventional clot removal as an essential element of standard DVT care," said interventional radiologist Suresh Vedantham, M.D., who will lead the trial. "By funding this study, the NHLBI has clearly recognized the strong potential of interventional radiology clot removal treatments for DVT to improve public health," added the associate professor at the Washington University School of Medicine's Mallinckrodt Institute of Radiology in St. Louis, MO.
ATTRACT (Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis) is a multicenter, randomized trial "that will definitively determine if the newest clot-busting treatment (pharmacomechanical catheter-directed thrombolysis or PCDT) prevents post-thrombotic syndrome in patients with DVT," said Vedantham. PCDT combines the use of a clot-dissolving drug with a catheter-mounted miniature clot removal device, allowing an interventional radiologist to break up the clot and remove it from the vein, restoring blood flow. "PTS is a serious complication of DVT that is under recognized and potentially preventable if we are able to dissolve the clots early, before permanent damage to the vein occurs," he noted. "Established PTS is a lifelong, irreversible condition for which there are no consistently effective treatments. Its prevention is extremely important; however, physicians have historically neglected the prevention of PTS," said Vedantham. "The groundbreaking combination of clot-busting drugs with innovative device technology-pioneered by interventional radiologists-now enables clot removal in a safer and more efficient manner, often in a single procedure session. These advances will greatly increase the use of interventional DVT treatments," added Vedantham.