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Review
. 2022 Dec 7;12(12):1679.
doi: 10.3390/brainsci12121679.

Common Data Elements Reported in Mechanical Thrombectomy for Acute Ischemic Stroke: A Systematic Review of Active Clinical Trials

Sherief Ghozy  1 , Nicole Hardy  2 , Daniel J Sutphin  3 , Kevin M Kallmes  2 , Ramanathan Kadirvel  1   4 , David F Kallmes  1
Affiliations
Review

Common Data Elements Reported in Mechanical Thrombectomy for Acute Ischemic Stroke: A Systematic Review of Active Clinical Trials

Sherief Ghozy et al. Brain Sci. .

Abstract

Background: New trials are planned regularly to provide the highest quality of evidence and invade new occlusion territories, which requires a pre-defined reporting strategy with consistent, common data elements for more straightforward collective evidence synthesis. We sought to review all active endovascular thrombectomy trials to investigate their patient selection criteria, intervention description, and reported outcomes.

Methods: A literature search was systematically conducted on clinicaltrials.gov for active trials and all intervention, inclusion criteria, and outcomes reported were extracted. A qualitative synthesis of the frequency of study design types and data elements are graphically and narratively presented.

Results: A total of 32 studies were tagged and included in the final qualitative analysis. The inclusion criteria were highly variable, including different cut-offs for the last well-known baseline National Institutes of Health Stroke Scale, Alberta Stroke Program Early CT Score, and modified Rankin scale (mRS). Half of the studies (16/32) mentioned "thrombectomy" without defining which technique or device was used, and the final thrombolysis in cerebral infarction scale was provided in 19 (59.4%) studies. Heterogeneity was also present among the studies reporting a first-pass effect, both in how studies defined the outcome and in used ranges for mRS. Mortality and intracerebral hemorrhage (ICH) were more homogenous in their presentation and follow-up.

Conclusions: There is a great degree of heterogeneity in the active thrombectomy trials concerning inclusion criteria, interventions used, and how outcomes are being reported.

Keywords: clinical Trial; common data elements; stroke; thrombectomy.

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Conflict of interest statement

K.M.K. works for and holds equity in Nested Knowledge, Inc., works for Conway Medical LLC, and holds equity in Superior Medical Experts, Inc. D.F.K. has the following conflicts: ownership in Nested Knowledge, Inc., Superior Medical Experts, Inc., Conway Medical LLC; research support from Microvention, Balt USA, Medtronic.

Figures

Figure 1
Figure 1
(A) Distribution of inclusion criteria among different studies. (B). Heterogeneity in different cut-offs used within inclusion criteria.
Figure 1
Figure 1
(A) Distribution of inclusion criteria among different studies. (B). Heterogeneity in different cut-offs used within inclusion criteria.
Figure 2
Figure 2
Distribution of used interventions among different studies.
Figure 3
Figure 3
(A) Distribution of reported outcomes among different studies. mRS: the modified Rankin Scale; ICH: intracerebral hemorrhage; TICI: the Thrombolysis in Cerebral Infarction scale; FPE: first-pass effect; ENT: emboli to new territories. (B) Heterogeneity in the reported outcomes.
Figure 3
Figure 3
(A) Distribution of reported outcomes among different studies. mRS: the modified Rankin Scale; ICH: intracerebral hemorrhage; TICI: the Thrombolysis in Cerebral Infarction scale; FPE: first-pass effect; ENT: emboli to new territories. (B) Heterogeneity in the reported outcomes.
Figure 4
Figure 4
Frequency of uncommon, heterogeneously presented data elements. SAE: serious adverse events; NIHSS: National Institutes of Health Stroke Scale; QOL: quality of life; UW-mRS: utility-weighted modified Rankin Scale.
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References

    1. Feigin V.L., Stark B.A., Johnson C.O., Roth G.A., Bisignano C., Abady G.G., Abbasifard M., Abbasi-Kangevari M., Abd-Allah F., Abedi V., et al. Global, regional, and national burden of stroke and its risk factors, 1990–2019: A systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021;20:795–820. doi: 10.1016/S1474-4422(21)00252-0. - DOI - PMC - PubMed
    1. Albers G.W., Marks M.P., Kemp S., Christensen S., Tsai J.P., Ortega-Gutierrez S., McTaggart R.A., Torbey M.T., Kim-Tenser M., Leslie-Mazwi T., et al. Thrombectomy for Stroke at 6 to 16 Hours with Selection by Perfusion Imaging. N. Engl. J. Med. 2018;378:708–718. doi: 10.1056/NEJMoa1713973. - DOI - PMC - PubMed
    1. Dhillon P.S., Butt W., Podlasek A., McConachie N., Lenthall R., Nair S., Malik L., Bhogal P., Makalanda H.L.D., Spooner O., et al. Association between time to treatment and clinical outcomes in endovascular thrombectomy beyond 6 hours without advanced imaging selection. J. Neurointerv. Surg. 2022 doi: 10.1136/neurintsurg-2021-018564. - DOI - PubMed
    1. Jovin T.G., Chamorro A., Cobo E., de Miquel M.A., Molina C.A., Rovira A., San Román L., Serena J., Abilleira S., Ribó M., et al. Thrombectomy within 8 hours after symptom onset in ischemic stroke. N. Engl. J. Med. 2015;372:2296–2306. doi: 10.1056/NEJMoa1503780. - DOI - PubMed
    1. Nogueira R.G., Jadhav A.P., Haussen D.C., Bonafe A., Budzik R.F., Bhuva P., Yavagal D.R., Ribo M., Cognard C., Hanel R.A., et al. Thrombectomy 6 to 24 Hours after Stroke with a Mismatch between Deficit and Infarct. N. Engl. J. Med. 2018;378:11–21. doi: 10.1056/NEJMoa1706442. - DOI - PubMed

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