Dataset Information

Does variability in automated perfusion software outputs for acute ischemic stroke matter? Reanalysis of EXTEND perfusion imaging.

ABSTRACT:

Aims

We reprocessed the Extending the time for Thrombolysis in Emergency Neurological Deficits (EXTEND) perfusion imaging with a different automated software with the aim of comparing mismatch eligibility and outcomes.

Methods

EXTEND baseline perfusion imaging data were reprocessed using autoMIStar software to identify patients who were eligible based on the same target mismatch criteria as per the original trial.

Results

From the 225 patients fulfilling RAPID-based mismatch criteria randomized in the EXTEND study, 196 (87%) patients met the revised mismatch criteria. Most common reasons for not meeting revised criteria were core >70 ml (n = 9), and no perfusion lesion/lack of penumbral tissue (n = 20). The revised perfusion lesion volumes were significantly smaller compared to the original RAPID volumes (median 68 ml IQR 34-102 ml vs. 42 ml 16-92 ml, p = 0.036). Of the patients who met the revised mismatch criteria, 40% receiving alteplase had modified Rankin Scale (mRS) 0-1 at 3-month compared to 28% with placebo (Adjusted Odds Ratio (OR) = 2.23, CI 1.08-4.58, p = 0.028). In contrast, in the original mismatch cohort, 35% receiving alteplase had mRS 0-1 at 3-month compared to 30% with placebo (adjusted OR = 1.88, p = 0.056).

Conclusions

These data reinforce the benefit of alteplase in the later time window, and suggest that differences in automated perfusion imaging software outputs may be clinically relevant.

SUBMITTER: Bivard A

PROVIDER: S-EPMC8673699 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background:Stroke is a sudden interruption in the blood supply to a part of the brain, causing loss of neurological function. It is the third leading cause of death in Canada and affects mainly older people. In the acute setting, neuroimaging is integral to stroke evaluation and decision-making. The neuroimaging results guide patient selection for mechanical thrombectomy. Using automated image processing techniques facilitates efficient review of this information and communication between centres. We conducted a health technology assessment of automated CT perfusion imaging as a tool for selecting stroke patients with anterior circulation occlusion for mechanical thrombectomy. This assessment included an evaluation of clinical effectiveness, cost-effectiveness, and the budget impact of publicly funding automated CT perfusion imaging. Methods:We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each study using QUADAS-2 or the Cochrane risk-of-bias tool, and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and approximated cost-effectiveness based on previous analyses. We also analyzed the budget impact of publicly funding automated CT perfusion imaging to evaluate people with acute ischemic stroke in Ontario. Results:Automated CT perfusion imaging had a sensitivity of 84% for identifying the infarct core (dead tissue that does not recover despite restoring blood flow with mechanical thrombectomy), compared with diffusion-weighted MRI imaging at 24 hours. One study reported that 7% of patients were misclassified with respect to eligibility for mechanical thrombectomy (either erroneously classified as eligible or erroneously classified non-eligible). Two randomized controlled trials (DEFUSE 3 and DAWN) demonstrated the efficacy of mechanical thrombectomy up to 24 hours after stroke onset, with patient selection guided by automated CT perfusion imaging. These data showed that a significantly higher proportion of patients in the mechanical thrombectomy group achieved functional independence compared with the standard care group (DEFUSE 3: risk ratio: 2.67 [95% confidence interval 1.60-4.48]; DAWN: adjusted rate difference: 33% [95% credible interval 21%-44%]; GRADE: Moderate).A previous health technology assessment in stroke patients presenting at 0 to 6 hours after stroke symptom onset and the results from recent randomized controlled trials for patients presenting at 6 to 24 hours informed the evaluation of cost-effectiveness. Mechanical thrombectomy informed by automated CT perfusion imaging to assess eligibility is likely to be cost-effective for patients presenting at 6 to 24 hours after stroke symptom onset. The annual budget impact of publicly funding automated CT perfusion imaging in Ontario over the next 5 years would be $1.3 million in year 1 and $0.9 million each year thereafter. Some of the costs of automated CT perfusion imaging could be offset by avoiding unnecessary patient transfers between hospitals. Conclusions:Automated CT perfusion imaging has an acceptable sensitivity and specificity for detecting brain areas that have been affected by stroke. In patients selected for mechanical thrombectomy using automated CT perfusion imaging, there was significant improvement in functional independence. Mechanical thrombectomy informed by automated CT perfusion imaging is likely to be cost-effective. We estimate that publicly funding automated CT perfusion imaging in Ontario would result in additional costs of $1.3 million in year 1 and $0.9 million per year thereafter.