Abstract
Objective
Large hemispheric infarction (LHI) is associated with a high likelihood of the evolution of life-threatening edema. Few studies have assessed real-world clinical outcomes and management strategies among patients with LHI. The objective of this study was to describe the management, in-hospital outcomes, and direct healthcare resource burden of patients with LHI, as well as those of patients with subsequent cerebral edema.
Methods
This observational, retrospective cohort study analyzed de-identified data from US adult patients using the IBM MarketScan Hospital Drug Database (Q4-2015 to Q4-2017). Patients were included in the “Possible LHI” or the “Other Ischemic Strokes” cohorts using ICD-10 diagnosis codes. Patients with possible LHI were further categorized into “LHI with Edema” and “LHI without Edema” subgroups using diagnosis and procedure codes. Select clinical and economic outcomes were compared between cohorts and subgroups using multivariable regressions.
Results
Of 79,201 eligible encounters with ischemic strokes, 11,772 unique patients were assigned to the Possible LHI cohort while 67,429 were assigned to the Other Ischemic Strokes cohort. Among patients with possible LHI, 869 (7%) were assigned to the LHI with Edema subgroup and 10,903 (93%) were assigned to the LHI without Edema subgroup. Patients in the Possible LHI cohort had longer hospital stays (mean difference [MD] [95%CI] = 2.6 [2.4;2.8] days), higher total facility charges (MD [95%CI] = $28,656 [26,794;30,524]), and higher odds of death (odds ratio [95%CI] = 2.2 [2.0;2.4]) than the Other Ischemic Strokes cohort. Among patients with possible LHI, the incremental clinical and resource burden was further exacerbated in the subgroup of patients with edema (hospital days: MD [95%CI] = 5.0 [3.9;6.2] days; total facility charges: MD [95%CI] = $59,585 [50,816;67,583]; mortality: odds ratio [95%CI] = 10.3 [8.5;12.4]).
Conclusions
Among patients with ischemic strokes, LHI was associated with increased clinical management and direct healthcare resource burden in real-world hospital settings. The burden was substantially increased among patients who developed cerebral edema.
Transparency
Declaration of funding
Biogen provided funding for medical writing support in the development of this paper.
Declaration of financial/other relationships
This research was funded by Biogen, Inc. Biogen is the manufacturer of intravenous glibenclamide (BIIB093), an investigational compound under development for the treatment of severe cerebral edema in patients with acute ischemic stroke.
Dr. Shih-Yin Chen is an employee of Biogen and owns stock in the company. Mr. Thompson-Leduc, Ms. Fakih, Ms. Cheung, Ms. Macheca, and Dr. Kirson are employees and former employees of Analysis Group, Inc., a consultancy that has received research funding from Biogen for collaboration on this study. Dr. Sawyer and Dr. Torbey have no conflicts of interest to declare.
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Acknowledgements
The authors would like to thank Suzanne Douthwaite, CMPP, from Excel Scientific Solutions, and Adrienne Trout and Helen Donaghy from Alligent Europe Medical Affairs who copyedited and styled the manuscript per journal requirements. Biogen reviewed and provided feedback on the paper to the authors. S-YC, an employee of Biogen, was involved in the study design, the collection, analysis and interpretation of data, the writing of the report, and in the decision to submit the article for publication. All authors had full editorial control of the paper, and provided their final approval of all content. The corresponding author (S-YC) had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Institution where work was performed
Analysis Group, Inc.
Notes
i MarketScan is a registered trademark of IBM, Armonk, NY, USA.