Architecture-based interpretation of contemporary dedicated venous stent outcomes: An IDE trial evidence synthesis
Karthigesu Aimanan, Muhammad Aizat Tamlikha Ismail, Pradeep Chand Chandran, Hanif HusseinObjective
Contemporary dedicated venous stent systems differ substantially in structural architecture and inferred mechanical behavior, yet whether this architectural variation translates into differences in clinical outcome remains incompletely understood, because available evidence is derived predominantly from heterogeneous single-arm Investigational Device Exemption (IDE) studies. This study aimed to compare twelve-month outcomes of contemporary dedicated venous stent systems across differing structural architectures, and to determine whether disease phenotype and lesion complexity, rather than architecture alone, account for the observed differences in outcome.
Methods
A structured review of prospective multicentre IDE and pivotal studies evaluating dedicated venous stents for symptomatic iliofemoral venous outflow obstruction was performed. Stent systems were classified according to architectural design into flexible laser-cut nitinol platforms, closed-cell constructs, and hybrid systems. Lesion complexity was operationalised as lesion length, occlusive burden, and common femoral vein involvement. Comparative interpretation focused primarily on harmonized twelve month outcomes stratified according to non-thrombotic iliac vein lesions, post-thrombotic disease, and acute deep vein thrombosis. Formal pooled meta-analysis and inter device superiority testing were not performed because of substantial heterogeneity between studies.
Results
Five prospective multicentre IDE or pivotal venous stent studies comprising 945 patients were included. Flexible laser cut nitinol platforms included the Abre, Venovo, and Zilver Vena systems, whereas the Vici platform represented a closed cell architecture and the Duo system represented a hybrid design. Across all studies, twelve month primary patency was consistently higher in non-thrombotic lesions than post-thrombotic disease irrespective of architecture, ranging from 95.2% to 100% and 70.4% to 83.1% respectively. Post-thrombotic cohorts consistently demonstrated greater lesion complexity, including higher occlusive burden and more frequent common femoral vein involvement.
Conclusion
Current IDE trial evidence suggests that disease phenotype and lesion complexity exert greater influence on venous stent outcomes than architecture alone. Although contemporary venous stent systems embody differing architecture related mechanical characteristics, including compression resistance, which was not directly assessed in this analysis, definitive superiority of any individual architectural category has not been established within currently available evidence.