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VIRTUS: Venous stent safe, effective at 12 months
A venous stent was associated with high rates of primary patency and low rates of adverse events at 12 months, according to data presented at Leipzig Interventional Course.
Researchers conducted the VIRTUS pivotal study of the venous stent (Vici, Boston Scientific/Veniti) in 170 patients (mean age, 54 years; 44% men) with obstruction of the iliofemoral venous outflow tract.
“Studies show that approximately 20% to 25% of patients with superficial venous reflux disease also have a component of venous outflow obstruction. Similarly, 50% to 60% of patients who are treated for iliofemoral [deep vein thrombosis] by catheter-based interventions are found to have obstructive lesions in their central veins,” presenter Mahmood K. Razavi, MD, FSIR, FSVM, director of the department of clinical trials at the Heart & Vascular Center of St. Joseph Hospital in Orange, California, told Cardiology Today’s Intervention. “All of these patients may benefit from iliofemoral venous stent placement. In addition, there is a segment of the population without any history of [venous thromboembolism] who have symptomatic iliac vein compression. The latter group could also benefit from relief of their venous obstruction by stent placement.”
The primary efficacy endpoint was primary patency at 12 months, defined as freedom from thrombosis-related occlusion, reintervention on the target vessel and in-stent restenosis of more than 50%. The primary safety endpoint was 30-day major adverse events, defined as device- or procedure-related death, device- or procedure-related bleeding, device- or procedure-related arterial or venous injury, device- or procedure-related acute DVT outside the target vein segment, clinically significant pulmonary embolism or stent embolization.
All patients underwent venography and IVUS before stenting and venography, IVUS and duplex ultrasound after stenting and at 12 months. Mean lesion length was 111.3 mm and 31.2% of patients had a total occlusion.
At 12 months, primary patency was 84%, exceeding the performance goal of 72.1% (P < .0001), Razavi said during his presentation.
The rate of freedom from major adverse events at 30 days was 95.8%, exceeding the performance goal of 94%, he said.
Venous Clinical Severity Score among the cohort declined from 10 at baseline to 5.6 at 12 months, and the proportion with a score of 8 or more declined from 65.8% at baseline to 27.3% at 12 months, according to the researchers.
“VIRTUS enrolled a challenging group of symptomatic patients with iliofemoral venous disease who were successfully treated using the Vici stent designed specifically for venous disease. The study showed excellent efficacy and safety of the stent, both superior to the objective performance goals set by the FDA,” Razavi said in an interview. “Availability of a stent system designed specifically for venous disease allows physicians to use optimal tools to treat their patients with such symptomatic disease. Such has not been available in the past. The results of the study confirm the safety and efficacy of the Vici stent system.”
The device is not yet approved for commercial use in the United States, but received a CE mark for commercial use in Europe in 2013. – by Erik Swain
Reference:
Razavi MK, et al. Venous stent placement for post-thrombotic syndrome. Presented at: Leipzig Interventional Course; Jan. 22-25, 2019; Leipzig, Germany.
Disclosure: The study was funded by Veniti, now part of Boston Scientific. Razavi reports he consults for Boston Scientific/Veniti.