A U.S. Cost-Consequence Analysis Of The Covered Balloon-Expandable Stents For Management Of Aortoiliac Occlusive Disease
Patricia Lu, MD1, William Sheaffer, MD1, Victor Davila, MD1, Ina Soh, MD1, William Stone, MD1, Paula Davis2, Frank O'Neill2, Andrew Meltzer, MD, MBA1.
1Mayo Clinic, Phoenix, AZ, USA, 2W. L. Gore & Associates, Flagstaff, AZ, USA.
OBJECTIVE: Covered balloon expandable stents (CBES) have been proven safe and effective in the treatment of aorto-iliac occlusive disease (AIOD). Several studies suggest CBES may be clinically superior to bare-metal stents, resulting in increased use of CBES for AIOD. The Gore Viabahn VBX balloon-expandable endoprosthesis (VBX Device) is indicated for the treatment of de novo or restenotic lesions found in iliac arteries (5 mm - 13 mm lesions up to 110 mm, including at the aortic bifurcation). Despite proven clinical efficacy, there is lack of comparative clinical and economic data between VBX Device and alternative CBES to inform decision-making and device selection. The purpose of this study is to compare costs associated with VBX Device compared to alternate CBES for the management of AIOD.
METHODS: A cost-consequence model was developed to simulate the pre-operative, intraoperative, and post-operative (up to 3 years) management of patients with AIOD. Clinical parameters and outcomes were modeled based on published data in the VBX Device and alternative CBES pivotal trials, in addition to CMS cost data. RESULTS: Despite higher device costs, VBX Device use was associated with an overall reduction in costs of $3,534 per patient at 3 years, compared to alternative CBES. Cost-savings were largely driven by a reduction in adverse events and re-interventions ($2,879). VBX Device use is associated with lower target lesion revascularization rate (8.6%) vs alternative CBES (14.7%). Lower rates of acute limb ischemia, rupture, amputation, and cardiac complications also contributed to VBX Device cost-effectiveness.CONCLUSIONS: Using the ‘best-available’ clinical evidence and established economic modelling, VBX Device has cost-savings at 3 years, compared to alternative CBES. Superior cost-effectiveness with VBX Device is driven by reduced reinterventions and lower complication rates. This study underscores the importance of a holistic approach to CBES cost-effectiveness assessment, which is primarily driven by differences in clinical outcome throughout follow-up.
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