Among patients with challenging venous lesions, a venous stent was associated with high rates of primary patency and freedom from major adverse events at 24 months, according to new data from the VIRTUS trial.
As Healio previously reported, the venous stent (Vici, Boston Scientific/Veniti) exceeded performance goals for primary patency at 12 months and freedom from major adverse events at 30 days. Robert Lookstein, MD, MHCDL, FSIR, FAHA, FSVM, professor of radiology and surgery and the vice chairman of diagnostic, molecular and interventional radiology in the Mount Sinai Health System, presented the 24-month results at the International Symposium on Endovascular Therapy.
At 24 months, of the 170 patients in the study, 79.4% maintained primary patency according to duplex ultrasound, Lookstein said during a presentation, noting the rate was high in those with nonthrombotic lesions than in those with post-thrombotic lesions (96.4% vs. 73.4%).
He said the rate of freedom from target vessel revascularization was 88.7% at 24 months.
The rates of death (0.7%), deep vein thrombosis (0.7%), suspected or confirmed pulmonary embolism (0.7%) and stent movement (0%) were low at 24 months, Lookstein said.
The patients (mean age, 54 years; 44% men) had clinically significant chronic nonmalignant obstruction of the common femoral vein, the external iliac vein, the common iliac vein or any combination of them, according to the researchers. Mean percent stenosis was 77.5%, 31.2% of patients had total occlusion and 31.8% had stenosis in all three segments.
“The major takeaway message from the VIRTUS trial is that, in distinction to other trials that have been presented or are being prepared for presentation, the VIRTUS trial studied an extremely complex and symptomatic cohort of patients suffering from the post-thrombotic syndrome,” Lookstein told Healio. “Despite the fact that such a complex and challenging cohort was studied, the results are excellent, as demonstrated by the incredible 24-month patency data, which were further improved upon when the nonthrombotic cohort was reviewed in a subset analysis.”
The stent was approved by the FDA in May, as Healio previously reported.
“The 24-month data demonstrate that the Vici stent is highly effective in the most complex lesion subsets in the most complex patients, with an excellent safety profile,” Lookstein said in an interview. – by Erik Swain
Lookstein R, et al. Venous Interventions: Chronic and Acute Venous Occlusions. Presented at: the International Symposium on Endovascular Therapy (ISET); Jan. 22-25, 2020; Hollywood, Fla.
Disclosures: The study was funded by Veniti, now part of Boston Scientific. Lookstein reports he consults for Boston Scientific and Medtronic, serves on the speakers bureau for Abbott, Endologix and Medtronic, received research support from AngioDynamics, Bard, Boston Scientific, Penumbra, Philips Healthcare and Veniti and serves on clinical events committees for Intact Vascular, QT Vascular and Shockwave Medical.