Abstract

Background: Using the pooled database of the DEVT and the RESCUE BT Trial, the objective of this study was to assess the serious adverse events (SAE) profile and their clinical impacts among patients with ischemic stroke due to large vessel occlusion treated with endovascular thrombectomy. Methods: A post hoc analysis was performed by using database of the multicenter, randomized DEVT and RESCUE BT clinical trials. SAEs as reported by investigators at any time-point during the hospitalization and the 90-day follow-up period were analyzed on their frequency and that of any of their outcomes (death, and life threatening, new and/or prolonged hospitalization, disability/incapacity). The primary end point was favorable outcome, as defined by a score of 0 or 1 on the modified Rankin scale (mRS) of neurologic disability (which ranges from 0 [no symptoms] to 6 [death]) at 90 days. Logistic regression analysis was used to determine the effect of SAE on clinical outcome and the predictors of SAE. Results: Among 1182 randomized patients undergone endovascular thrombectomy, 1758 SAE occurrences were identified, affecting 828 (70.1%) patients. The three most frequent SAEs were pneumonia (n=620, 52.5%), intracranial hemorrhage within 48 hours (n=359, 30.4%) and systemic bleeding (n=174, 14.7%). Patients suffering from at least one SAE had a lower odds of reaching a favorable outcome at 90 days (adjusted odds ratio, 0.350 [95% CI, 0.249-0.492], P <0.001). Higher age ( P =0.001), higher NIHSS ( P <0.001), intracranial segment of internal carotid artery (ICA) ( P =0.012) and puncture to recanalization time ( P <0.001) were predictors for the occurrence of SAE. Conclusions: SAEs were observed in about 7 in ten patients, and were more frequent in elderly, functionally-impaired, longer procedure time, and intracranial ICA-occluded among patients with ischemic stroke treated with endovascular thrombectomy. These findings may provide clinicians and patients with more accurate risk of SAEs after endovascular thrombectomy.

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