Endovascular thrombectomy in patients with large core ischemic stroke: a cost-effectiveness analysis from the SELECT study.


Journal

Journal of neurointerventional surgery
ISSN: 1759-8486
Titre abrégé: J Neurointerv Surg
Pays: England
ID NLM: 101517079

Informations de publication

Date de publication:
Oct 2021
Historique:
received: 20 08 2020
revised: 16 10 2020
accepted: 19 10 2020
pubmed: 15 11 2020
medline: 18 9 2021
entrez: 14 11 2020
Statut: ppublish

Résumé

It is unknown whether endovascular thrombectomy (EVT) is cost effective in large ischemic core infarcts. In the prospective, multicenter, cohort study of imaging selection study (SELECT), large core was defined as computed tomography (CT) ASPECTS<6 or computed tomography perfusion (CTP) ischemic core volume (rCBF<30%) ≥50 cc. A Markov model estimated costs, quality-adjusted life years (QALYs) and the incremental cost-effectiveness ratio (ICER) of EVT compared with medical management (MM) over lifetime. The willingness to pay (WTP) per QALY was set at $50 000 and $100 000 and the net monetary benefits (NMB) were calculated. Probabilistic sensitivity analysis (PSA) and cost-effectiveness acceptability curves (CEAC) for EVT were assessed in SELECT and other pivotal trials. From 361 patients enrolled in SELECT, 105 had large core on CT or CTP (EVT 62, MM 43). 19 (31%) EVT vs 6 (14%) MM patients achieved modified Rankin Scale (mRS) score 0-2 (OR 3.27, 95% CI 1.11 to 9.62, P=0.03) with a shift towards better mRS (cOR 2.12, 95% CI 1.05 to 4.31, P=0.04). Over the projected lifetime of patients presenting with large core, EVT led to incremental costs of $33 094 and a gain of 1.34 QALYs per patient, resulting in ICER of $24 665 per QALY. EVT has a higher NMB compared with MM at lower (EVT -$42 747, MM -$76 740) and upper (EVT $155 041, MM $57 134) WTP thresholds. PSA confirmed the results and CEAC showed 77% and 92% acceptability of EVT at the WTP of $50 000 and $100 000, respectively. EVT was associated with an increment of $29 225 in societal costs. The pivotal EVT trials (HERMES, DAWN, DEFUSE 3) were dominant in a sensitivity analysis at the same inputs, with societal cost-savings of $37 901, $86 164 and $22 501 and a gain of 1.62, 2.36 and 2.21 QALYs, respectively. In a non-randomized prospective cohort study, EVT resulted in better outcomes in large core patients with higher QALYs, NMB and high cost-effectiveness acceptability rates at current WTP thresholds. Randomized trials are needed to confirm these results. NCT02446587.

Sections du résumé

BACKGROUND BACKGROUND
It is unknown whether endovascular thrombectomy (EVT) is cost effective in large ischemic core infarcts.
METHODS METHODS
In the prospective, multicenter, cohort study of imaging selection study (SELECT), large core was defined as computed tomography (CT) ASPECTS<6 or computed tomography perfusion (CTP) ischemic core volume (rCBF<30%) ≥50 cc. A Markov model estimated costs, quality-adjusted life years (QALYs) and the incremental cost-effectiveness ratio (ICER) of EVT compared with medical management (MM) over lifetime. The willingness to pay (WTP) per QALY was set at $50 000 and $100 000 and the net monetary benefits (NMB) were calculated. Probabilistic sensitivity analysis (PSA) and cost-effectiveness acceptability curves (CEAC) for EVT were assessed in SELECT and other pivotal trials.
RESULTS RESULTS
From 361 patients enrolled in SELECT, 105 had large core on CT or CTP (EVT 62, MM 43). 19 (31%) EVT vs 6 (14%) MM patients achieved modified Rankin Scale (mRS) score 0-2 (OR 3.27, 95% CI 1.11 to 9.62, P=0.03) with a shift towards better mRS (cOR 2.12, 95% CI 1.05 to 4.31, P=0.04). Over the projected lifetime of patients presenting with large core, EVT led to incremental costs of $33 094 and a gain of 1.34 QALYs per patient, resulting in ICER of $24 665 per QALY. EVT has a higher NMB compared with MM at lower (EVT -$42 747, MM -$76 740) and upper (EVT $155 041, MM $57 134) WTP thresholds. PSA confirmed the results and CEAC showed 77% and 92% acceptability of EVT at the WTP of $50 000 and $100 000, respectively. EVT was associated with an increment of $29 225 in societal costs. The pivotal EVT trials (HERMES, DAWN, DEFUSE 3) were dominant in a sensitivity analysis at the same inputs, with societal cost-savings of $37 901, $86 164 and $22 501 and a gain of 1.62, 2.36 and 2.21 QALYs, respectively.
CONCLUSIONS CONCLUSIONS
In a non-randomized prospective cohort study, EVT resulted in better outcomes in large core patients with higher QALYs, NMB and high cost-effectiveness acceptability rates at current WTP thresholds. Randomized trials are needed to confirm these results.
CLINICAL TRIAL REGISTRATION BACKGROUND
NCT02446587.

