RCT versus real-world cohorts: Differences in patient characteristics drive associations with outcome after EVT.


Journal

European stroke journal
ISSN: 2396-9881
Titre abrégé: Eur Stroke J
Pays: England
ID NLM: 101688446

Informations de publication

Date de publication:
03 2023
Historique:
received: 25 07 2022
accepted: 09 11 2022
medline: 7 4 2023
entrez: 6 4 2023
pubmed: 7 4 2023
Statut: ppublish

Résumé

The selection of patients with large-vessel occlusion (LVO) stroke for endovascular treatment (EVT) depends on patient characteristics and procedural metrics. The relation of these variables to functional outcome after EVT has been assessed in numerous datasets from both randomized controlled trials (RCT) and real-world registries, but whether differences in their case mix modulate outcome prediction is unknown. We leveraged data from individual patients with anterior LVO stroke treated with EVT from completed RCTs from the Virtual International Stroke Trials Archive ( Ten out of 11 analyzed baseline variables differed between the RCT and real-world cohort: RCT patients were younger, had higher admission NIHSS scores, and received thrombolysis more often (all RCT and real-world cohorts considerably differ in patient characteristics, individual outcome predictor strength, and overall outcome prediction model performance.

Sections du résumé

Background
The selection of patients with large-vessel occlusion (LVO) stroke for endovascular treatment (EVT) depends on patient characteristics and procedural metrics. The relation of these variables to functional outcome after EVT has been assessed in numerous datasets from both randomized controlled trials (RCT) and real-world registries, but whether differences in their case mix modulate outcome prediction is unknown.
Methods
We leveraged data from individual patients with anterior LVO stroke treated with EVT from completed RCTs from the Virtual International Stroke Trials Archive (
Results
Ten out of 11 analyzed baseline variables differed between the RCT and real-world cohort: RCT patients were younger, had higher admission NIHSS scores, and received thrombolysis more often (all
Conclusions
RCT and real-world cohorts considerably differ in patient characteristics, individual outcome predictor strength, and overall outcome prediction model performance.

Identifiants

pubmed: 37021166
doi: 10.1177/23969873221142642
pii: 10.1177_23969873221142642
pmc: PMC10069173
doi:

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Pagination

231-240

Informations de copyright

© European Stroke Organisation 2022.

Déclaration de conflit d'intérêts

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: LK has received funding for travel or speaker honoraria from Bayer Vital, Boehringer Ingelheim, Bristol-Meyer-Squibb, Daiichi Sankyo, and Pfizer outside of this study. MG reports personal fees from Medtronic, Stryker, Microvention, and Mentice, all outside the submitted work. In addition, MG has a patent on “Systems of acute stroke diagnosis” licensed to GE Healthcare, and a patent on “Systems of intracranial access” licensed to Microvention. CG reports personal fees from Amgen, Boehringer Ingelheim, Daiichi Sankyo, Abbott, Prediction Biosciences, Novartis, and Bayer, all outside the submitted work. GT reports grants and personal fees from Bayer, and personal fees from Acandis, BristolMyersSquibb/Pfizer, Boehringer Ingelheim, Daiichi Sankyo, Portola, and Stryker, all outside the submitted work. ST reports personal fees from Apollo Alpha, outside of the submitted work. All other authors declare no competing interests.

Références

Front Neurol. 2020 Dec 08;11:593238
pubmed: 33363508
Stroke. 2020 Jun;51(6):1781-1789
pubmed: 32390550
J Neurointerv Surg. 2021 Sep;13(9):790-793
pubmed: 32929047
BMJ. 2018 Mar 9;360:k949
pubmed: 29523557
Stroke. 2022 Mar;53(3):825-836
pubmed: 34732070
Stat Med. 2016 Oct 15;35(23):4136-52
pubmed: 27251001
Circulation. 2018 Jul 17;138(3):232-240
pubmed: 29581124
AJNR Am J Neuroradiol. 2010 Aug;31(7):1192-6
pubmed: 20223889
Stroke. 2020 Nov;51(11):3205-3214
pubmed: 33040702
Eur Heart J. 2017 Jun 14;38(23):1805-1814
pubmed: 27436868
Stroke. 2015 Jun;46(6):1727-34
pubmed: 25944325
JAMA. 2016 Sep 27;316(12):1279-88
pubmed: 27673305
J Neurointerv Surg. 2022 Nov;14(11):1145-1150
pubmed: 34876497
BMC Bioinformatics. 2011 Mar 17;12:77
pubmed: 21414208
Int J Stroke. 2017 Jul;12(5):494-501
pubmed: 27811307
BMJ. 2017 May 3;357:j1710
pubmed: 28468840
Stroke. 2013 Dec;44(12):3324-30
pubmed: 23929748
Neurology. 2020 Jul 14;95(2):e131-e139
pubmed: 32527972
Lancet. 2016 Apr 23;387(10029):1723-31
pubmed: 26898852
Stroke. 2019 Sep;50(9):2500-2506
pubmed: 31337298
Stroke. 2021 May;52(5):1921-1928
pubmed: 33765866

Auteurs

Fanny Quandt (F)

Department of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Nina Meißner (N)

Institute for Stroke and Dementia Research, University Hospital, LMU Munich, Munich, Germany.

Teresa A Wölfer (TA)

Institute for Stroke and Dementia Research, University Hospital, LMU Munich, Munich, Germany.

Fabian Flottmann (F)

Department of Diagnostic and Interventional Neuroradiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Milani Deb-Chatterji (M)

Department of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Lars Kellert (L)

Department of Neurology, University Hospital, LMU Munich, Munich, Germany.

Jens Fiehler (J)

Department of Diagnostic and Interventional Neuroradiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Mayank Goyal (M)

Department of Radiology, University of Calgary, Foothills Medical Centre, Calgary, AB, Canada.

Jeffrey L Saver (JL)

Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA.

Christian Gerloff (C)

Department of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Götz Thomalla (G)

Department of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Steffen Tiedt (S)

Institute for Stroke and Dementia Research, University Hospital, LMU Munich, Munich, Germany.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH