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Published on: January 8, 2020
Patient outcomes in historical comparators compared with randomised-controlled trials.
1Division of Cardiovascular and Medical Sciences, Gardiner Institute, Western Infirmary, Glasgow, UK. myzoonali@clinmed.gla.ac.uk
Summary
Decompressive hemicraniectomy for malignant middle cerebral artery infarction did not show improved survival in this study using historical controls. Historical data may not accurately represent patients in clinical trials, impacting results.
Area of Science:
- Neurology
- Neurosurgery
- Critical Care Medicine
Background:
- Decompressive hemicraniectomy for malignant middle cerebral artery infarction remains controversial.
- Randomized controlled trials (RCTs) demonstrate improved outcomes but are ethically challenging due to high control group mortality.
- Historical comparators may offer insights for trial design when RCTs are infeasible.
Purpose of the Study:
- To evaluate if historical comparator data from the Virtual International Stroke Trials Archive (VISTA) can replicate the findings of the DESTINY trial.
- To determine the feasibility of using historical controls in situations where RCTs for decompressive surgery are unethical.
Main Methods:
- Data extraction from VISTA for patients with malignant middle cerebral artery infarction (NIHSS ≥ 20, LOC1A ≥ 1, lesion volume ≥ 145 cm³).
- Comparison of functional outcomes (modified Rankin Scale, Barthel Index) and 90-day survival rates between VISTA comparators and DESTINY surgical group.
- Statistical analysis using chi-squared tests, logistic regression, Kaplan-Meier analysis, and Cox proportional hazards models, adjusting for baseline NIHSS and age.
Main Results:
- The DESTINY surgical group showed a significantly better functional outcome (mRS) compared to VISTA comparators (47% vs. 19%, P=0.04).
- No significant difference in Barthel Index was observed, though a trend favored the DESTINY group.
- Unlike the DESTINY trial, no significant difference in 90-day survival rates was found between the surgical and VISTA comparator groups (88% vs. 72%, P=0.24).
Conclusions:
- The survival benefits of decompressive hemicraniectomy were not confirmed using the VISTA historical comparator dataset.
- Discrepancies may arise from the exclusion of malignant middle cerebral artery infarction patients from efficacy trials and potential non-representativeness of VISTA data.
- Enhancing VISTA with data from population-based studies and stroke registries could improve the utility of historical comparators.
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