A procedure to reopen blocked veins successfully reduces pain, swelling and disability in people with post-thrombotic syndrome — a common and often debilitating complication of deep vein thrombosis — according to results of a clinical trial published in The New England Journal of Medicine.
Post-thrombotic syndrome develops in as many as half of patients after a deep vein thrombosis, which occurs when damage from a blood clot leaves the veins narrowed/blocked and inflamed. The condition can cause chronic leg pain, swelling, skin changes and ulcers that limit mobility and quality of life, said Kush Desai, ‘07 MD, ’12 GME, chief of Vascular and Interventional Radiology in the Department of Radiology, who was a co-author of the current clinical trial.
“These patients suffer in silence,” Desai said. “It’s underdiagnosed, or frankly, not diagnosed, and we have had no proven way to treat it.”
The new study tested whether endovascular therapy — placing a metal stent in the vein to restore blood flow, combined with enhanced antithrombotic treatment — could improve outcomes for patients with moderate to severe post‑thrombotic syndrome and confirmed venous obstruction.
Investigators randomly assigned 225 patients to receive either endovascular therapy plus standard care or standard care alone, which includes compression therapy, medications and lifestyle changes. Symptom severity at six months was assessed using the Venous Clinical Severity Score.
At six months, patients who received endovascular therapy had significantly less severe symptoms than those who received standard care alone, according to the findings, and patients treated with stents also reported better quality of life and better overall physical health
At the same time, the therapy was also associated with more complications. Through six months of follow‑up, bleeding events occurred in nearly 12 percent of patients who underwent endovascular treatment, compared with about 4 percent of those who received standard care alone.
Desai noted that patients that receive endovascular therapy need blood thinners, whereas those that receive standard care frequently do not.
“This may be an explanation as to why bleeding occurred more frequently in those patients, and points to the need for providers to be aware of those risks,” Desai said.
“The standard of care for so long has been compression socks, blood thinners and medications that treat the symptoms, but don’t really strike at the cause,” Desai said. “The idea was: Does opening up that blockage with a stent give these patients an improvement not only in their symptoms, but their quality of life — and does it do so safely?”
While the treatment is not appropriate for all patients with post‑thrombotic syndrome, it may offer an option for carefully selected individuals with significant large vein obstruction and persistent symptoms, Desai said.
Beyond supporting a new treatment strategy, Desai said the study may improve recognition of a condition that frequently goes undiagnosed.
“If you don’t recognize the disease, you don’t know which specialist to refer that patient to,” Desai said. “Now physicians can recognize it, put a name to it and know there are specialists who focus on post‑thrombotic syndrome care.”
Moving forward, Desai and his collaborators will continue to analyze the trial data to better understand which patients benefit most from endovascular therapy. Longer‑term follow‑up will also examine whether the symptom relief persists and how stents perform over time, he said.
“We’ve always thought these patients had hope,” Desai said. “But now we can say they do have hope. We actually have an approach that we’ve proven works.”
The study was funded by the National Heart, Lung, and Blood Institute.
