Twelve-month primary results from the Gore Viabahn Fortegra prospective, multicentre trial evaluating a novel venous stent system suggest endovascular treatment of symptomatic iliocaval obstruction with the stent system was “effective”, showing high patency rates and improved quality of life reports.
Presented at the Society of Interventional Radiology (SIR) annual meeting (11–15 April, Toronto, Canada) by Robert Lookstein (Icahn School of Medicine at Mount Sinai, New York, USA) on behalf of the global principal investigators, including Kush Desai (Northwestern University, Evanstone, USA), Steven Abramowitz (MedStar Health, Maryland, USA), Erin Murphy (Sanger Heart & Vascular Institute, Charlotte, USA), and Stephen Black (Guy’s and Saint Thomas Hospital, London, UK). The study assessed the Gore Viabahn Fortegra venous stent for the treatment of symptomatic inferior vena cava (IVC) obstruction with or without combined iliofemoral obstruction.
The trial formed part of a broader clinical programme initiated under the US Food and Drug Administration’s Breakthrough Devices programme. Two parallel studies were subsequently commissioned to evaluate the technology in the IVC and iliofemoral venous systems, with the current analysis focusing on the IVC cohort.
Conducted across sites in the USA, Australia, New Zealand and Europe, the study enrolled 104 patients, of whom 99 underwent an index procedure. Of these patients, 89 received the investigational device. Follow-up data were available for 86 patients at 12 months. The primary endpoint was defined as s a composite measure of primary patency and freedom from stent embolization at 12 months, 30-day freedom from pulmonary embolism (PE), device- or procedure-related death, major bleeding, and vascular injury requiring surgical or endovascular intervention.
“This was undoubtedly a chronically symptomatic cohort,” noted the speaker, with 78% experiencing symptoms for more than three months prior to intervention. Patients had a median age of 51 and 38% were female. Disease severity was defined by a clinical, aetiological, anatomical and pathophysiological (CEAP) classification of C3 or greater, or a venous clinical severity score (VCSS) of at least two. Notably, 20% of patients had IVC atresia, while 40% had a pre-existing IVC filter.
The mean duration of procedures was just over three hours and lesions frequently involved multiple venous segments—94% of patients had disease spanning the IVC and bilateral iliofemoral veins. The most common stenting configuration was a confluent, or “upside-down Y” arrangement, Lookstein described, which was offered in over 96% of cases. Devices were placed across the inguinal ligament in approximately two-thirds of patients.
The study met its primary performance goal, with freedom from a primary endpoint event achieved in 74.7% of patients, exceeding the prespecified performance threshold of 58%. Kaplan-Meier estimates of primary and secondary patency, and freedom from clinically driven target revascularisation at 12 months were 83.4, 95.1 and 89.7%, respectively.
The presented noted that there were no PEs, no device- or procedure-related vascular injuries requiring intervention, four procedure-related major vascular bleeding events, and one procedure-related death through 30 days. There was no stent embolization through 12 months. At 12 months, Kaplan–Meier estimates demonstrated primary patency of 84.3% and secondary patency of 95.1%.
Additionally, significant improvements in clinical symptoms were observed over the follow-up period. Mean VCSS pain scores decreased by 1.4 points at 12 months, a “highly statistically significant” result, Lookstein reported. Further, no worsening of pain was noted among patients who had a baseline VCSS pain score of zero. Additional components of the VCSS also improved, including reductions in ulcer burden, venous oedema and induration.
