Improved Outcomes and Cost Savings With the New-Generation Balloon-Expandable Covered Stent in Aortoiliac Occlusive Disease: Preliminary Results Overview From an Italian Perspective
Author(s)
Lorenzo Pradelli, MD1, Michele Antonello, Professor2, Gianmarco De Donato, Professor3, Stefano Fazzini, Professor4, Elda C. Colacchio, PhD2, Edoardo Pasqui, PhD3, Cecilia Molino, PhD3, Geraldo Tadinho Monteverde Spencer, MSc5, Alberto Ateca, MSc6, Luca Castello, MSc7, Kashfa Iqbal, PharmD8.
1Director, Adres HE&OR, Torino, Italy, 2University of Padua, Padua, Italy, 3University of Siena, Siena, Italy, 4Università degli Studi di Roma Tor Vergata, Rome, Italy, 5W.L. Gore & Associates, Monteriggioni, Italy, 6WL GORE & Associates, Madrid, Spain, 7Adres HE&OR, Turin, Italy, 8W.L. Gore & Associates, Livingstone, United Kingdom.
1Director, Adres HE&OR, Torino, Italy, 2University of Padua, Padua, Italy, 3University of Siena, Siena, Italy, 4Università degli Studi di Roma Tor Vergata, Rome, Italy, 5W.L. Gore & Associates, Monteriggioni, Italy, 6WL GORE & Associates, Madrid, Spain, 7Adres HE&OR, Turin, Italy, 8W.L. Gore & Associates, Livingstone, United Kingdom.
OBJECTIVES: Aorto-iliac occlusive disease (AIOD) is a severe vascular condition requiring effective revascularization strategies to restore blood flow and prevent complications. This analysis evaluates the economic impact of a new generation balloon expandable covered stent for treating AIOD in the Italian healthcare setting compared to alternative covered stents.
METHODS: A cost-analysis model was used to simulate AIOD patient outcomes from the pre-operative phase through intra-procedural and post-operative events. The model compared the new generation balloon expandable covered stent with the weighted average of alternative covered stents available in Italy. Clinical inputs were obtained from pooled studies identified by a systematic literature review, and cost parameters were derived from literature sources, diagnosis-related group tariffs and public tender data. The model considered direct healthcare costs, including device acquisition and expenditure related to the management of complications. Uncertainty was assessed by means of deterministic and probabilistic sensitivity analyses (DSA and PSA).
RESULTS: The total mean cost per patient over a 3-year time horizon was estimated at €4,173 for the new generation balloon expandable covered stent compared to €4,634 for the alternative stents, resulting in average cost savings of €461 per patient. Despite higher initial device costs, the reduction in complication-related expenses completely offset this difference. Results were stable when testing the main sources of uncertainty: in DSA, none of the extreme input values changed the overall conclusion of the analysis; the PSA indicated cost savings in 92% of simulations.
CONCLUSIONS: This new generation balloon expandable covered stent shows better clinical outcomes in this analysis, including lower rates of myocardial infarction, major amputation and target lesion revascularization over 36 months. It may be a cost-effective alternative for AIOD treatment in Italy, offering better clinical outcomes, lower overall treatment costs and reducing healthcare expenditure compared to current market alternatives.
METHODS: A cost-analysis model was used to simulate AIOD patient outcomes from the pre-operative phase through intra-procedural and post-operative events. The model compared the new generation balloon expandable covered stent with the weighted average of alternative covered stents available in Italy. Clinical inputs were obtained from pooled studies identified by a systematic literature review, and cost parameters were derived from literature sources, diagnosis-related group tariffs and public tender data. The model considered direct healthcare costs, including device acquisition and expenditure related to the management of complications. Uncertainty was assessed by means of deterministic and probabilistic sensitivity analyses (DSA and PSA).
RESULTS: The total mean cost per patient over a 3-year time horizon was estimated at €4,173 for the new generation balloon expandable covered stent compared to €4,634 for the alternative stents, resulting in average cost savings of €461 per patient. Despite higher initial device costs, the reduction in complication-related expenses completely offset this difference. Results were stable when testing the main sources of uncertainty: in DSA, none of the extreme input values changed the overall conclusion of the analysis; the PSA indicated cost savings in 92% of simulations.
CONCLUSIONS: This new generation balloon expandable covered stent shows better clinical outcomes in this analysis, including lower rates of myocardial infarction, major amputation and target lesion revascularization over 36 months. It may be a cost-effective alternative for AIOD treatment in Italy, offering better clinical outcomes, lower overall treatment costs and reducing healthcare expenditure compared to current market alternatives.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EE546
Topic
Clinical Outcomes, Economic Evaluation, Medical Technologies
Disease
Cardiovascular Disorders (including MI, Stroke, Circulatory), Surgery