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Randomized Controlled Trial
. 2021 Mar;61(3):447-455.
doi: 10.1016/j.ejvs.2020.11.030. Epub 2021 Jan 5.

Editor's Choice - A Cost Effectiveness Analysis of Outpatient versus Inpatient Hospitalisation for Lower Extremity Arterial Disease Endovascular Revascularisation in France: A Randomised Controlled Trial

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Randomized Controlled Trial

Editor's Choice - A Cost Effectiveness Analysis of Outpatient versus Inpatient Hospitalisation for Lower Extremity Arterial Disease Endovascular Revascularisation in France: A Randomised Controlled Trial

Yann Gouëffic et al. Eur J Vasc Endovasc Surg. 2021 Mar.
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Abstract

Objective: The AMBUVASC trial evaluated the cost effectiveness of outpatient vs. inpatient hospitalisation for endovascular repair of lower extremity arterial disease (LEAD).

Methods: AMBUVASC was a national multicentre, prospective, randomised controlled trial conducted in nine public and two private French centres. The primary endpoint was the incremental cost effectiveness ratio (ICER), defined by cost per quality adjusted life year (QALY). Analysis was conducted from a societal perspective, excluding indirect costs, and considering a one month time horizon.

Results: From 16 February 2016 to 29 May 2017, 160 patients were randomised (80 per group). A modified intention to treat analysis was performed with 153 patients (outpatient hospitalisation: n = 76; inpatient hospitalisation: n = 77). The patients mainly presented intermittent claudication (outpatient arm: 97%; inpatient arm: 92%). Rates of peri-operative complications were 20% (15 events) and 18% (14 events) for the outpatient and inpatient arms respectively (p = .81). Overall costs (difference: €187.83; 95% confidence interval [CI] -275.68-651.34) and QALYs (difference: 0.00277; 95% CI -0.00237 - 0.00791) were higher for outpatients due to more re-admissions than the inpatient arm. The mean ICER was €67 741 per QALY gained for the base case analysis with missing data imputed using multiple imputation by predictive mean matching. The outpatient procedure was not cost effective for a willingness to pay of €50 000 per QALY and the probability of being cost effective was only 59% for a €100 000/QALY threshold.

Conclusion: Outpatient hospitalisation is not cost effective compared with inpatient hospitalisation for endovascular repair of patients with claudication at a €50 000/QALY threshold.

Keywords: Conventional hospitalisation; Cost effectiveness; Endovascular; Outpatient; Peripheral arterial occlusive disease.

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Conflict of interest statement

Conflict of interest Yann Gouëffic reports research funding from Bard, Medtronic, Terumo, and WL Gore; and personal fees and grants from Abbott, Bard, Biotronik, Boston Scientific, Medtronic, Terumo, Vygon, and WL Gore (medical advisory board, educational course, speaking). Jean Luc Pin reports personal fees from Biotronic, grants from Boston, personal fees from Bard, personal fees from Abbott, outside the submitted work. Eric Steinmetz reports grants and personal fees from Biotronik, grants from Boston Scientific, grants from CR Bard, outside the submitted work. Pierre-Edouard Magnan reports grants from Government, during the conduct of the study; grants from COOK aortic, grants from Bard, outside the submitted work. Jean Sabatier, Yves Alimi, Olivier Marret, Adrien Kaladji, Bertrand Chavent, Benjamin Kretz, Alexandra Jobert, Béatrice Guyomarc'h, and Lucie Salomon du Mont have nothing to disclose. Solène Schirr-Bonnans, Valéry Pierre Riche, and Philippe Tessier report grants from French Ministry of Health, during the conduct of the study.

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