Identifiants

pubmed: 33188155
pii: neurintsurg-2020-016766
doi: 10.1136/neurintsurg-2020-016766
doi:

Banques de données

ClinicalTrials.gov
['NCT02446587']

Types de publication

Journal Article Multicenter Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

875-882

Informations de copyright

© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: AS reports serving as the principal investigator of the SELECT 2: A Randomized Controlled Trial to Optimize Patient’s Selection for Endovascular Treatment in Acute Ischemic Stroke trial, with an unrestricted grant from Stryker Neurovascular to University of Texas McGovern–Houston; as a consultant, speaker bureau member, and advisory board member for Stryker. EP is supported by the National Institute for Health Research ARC North Thames. The views expressed in this paper are those of the authors and not necessarily those of the National Institute for Health Research or the Department of Health and Social Care. KL reports institutional grants from Microvention and serving as a consultant for Microvention, Medtronic and Stryker. JCG reports research grants from Patient-Centered Outcomes Research Institute, National Institutes of Health, Genentech and CSL Behring and serving as a consultant for Frazier Ltd. AEH is a consultant, speaker bureau member, and proctor for Medtronic and Microvention and a consultant and speaker bureau member for Stryker, Penumbra, GE Healthcare, Balt and Genentech. MGA reports serving as a consultant for Stryker Neurovascular and Penumbra Inc. SB reports a research grant from National Institutes of Health. WH reports serving on the speaker bureau of BMS/Pfizer and Portola. MGL reports serving as a consultant for Biogen, Genentech, NuvOx Pharma and Nektar Therapeutics. RG reports serving as the principal investigator for ASSIST Registry funded by Stryker Neurovascular, for RECCLAIM II funded by Zoll Therapeutics, for Tiger Study funded by Rapid Medical and serving on the clinical endpoint committee for MIND Trial funded by Penumbra. GWA reports serving as the principal investigator for DEFUSE 3 trial funded by National Institute of Neurological Disorders and Stroke and as a consultant for Genentech and iSchemaView. He also reports an ownership interest in iSchemaView. WGK reports grant funding from the German Research Foundation and Ludwig-Maximilian-University Munich.

Auteurs

Amrou Sarraj (A)

Neurology, University of Texas McGovern Medical School, Houston, Texas, USA Amrou.Sarraj@uth.tmc.edu.

Elena Pizzo (E)

Department of Applied Health Research, University College London, London, UK.

Kyriakos Lobotesis (K)

Imaging Department, Imperial College Healthcare NHS Trust, London, UK.

James C Grotta (JC)

Clinical Institute for Research and Innovation, Memorial Hermann Texas Medical Center, Houston, Texas, USA.

Ameer E Hassan (AE)

Department of Neurology, University of Texas Rio Grande Valley, Harlingen, Texas, USA.

Michael G Abraham (MG)

University of Kansas Medical Center, Kansas City, Kansas, USA.

Spiros Blackburn (S)

Neurosurgery, University of Texas McGovern Medical School, Houston, Texas, USA.

Arthur L Day (AL)

Neurosurgery, University of Texas McGovern Medical School, Houston, Texas, USA.

Mark J Dannenbaum (MJ)

Neurosurgery, University of Texas McGovern Medical School, Houston, Texas, USA.

William Hicks (W)

Riverside Methodist Hospital, Columbus, Ohio, USA.

Nirav A Vora (NA)

Riverside Methodist Hospital, Columbus, Ohio, USA.

Ronald F Budzik (RF)

Riverside Methodist Hospital, Columbus, Ohio, USA.

Anjail Z Sharrief (AZ)

Neurology, University of Texas McGovern Medical School, Houston, Texas, USA.

Sheryl Martin-Schild (S)

Touro Infirmary, New Orleans, Louisiana, USA.
New Orleans East Hospital, New Orleans, Louisiana, USA.

Clark W Sitton (CW)

Diagnostic & Interventional Imaging, University of Texas McGovern Medical School, Houston, Texas, USA.

Deep Kiritbhai Pujara (DK)

Neurology, University of Texas McGovern Medical School, Houston, Texas, USA.

Maarten G Lansberg (MG)

Department of Neurology, Stanford University, Stanford, California, USA.

Rishi Gupta (R)

Neurosurgery, WellStar Health System, Marietta, Georgia, USA.

Gregory W Albers (GW)

Department of Neurology, Stanford University, Stanford, California, USA.

Wolfgang G Kunz (WG)

Department of Radiology, University Hospital Munich, Munich, Germany.

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Classifications MeSH