Abstract WP31: A Comparison of Outcomes Associated With Mechanical Thrombectomy in Acute Ischemic Stroke Patients Performed Within and Outside Clinical Trials in the United States

Abstract

Background: A discrepancy between characteristics of patients treated with mechanical thrombectomy in acute ischemic stroke patients within and outside clinical trials, particularly characteristics with direct impact on clinical outcome, may limit generalization of clinical trial results. The objective of this study was to identify differences in demographic and clinical characteristics and outcomes related to mechanical thrombectomy in patients treated in clinical trials and those treated outside clinical trials in a large national cohort. Methods: We determined the frequency of mechanical thrombectomy in acute ischemic stroke patients performed within and outside clinical trials and associated in-hospital outcomes using nationally representative data from the Nationwide Inpatient Survey data files from 2013 to 2015. We compared in-hospital mortality and discharge to home in patients who were treated within and outside the clinical trials. Results: Of the 23,375 patients who underwent mechanical thrombectomy, 430 (1.8%) underwent the procedure as part of a clinical trial. There was no difference in mean age of the patients treated with mechanical thrombectomy as part of a clinical trial than those treated with thrombectomy outside a clinical trial. The proportion of women was lower among patients treated with thrombectomy as part of a clinical trial. After adjusting for age, mechanical thrombectomy performed as part of a clinical trial was associated with lower rates of in-hospital mortality (odds ratio [OR]: 0.13; 95% confidence interval [CI]: 0.03-0.55; P = .002) and higher rates of discharge to home (OR, 2.5; 95% CI, 1.6-3.9; P = .003). Conclusions: Our results suggest that mechanical thrombectomy procedures performed as part of clinical trials were associated with lower rates of in-hospital mortality and higher rates of discharge home in the United States. These findings highlight the need for strategies that ensure appropriate adoption of mechanical thrombectomy to ensure that the benefits observed in clinical trials can be replicated in general practice.