Endovascular Therapy with Iliac Vein Stenting Benefits Patients with Post-Thrombotic Syndrome: NEJM
USA: In the phase III C-TRACT trial, endovascular therapy using iliac vein stenting combined with enhanced antithrombotic therapy in patients with moderate-to-severe post-thrombotic syndrome and iliac vein obstruction resulted in significant improvement in disease severity and health-related quality of life at 6 months compared to usual care. However, this benefit was accompanied by an increased overall risk of bleeding, although major bleeding events remained uncommon, indicating a favorable but cautious risk–benefit profile for clinical practice.
Post-thrombotic syndrome (PTS) is a frequent and often debilitating long-term complication of deep-vein thrombosis, characterized by chronic limb pain, swelling, and functional limitation that significantly impair daily activities and overall well-being. Persistent venous obstruction, particularly in the iliac veins, plays a key role in the pathophysiology of PTS. Endovascular approaches, including stent placement to restore venous outflow, have been proposed as a strategy to alleviate these symptoms, but robust randomized evidence has been limited until now.
To address this gap, Suresh Vedantham and colleagues conducted the phase III C-TRACT trial, published in the New England Journal of Medicine. The study included 225 patients with imaging-confirmed iliac vein obstruction and moderate-to-severe PTS, randomly assigned to endovascular therapy (iliac vein stenting plus intensified antithrombotic therapy) with standard care or standard care alone. The primary outcome was PTS severity at 6 months, measured using the Venous Clinical Severity Score (VCSS; 0–30 scale), with blinded outcome assessment.
Key Findings:
- At 6 months, endovascular therapy significantly reduced post-thrombotic syndrome (PTS) severity compared to standard care alone.
- Mean Venous Clinical Severity Score (VCSS) was 8.1 in the intervention group vs 10.0 in the control group.
- Adjusted mean difference in VCSS was −2.0 points, indicating a statistically significant improvement.
- Findings suggest that iliac vein stenting and relief of venous obstruction lead to clinically meaningful symptom reduction.
- Patients receiving endovascular therapy showed significantly better venous disease–specific quality of life.
- VEINES-QOL scores improved by an adjusted difference of 14.5 points in the intervention group
- Overall physical health status also improved, with SF-36 physical component scores increasing by 6.1 points.
- Results indicate a positive impact on functional status and daily living.
- Bleeding events were more frequent in the endovascular therapy group over 6 months.
- Bleeding occurred in 11.6% of patients in the intervention group vs 3.6% in the standard care group.
- The increase in bleeding risk was statistically significant.
- Major bleeding events were rare, suggesting risks may be manageable with careful patient selection and monitoring.
Overall, the C-TRACT trial provides important evidence supporting the use of endovascular therapy in selected patients with moderate-to-severe PTS and iliac vein obstruction. The findings highlight a clear improvement in symptom burden and quality of life, balanced against a higher, yet generally manageable, risk of bleeding.
Reference:
DOI: 10.1056/NEJMoa2519001
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