Background The impact of intravenous (IV) thrombolysis on the outcomes of aspiration thrombectomy as the primary endovascular approach to stroke in patients with large vessel occlusion is unknown. Methods The Imperative Trial was a prospective, investigational device exemption, multicenter trial of first-line aspiration thrombectomy that assessed the safety and efficacy of the Zoom System, including a novel 0.088 inch aspiration catheter in patients with stroke within 8 hours of onset. We compared procedural, technical, and clinical outcomes of aspiration thrombectomy based on whether patients had received IV thrombolytics prior to the intervention. Results Among the 260 patients treated with front-line aspiration thrombectomy using the Zoom System, 125 (48%) received IV thrombolysis prior to aspiration. Rates of modified Thrombolysis in Cerebral Infarction (mTICI) ≥2b achieved with the Zoom System were higher in the aspiration-only group than in the combined group (92% vs 81%, P=0.016). Rates of mTICI ≥2c and first pass effect were similar. The use of rescue devices to achieve mTICI ≥2b was less frequent in the aspiration-only group than in the combined group (2% vs 10%, P=0.008). The rates of functional independence (modified Rankin Scale (mRS) score 0–2) in the aspiration-only group and the combined group were 50% and 59%, respectively (P=0.16). Univariate (P=0.30) and multivariate (P=0.47) ordinal regression analyses showed no significant correlation of mRS 0–2 with IV thrombolysis. Both groups had similar safety outcomes including rates of symptomatic intracranial hemorrhage and 90-day mortality. Conclusions Aspiration thrombectomy alone may result in higher rates of successful reperfusion and reduce the need for rescue devices compared with the combined approach with IV thrombolysis.
Mokin et al. (Tue,) studied this question.