Stenting Eases Hard-to-Treat Venous Disease After Deep Vein Thrombosis

Stenting and enhanced antithrombotic therapy together reduced the severity of post-thrombotic syndrome in the phase III C-TRACT trial — albeit with patients left at higher bleeding risk.

There was a significant improvement in disease severity and quality of life in patients who were randomized to the intervention as opposed to usual care for their moderate or severe post-thrombotic syndrome and imaging-confirmed iliac-vein obstruction, reported Suresh Vedantham, MD, of Washington University School of Medicine in St. Louis, and colleagues.

At 6 months, there were observable between-group differences in terms of:

• Post-thrombotic syndrome severity scored: mean scores 8.1 vs 10 points on the Venous Clinical Severity Score tool with a range of 0-30 (P=0.001)
• Venous disease-specific quality of life: 62.8 vs 48.6 points on a scale of 0-100 on the Venous Insufficiency Epidemiological and Economic Study Quality of Life questionnaire (P<0.001)
• Overall quality of life: 56 vs 49.9 points on a scale of 0-100 on the Medical Outcomes Study 36-Item Short-Form Health Status Survey physical component summary score (P<0.001)

Overall, the trial confirms prior signals of endovascular therapy’s effectiveness, now with a larger study focused on post-thrombotic syndrome as opposed to mixed venous disease. The downside: an increase in bleeding in the endovascular therapy group (11.% vs 3.6%, P=0.03), according to the 225-person C-TRACT report in the New England Journal of Medicine. The study was presented at the Society of Interventional Radiology annual meeting in Toronto.

“For patients with severe, refractory post-thrombotic syndrome and a risk of hemorrhage that is deemed to be acceptable, this trial offers a credible basis for incorporating endovascular therapy into individualized care,” commented Ronald Luiz Gomes Flumignan, MD, PhD, and Luis Carlos Uta Nakano, MD, PhD, both of Universidade Federal de São Paulo, in an accompanying editorial.

Post-thrombotic syndrome is a common complication after deep vein thrombosis (DVT). Veins that remain damaged, despite treatment of the blood clot, can result in symptoms like pain, itching, and swelling. By eliminating chronic venous obstruction, endovascular therapy was hypothesized to help relieve the severity and symptoms of post-thrombotic syndrome in C-TRACT.

“These findings highlight the value of iliac-vein outflow after DVT, which is in alignment with the open-vein hypothesis,” Vedantham’s group wrote. “Although most of the episodes of bleeding were nonmajor and occurred months after endovascular therapy, an increased risk of bleeding associated with enhanced antithrombotic therapy is a clinical trade-off of adopting a stent placement strategy.”

Notably, the intervention group had also received enhanced antithrombotic therapy, making it “impossible to disentangle the independent contributions of each component,” according to Gomes Flumignan and Uta Nakano.

They stressed that the optimal antithrombotic regimen after stenting remains unanswered, as is the question of the durability of stenting.

“Metallic venous stents are permanent implants, yet the C-TRACT trial captures outcomes for only the first 6 months … 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. Cost-effectiveness analyses remain outstanding,” Gomes Flumignan and Uta Nakano wrote.

“Pending those data, the C-TRACT trial provides the strongest available evidence that endovascular therapy leads to a reduction in the severity of post-thrombotic syndrome and improvement in quality of life in carefully selected patients with moderate or severe disease and confirmed iliac obstruction. Shared decision-making should integrate patient preferences, individual bleeding risk, access to experienced operators, and the realistic magnitude of expected benefit,” they stated.

The phase III trial was conducted in 29 centers in the U.S. From 2018 to 2025, investigators enrolled patients with moderate or severe post-thrombotic syndrome — the individual having substantial limitations in daily activities or work capacity owing to venous symptoms in the ipsilateral leg following an instance of DVT at least 3 months prior — and iliac-vein obstruction on imaging.

Participants were randomized to one of two groups: the intervention group receiving iliac vein stent placement and enhanced antithrombotic therapy with usual care, or those getting usual care alone (e.g., compression stockings, anticoagulant therapy, lifestyle guidance, and referral to wound care clinics).

The endovascular procedure was performed with the treating physician’s choice of access vein, method of crossing the obstructed veins, and the type of commercially available stent. Catheter venography and intravascular ultrasounds were required before veins were predilated and stents deployed. After endovascular therapy, the use of therapeutic anticoagulants and aspirin (81 mg daily) was recommended for at least 6 months if the patient had no contraindications to either.

There were 225 patients randomized, approximately 47% of whom were women with an average age of 55. Also, 24% were Black and 12% Hispanic or Latino.

The proportion of iliac veins deemed patent (flow present with <50% stenosis) at 6 months was 62.5% versus 36.6% between the endovascular therapy and control groups, respectively, though vein status was unknown for another 17% and 39.3%.

Procedure-related serious adverse events included stent deformation in one patient (corrected during the procedure with balloon angioplasty) and groin pain resulting in hospitalization in one patient.

Major bleeding occurred in four patients in the intervention group and one in the control group. No episodes of bleeding were fatal or led to open surgical therapy.

Of note, the C-TRACT trial had undergone a sample size reduction because an interim analysis had found the numbers of crossovers and losses to follow-up to be lower than expected.