Stenting is safe and effective and superior to balloon angioplasty for treatment of venous stenosis in patients with deep vein thrombosis (DVT), according to results from EVISTA-DVT, presented today as a Late-Breaking Clinical Trial at the Society for Cardiovascular Angiography and Interventions (SCAI) 2011 Scientific Sessions in Baltimore.
EVISTA-DVT focused on patients with blocked veins who had received clot-buster drug therapy (thrombolysis). Researchers found stenting was more effective than balloons alone at restoring and maintaining blood flow through the thigh veins.
"We are encouraged by these study results," said Mohsen Sharifi, MD, FSCAI, director of Arizona Cardiovascular Consultants and adjunct professor at A.T. Still University in Mesa, Ariz. "For patients with DVT, stenting is a viable option, as demonstrated by the success rates for patients studied in this trial."
DVT affects approximately 350,000 to 600,000 Americans each year. Blood clots form in a vein in the lower leg and thigh. If left untreated, the clot can block blood flow through the vein. If the clot moves through the bloodstream, it can get stuck in the lungs leading to pulmonary embolism and possibly death. It is estimated at least 100,000 deaths may be directly or indirectly related to DVT and blood clots that travel to the lungs. Inserting a stent – a tiny mesh tube – opens up the blockage that may cause future clot formation.
The trial included 141 patients who had initial clot-dissolving drug therapy, but continued to have blockage of their vein. Patients were randomly assigned to further treatment with stenting (71 patients) or balloon venoplasty alone (70 patients) to open up the blocked vein. Every six months researchers checked blood flow through the leg veins using ultrasound.
During a follow-up that averaged 35 months, three patients (4%) in the stent group and seven patients (10%) in the balloon venoplasty group redeveloped DVT. The patency – or openness – of the treated vein was higher in the stent group versus the control group.
"Although stenting is common in the coronary and peripheral arteries, it is still relatively uncommon – and its outcome fundamentally different – in the venous segments below the groin, such as those found in the thigh veins," said Dr. Sharifi. "Over the last decade, we have seen improved patient outcomes with percutaneous endovenous intervention( PEVI) for the treatment of DVT."