Real world data in mechanical thrombectomy: who are we losing to follow-up?
Stroke
Thrombectomy
Journal
Journal of neurointerventional surgery
ISSN: 1759-8486
Titre abrégé: J Neurointerv Surg
Pays: England
ID NLM: 101517079
Informations de publication
Date de publication:
17 Jul 2023
17 Jul 2023
Historique:
received:
17
04
2023
accepted:
07
06
2023
medline:
18
7
2023
pubmed:
18
7
2023
entrez:
17
7
2023
Statut:
aheadofprint
Résumé
Missing outcome data (MOD) is a common problem in clinical trials and registries, and a potential bias when drawing conclusions from these data. Identifying factors associated with MOD may help to increase follow-up rates and assess the need for imputation strategies. We investigated MOD in a multicenter, prospective registry study of mechanical thrombectomy (MT) in large vessel occlusion ischemic stroke. 13 082 patients enrolled in the German Stroke Registry-Endovascular Treatment from May 2015 to December 2021 were analyzed with regard to MOD (90 day modified Rankin Scale, mRS). Univariate logistic regression analyses identified factors unbalanced between patients with and without MOD. Subgroup analyses were performed to identify patients for whom increased efforts to perform clinical follow-up after hospital discharge are needed. We identified 19.7% (2580/13 082) of patients with MOD at the 90 day follow-up. MOD was more common with higher pre-stroke disability (mRS 3-5, 32.2% vs mRS 0-2, 13.7%; P<0.001), absence of bridging intravenous thrombolysis, longer time to treatment, and in patients with high post-stroke disability at discharge (mRS 3-5 vs 0-2: OR 1.234 (95% CI 1.107 to 1.375); P<0.001). In contrast, MOD was less common with futile recanalization (thrombolysis in cerebral infarction (TICI) score of 0-2a, 12.4% vs TICI 2b-3, 15.0%; P=0.001). In patients discharged alive with well documented baseline characteristics, shorter hospital stay (OR 0.992 (95% CI 0.985 to 0.998); P=0.010) and discharge to institutional care or hospital (OR 1.754 (95% CI 1.558 to 1.976); P<0.001) were associated with MOD. MOD in routine care MT registry data was not random. Increased efforts to perform clinical follow-up are needed, especially in the case of higher pre-stroke and post-stroke disability and discharge to hospital or institutional care. NCT03356392.
Sections du résumé
BACKGROUND
BACKGROUND
Missing outcome data (MOD) is a common problem in clinical trials and registries, and a potential bias when drawing conclusions from these data. Identifying factors associated with MOD may help to increase follow-up rates and assess the need for imputation strategies. We investigated MOD in a multicenter, prospective registry study of mechanical thrombectomy (MT) in large vessel occlusion ischemic stroke.
METHODS
METHODS
13 082 patients enrolled in the German Stroke Registry-Endovascular Treatment from May 2015 to December 2021 were analyzed with regard to MOD (90 day modified Rankin Scale, mRS). Univariate logistic regression analyses identified factors unbalanced between patients with and without MOD. Subgroup analyses were performed to identify patients for whom increased efforts to perform clinical follow-up after hospital discharge are needed.
RESULTS
RESULTS
We identified 19.7% (2580/13 082) of patients with MOD at the 90 day follow-up. MOD was more common with higher pre-stroke disability (mRS 3-5, 32.2% vs mRS 0-2, 13.7%; P<0.001), absence of bridging intravenous thrombolysis, longer time to treatment, and in patients with high post-stroke disability at discharge (mRS 3-5 vs 0-2: OR 1.234 (95% CI 1.107 to 1.375); P<0.001). In contrast, MOD was less common with futile recanalization (thrombolysis in cerebral infarction (TICI) score of 0-2a, 12.4% vs TICI 2b-3, 15.0%; P=0.001). In patients discharged alive with well documented baseline characteristics, shorter hospital stay (OR 0.992 (95% CI 0.985 to 0.998); P=0.010) and discharge to institutional care or hospital (OR 1.754 (95% CI 1.558 to 1.976); P<0.001) were associated with MOD.
CONCLUSION
CONCLUSIONS
MOD in routine care MT registry data was not random. Increased efforts to perform clinical follow-up are needed, especially in the case of higher pre-stroke and post-stroke disability and discharge to hospital or institutional care.
TRIAL REGISTRATION
BACKGROUND
NCT03356392.
Identifiants
pubmed: 37460214
pii: jnis-2023-020435
doi: 10.1136/jnis-2023-020435
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT03356392']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Investigateurs
Joachim Röther
(J)
Bernd Eckert
(B)
Michael Braun
(M)
Gerhard F Hamann
(GF)
Eberhard Siebert
(E)
Christian H Nolte
(CH)
Sarah Zweynert
(S)
Georg Bohner
(G)
Jörg Berrouschot
(J)
Albrecht Bormann
(A)
Christoffer Kraemer
(C)
Martina Petersen
(M)
Florian Stögbauer
(F)
Tobias Boeckh-Behrens
(T)
Silke Wunderlich
(S)
Alexander Ludolph
(A)
Karl-Heinz Henn
(KH)
Christian Gerloff
(C)
Jens Fiehler
(J)
Götz Thomalla
(G)
Anna Alegiani
(A)
Franziska Dorn
(F)
Gabor Petzold
(G)
Waltraud Pfeilschifter
(W)
Fee Keil
(F)
Martin Dichgans
(M)
Steffen Tiedt
(S)
Lars Kellert
(L)
Christoph Trumm
(C)
Ulrike Ernemann
(U)
Sven Poli
(S)
Informations de copyright
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: AO reports speakers bureau from Cerenovus and Canon Medical. KG reports personal fees and/or non-financial support from Bayer, Boehringer Ingelheim, Bristol-Meyers Squibb, Daiichi Sankyo, and Pfizer. MH reports personal fees from Bristol-Meyers Squibb, outside of the submitted work. TU reports personal fees from Merck Serono and Pfizer, and grants from Else Kröner-Fresenius Stiftung.