Effectiveness and safety of ultrasound-enhanced thrombolysis for acute ischemic stroke

Objective To evaluate the effectiveness and safety of ultrasound-enhanced thrombolysis for acute ischemic stroke. Methods Fifty stroke patients with acute middle cerebral artery occlusion were randomly divided into either a ultrasound-enhanced thrombolysis group (recombinant tissue-plasminogen activator [rtPA]+ 2 MHz ultrasound monitoring for 2 h) or a standard thrombolysis group (rtPA alone). The demographic characteristics, vascular risk factors, blood pressure before treatment, thrombolysis in brain ischemia (TIBI) grade before thrombosis, and vascular occlusion site of the patients were collected. The primary outcome endpoint was the good outcome rate (defined as the modified Rankin Scale score 0-1) at 3 months. The secondary outcome endpoints were complete recanalization at 2 h after thrombolysis, sustained complete recanalization, symptomatic intracerebral hemorrhage, and mortality. Results The good outcome rate of the ultrasound-enhanced thrombolysis group at 3 months after treatment was significantly higher than that of the standard thrombolysis group (64% vs. 36%; P=0.011). The sustained complete recanalization rate (40%vs. 8%; P=0.018) and complete recanalization rate (48% vs. 12%; P=0.012) of the ultrasound-enhanced thrombolysis group were significantly higher than those of the standard thrombolysis group, but there were no significant differences in the reocclusion rate (8% vs. 12%; P=0.637), incidence of symptomatic intracerebral hemorrhage (4% vs. 4%; P=1.000), and mortality (4% vs. 4%; P=1.000) compared with the standard thrombolysis group. Conclusions Ultrasound-enhanced thrombolysis can improve the sustained complete recanalization rate, complete recanalization rate, and good outcome rate after using rtPA within 2 h, and it does not increase the risks of symptomatic cerebral hemorrhage and death. It is a safe and effective adjunctive thrombolytic therapy. Key words: Stroke; Brain Ischemia; Thrombolytic Therapy; Tissue Plasminogen Activator; Ultrasonic Therapy; Ultrasonography, Doppler, Transcranial; Treatment Outcome