Study Casts Doubt on Costly Treatment for Leg Clots
TUESDAY, July 22, 2014 -- Two treatments that break up blood clots deep in the veins of the legs appear no different in terms of death risk. However, one results in a greater risk of bleeding and average hospitalization bills that are three times the cost of the other treatment, a new study finds.
The standard treatment for these clots -- known as deep vein thrombosis (DVT) -- is blood-thinning medications and compression stockings. The other, more expensive treatment delivers medication directly to the clot to dissolve it. This procedure, called catheter-directed thrombolysis, has increased in use in recent years despite inconclusive research as to its safety, the study authors said.
"DVT is a very common disease that occurs in about one in 1,000 people per year," said lead researcher Dr. Riyaz Bashir, an associate professor of medicine at Temple University School of Medicine in Philadelphia.
"This condition is responsible for more than 600,000 hospitalizations each year in the United States, and approximately 6 percent of these patients will die within one month of the diagnosis," he said.
About 20 percent to 50 percent of people with deep vein thrombosis develop a serious complication called post-thrombotic syndrome, despite conventional treatment with blood-thinning medications and compression stockings, Bashir said. The patients experience chronic leg pains, swelling, skin discoloration and ulcers.
"Many of these people lose their jobs because of the disability it causes," Bashir added.
Dr. Gregg Fonarow, a professor of cardiology at the University of California, Los Angeles, said several small studies have suggested that use of catheter-directed thrombolysis may lead to a decrease in risk for post-thrombotic syndrome.
"However, none of these studies have been definitive," Fonarow said. "Guideline recommendations regarding catheter-delivered thrombolysis are mixed, and use in clinical practice is modest and varies substantially by hospital," he added.
For the new study, published online July 21 in JAMA Internal Medicine, Bashir's team collected data on more than 90,600 patients hospitalized for deep vein thrombosis from 2005 through 2010.
About 4 percent of these patients underwent catheter-directed thrombolysis and also received blood-thinning drugs, the researchers found.
Over the study period, use of the catheter procedure more than doubled -- increasing from a little more than 2 percent in 2005 to nearly 6 percent in 2010, the study authors said.
Catheter-directed thrombolysis is an invasive treatment, and it's a potentially expensive one: $85,094 for the average hospital stay compared to $28,164 for patients given the anti-clotting medication and compression stockings, the researchers said.
Bashir's group found no significant difference in deaths between the treatments -- 1.2 percent for catheter-directed thrombolysis versus 0.9 percent for blood-thinning drugs.
But more complications were seen among patients who had catheter-directed thrombolysis. These included the need for blood transfusions, clots traveling to the lungs and bleeding in the brain. There was also a greater need for so-called vena cava filter placement -- placement of a filter to trap blood clots in the large vein that brings blood to the heart.
Patients who underwent catheter-directed thrombolysis also stayed in the hospital longer than those treated with anti-clotting drugs -- 7.2 days versus 5 days, according to the study.
Doctors should offer both treatment options to patients and explain the increased bleeding risks associated with catheter-directed thrombolysis on the one hand, and the increased risk of post-thrombotic syndrome with conventional treatment, on the other, he said.
"We believe this study data should foster shared decision making among the patients and their treating physician, which is very rarely done at present," Bashir said.
Fonarow said that a "randomized trial" that pits catheter-delivered thrombolysis against standard treatment is needed to see if catheter-delivered thrombolysis is better or not.
"While awaiting further evidence, catheter-delivered thrombolysis may be considered in patients with DVT who are at low risk for bleeding," Fonarow said.
To learn more about deep vein thrombosis, visit the U.S. National Heart, Lung, and Blood Institute.
Posted: July 2014