Clinical and economic implications of focal dissection treatment following percutaneous transluminal angioplasty of the superficial femoral artery: an exploratory analysis based on the TOBA II Study

Aim: Percutaneous transluminal angioplasty (PTA) for peripheral artery disease (PAD) commonly leads to dissections which are associated with higher target lesion revascularization (TLR) rates. Clinical and economic consequences of dissection management in the femoropopliteal artery following PTA,...

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Main Authors: Jan B Pietzsch, Benjamin P Geisler, Abigail M Garner, Anne M Ryschon, William A Gray, Masahiko Fujihara, Peter A Schneider
Format: Article
Language:English
Published: Becaris Publishing Limited 2024-12-01
Series:Journal of Comparative Effectiveness Research
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author Jan B Pietzsch
Benjamin P Geisler
Abigail M Garner
Anne M Ryschon
William A Gray
Masahiko Fujihara
Peter A Schneider
author_facet Jan B Pietzsch
Benjamin P Geisler
Abigail M Garner
Anne M Ryschon
William A Gray
Masahiko Fujihara
Peter A Schneider
author_sort Jan B Pietzsch
collection DOAJ
description Aim: Percutaneous transluminal angioplasty (PTA) for peripheral artery disease (PAD) commonly leads to dissections which are associated with higher target lesion revascularization (TLR) rates. Clinical and economic consequences of dissection management in the femoropopliteal artery following PTA, and specifically the potential economic benefit of focal dissection repair using the novel Tack Endovascular System, remain unknown. Methods: A decision-analytic model was used to estimate 24-month clinical events, costs and quality-adjusted life year (QALY) gain for a Tack-supported versus status-quo PTA strategy. Patient and lesion characteristics and TLR rates were derived from the PTA cohort of the TOBA II clinical trial, an observational cohort, and literature. Cost–effectiveness was determined from a US payer and provider perspective separately for the non-severe (grade A or B), severe (grade C and higher) and the entire dissection cohort. Results: TLR rates were lower for the Tack-supported strategy compared with PTA (7.7 vs 27.4% in the non-severe, 13.9 vs 25.8% in the severe and 12.0 vs 26.3% in the entire dissection cohort). Cost and QALY differences were +$297/ + 0.0110 in the non-severe dissection cohort and - $1602/ + 0.0067 in the severe dissection cohort, resulting in an incremental cost–effectiveness ratio (ICER) of $25,622 in the non-severe cohort and dominance in the severe cohort and the entire cohort. Conclusion: Compared with a ‘status-quo’ approach, proactive focal stenting may lead to fewer reinterventions and improved quality of life. There appears to be a graded economic benefit of focal dissection treatment, being cost-effective in non-severe dissections and even cost saving in severe dissections.
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spelling doaj-art-31cab84838b84a60bd17d433dd3b49c12024-12-16T09:23:23ZengBecaris Publishing LimitedJournal of Comparative Effectiveness Research2042-63132024-12-0114110.57264/cer-2024-0055Clinical and economic implications of focal dissection treatment following percutaneous transluminal angioplasty of the superficial femoral artery: an exploratory analysis based on the TOBA II StudyJan B Pietzsch0https://orcid.org/0000-0002-5078-1939Benjamin P Geisler1Abigail M Garner2Anne M Ryschon3William A Gray4Masahiko Fujihara5Peter A Schneider6Wing Tech Inc., Menlo Park, CA USAInstitute of Social Medicine, Epidemiology & Health Economics, Charite – Universita¨ tsmedizin Berlin, corporate member of Freie Universitat Berlin & Humboldt Universitat zu Berlin, Berlin, Germany; Department of Medicine, Massachusetts General Hospital/Harvard Medical School, Boston, MA USAWing Tech Inc., Menlo Park, CA USAWing Tech Inc., Menlo Park, CA USALankenau Heart Institute, Wynnewood, PA USADepartment of Cardiology, Kishiwada Tokushukai Hospital, Kishiwada, Japan; Department of Medicine & Biosystemic Science, Kyushu University Graduate School of Medical Sciences, Fukuoka, JapanDivision of Vascular & Endovascular Surgery, University of California San Francisco, San Francisco, CA USAAim: Percutaneous transluminal angioplasty (PTA) for peripheral artery disease (PAD) commonly leads to dissections which are associated with higher target lesion revascularization (TLR) rates. Clinical and economic consequences of dissection management in the femoropopliteal artery following PTA, and specifically the potential economic benefit of focal dissection repair using the novel Tack Endovascular System, remain unknown. Methods: A decision-analytic model was used to estimate 24-month clinical events, costs and quality-adjusted life year (QALY) gain for a Tack-supported versus status-quo PTA strategy. Patient and lesion characteristics and TLR rates were derived from the PTA cohort of the TOBA II clinical trial, an observational cohort, and literature. Cost–effectiveness was determined from a US payer and provider perspective separately for the non-severe (grade A or B), severe (grade C and higher) and the entire dissection cohort. Results: TLR rates were lower for the Tack-supported strategy compared with PTA (7.7 vs 27.4% in the non-severe, 13.9 vs 25.8% in the severe and 12.0 vs 26.3% in the entire dissection cohort). Cost and QALY differences were +$297/ + 0.0110 in the non-severe dissection cohort and - $1602/ + 0.0067 in the severe dissection cohort, resulting in an incremental cost–effectiveness ratio (ICER) of $25,622 in the non-severe cohort and dominance in the severe cohort and the entire cohort. Conclusion: Compared with a ‘status-quo’ approach, proactive focal stenting may lead to fewer reinterventions and improved quality of life. There appears to be a graded economic benefit of focal dissection treatment, being cost-effective in non-severe dissections and even cost saving in severe dissections.adverse effectsangioplastyballooncosts and cost analysisdissectionperipheral arterial disease
spellingShingle Jan B Pietzsch
Benjamin P Geisler
Abigail M Garner
Anne M Ryschon
William A Gray
Masahiko Fujihara
Peter A Schneider
Clinical and economic implications of focal dissection treatment following percutaneous transluminal angioplasty of the superficial femoral artery: an exploratory analysis based on the TOBA II Study
Journal of Comparative Effectiveness Research
adverse effects
angioplasty
balloon
costs and cost analysis
dissection
peripheral arterial disease
title Clinical and economic implications of focal dissection treatment following percutaneous transluminal angioplasty of the superficial femoral artery: an exploratory analysis based on the TOBA II Study
title_full Clinical and economic implications of focal dissection treatment following percutaneous transluminal angioplasty of the superficial femoral artery: an exploratory analysis based on the TOBA II Study
title_fullStr Clinical and economic implications of focal dissection treatment following percutaneous transluminal angioplasty of the superficial femoral artery: an exploratory analysis based on the TOBA II Study
title_full_unstemmed Clinical and economic implications of focal dissection treatment following percutaneous transluminal angioplasty of the superficial femoral artery: an exploratory analysis based on the TOBA II Study
title_short Clinical and economic implications of focal dissection treatment following percutaneous transluminal angioplasty of the superficial femoral artery: an exploratory analysis based on the TOBA II Study
title_sort clinical and economic implications of focal dissection treatment following percutaneous transluminal angioplasty of the superficial femoral artery an exploratory analysis based on the toba ii study
topic adverse effects
angioplasty
balloon
costs and cost analysis
dissection
peripheral arterial disease
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