The addition of stenting to usual care reduced symptoms and improved quality of life for patients with the condition after DVT.

Patients who develop postthrombotic syndrome and obstructed iliac veins following deep vein thrombosis (DVT) experience more symptom relief when endovascular therapy is added to usual care, according to results from the C-TRACT trial.

At 6 months, patients randomized to iliac vein stenting and enhanced antithrombotic therapy had better scores on the Venous Clinical Severity Score (VCSS), an assessment of the severity of postthrombotic syndrome, than those treated with standard care consisting of compression stockings, anticoagulant therapy, lifestyle modification, and referral for wound care.

“In addition, both when we were looking at venous symptoms and health, and looking at patient’s overall health status, the patients who were stented [had] improved health-related quality of life demonstrated by higher scores on questionnaires. The size of the differences are pretty robust relative to what we know about the scales,” said lead investigator Suresh Vedantham, MD (Washington University School of Medicine, St. Louis, MO), speaking with the media following his presentation at the Society of Interventional Radiology 2026 annual scientific meeting.

He noted that about 40% of patients who develop a DVT in or above the knee will develop postthrombotic syndrome as a complication. This happens as a result of treated clots that haven’t fully dissolved and become sticky or develop into scar tissue that clogs up veins and prevents smooth blood flow. Typically, patients with the syndrome experience leg swelling, aching, heaviness, and ulcerations, he added.

Operators in the trial were allowed to use any commercially available venous stent, with those most commonly used being Abre (Medtronic) and Venovo (Becton Dickinson). The C-TRACT investigators did not explicitly study outcome differences between the different stents.

“I do think that this is more of a class effect,” Vedantham told TCTMD, adding that the studies that were done to get US Food and Drug Administration approval of all available venous stents were fairly similar, with no reason to suspect there will be disparities based on the device. “If I had to guess, I’d anticipate that we’ll find pretty similar results across the stents that have been approved,” he said.

The study was simultaneously published in the New England Journal of Medicine.

C-TRACT Results

Vedantham and colleagues randomized 225 patients (mean age 55 years; 47% women) with moderate or severe postthrombotic syndrome and obstructed iliac veins at 29 sites in the United States. Those in the endovascular group underwent iliac vein stenting at a median of 16 days after randomization, with 100% having complete or partial vein obstruction on imaging. Endovascular patients received anticoagulation during the procedure, and their physicians were advised to prescribe therapeutic anticoagulants and daily aspirin for at least 6 months following the procedure for those with no contraindications.

At 6 months, VCSS scores were lower by 2 points in the endovascular group compared with the usual-care group (P = 0.001). The results were consistent in sensitivity analyses and across prespecified subgroups.

If I had to guess, I’d anticipate that we’ll find pretty similar results across the stents that have been approved. Suresh Vedantham

After adjustment, quality of life as measured by the Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) questionnaire was 14.5 points higher in the endovascular group compared with the usual-care group (P < 0.001). The mean 36-Item Short-Form Health Status Survey (SF-36) for overall quality of life showed greater improvement by 6.1 points in the endovascular group versus usual care (P < 0.001).

Rates of major and nonmajor bleeding were higher with stenting at 11.6% versus 3.6% with usual care (P = 0.03), driven by more nonmajor bleeding events (9.8% vs 2.7%). No episodes of bleeding were fatal or led to open surgery.

There were no differences between treatment groups in the incidence of symptomatic recurrent venous thromboembolism or death.

Personalized Care Discussions Needed

Sahil Parikh, MD (NewYork-Presbyterian/Columbia University Irving Medical Center, New York, NY), who was not involved in the C-TRACT trial, said the results validate what many endovascular specialists have believed for a long time despite scant evidence.

“Postthrombotic syndrome is a complicated condition, but it’s actually very common,” he told TCTMD. “For the purposes of what the patient is experiencing, they do feel better when they get stented, however, that comes clinically at the expense of more bleeding, so you have to weigh the risk and the benefit.”

The researchers acknowledge that a higher risk of bleeding is a trade-off of endovascular therapy, noting that most episodes occurred months after undergoing the procedure and were the result of the risk associated with enhanced antithrombotic therapy.

To TCTMD, Vedantham said one takeaway of the trial is the need to actively study bleeding algorithms in this population.

“Patients all come in with slightly different risks of clotting and different risks of bleeding, and so it’s important to individualize our care,” he said. “It’s exciting that there are new classes of blood-thinning drugs that are being studied now in clinical trials that may better balance bleeding and clotting. So, we’re hopeful that as those drugs eventually enter the marketplace, that the ability for this form of treatment to do even better by being able to keep the stents open and also minimize the risk of bleeding is going to continually improve.”

Since patients in the endovascular arm received both iliac stenting and intensified antithrombotic therapy, it’s difficult to untangle the independent contributions of each component to the improved outcomes, say Ronald Luiz Gomes Flumignan, MD, PhD, and Luís Carlos Uta Nakano, MD, PhD (both Universidade Federal de São Paulo, Brazil), in an editorial accompanying the study.

One of the biggest unanswered questions, they add, is the durability of stenting beyond 6 months of follow-up.

“Data at 12 to 24 months that would link patency trajectories to symptom outcomes are needed before stenting can be incorporated into routine guideline recommendations,” they write, adding that cost-effectiveness analyses also are needed.

Vedantham and colleagues say longer follow-up will allow them to “elucidate relationships between anatomical and clinical outcomes, and further explore the use of endovascular therapy in patients with venous ulcers.”

The editorialists say the study highlights the need for shared decision-making, which “should integrate patient preferences, individual bleeding risk, access to experienced operators, and the realistic magnitude of expected benefit.”

Likewise, Parikh said the C-TRACT data are welcome because they clarify the patient population and the physiology most likely to benefit from iliac-vein stenting. He agreed that individual decision-making is paramount, particularly because so many real-world patients with postthrombotic syndrome are fairly young, including women of childbearing age for whom a pelvic stent may be an unwanted complication.

“In those cases we have a sanguine discussion about pregnancy and family planning,” he said. “We think that these stents will last a long time, but there is a pretty decent recurrence rate that should be acknowledged, so these patients need to know that they have to stay on their meds and they need to come in for surveillance.”