Ultrasound-enhanced thrombolysis, or sonothrombolysis, was associated with increased odds of complete recanalization vs intravenous thrombolysis in patients with acute ischemic stroke (AIS) with large vessel occlusions (LVO), according to study results published in Stroke.
Prior research on the safety and efficacy of sonothrombolysis for improving the odds of recanalization and favorable functional outcomes in patients with AIS with LVO has produced conflicting results. A previous large phase 3 randomized controlled clinical trial (RCT) on the safety of efficacy sonothrombolysis compared with intravenous tissue-type plasminogen activator found the delivery of sonothrombolysis was safe but it did not show additional clinical benefit in this patient group. The current study authors sought to analyze individual patient data from RCTs to systematically assess the safety and efficacy of sonothrombolysis with or without the addition of microspheres (small, particle spherical particles) in patients with AIS with LVO.
The study was a meta-analysis of 7 RCTs with a pooled cohort of 102 patients with AIS and LVO. The studies included in the analysis compared sonothrombolysis (n=138) with or without the addition of microspheres with intravenous thrombolysis alone (n=134). The researchers involved in the meta-analysis evaluated and compared these groups in terms of the rate of complete recanalization at 1 to 36 hours after initiation of assigned therapy.
Patients in the sonothrombolysis and intravenous thrombolysis alone groups had a median age of 68 and 67 years, respectively. A higher proportion of patients in the sonothrombolysis group was made up of men (66% vs 51%; P =.011).
Patients who received sonothrombolysis had higher odds of complete recanalization vs those assigned to intravenous thrombolysis alone (40.3% vs 22.4%, respectively; adjusted odds ratio [OR], 2.33; 95% CI, 1.02–5.34). In contrast, there was no significant difference between the 2 arms in terms of the likelihood of symptomatic intracranial hemorrhage (7.3% vs 3.7%; adjusted OR, 2.55; 95% CI, 0.76–8.52).
Additionally, there were no differences between the treatment groups in regard to the 3-month favorable functional outcome (adjusted OR, 1.43; 95% CI, 0.64–3.19) and 3-month functional independence (adjusted OR, 1.43; 95% CI, 0.77–2.64).
The researchers wrote that while there was a lack of heterogeneity between studies for all evaluated outcomes, significant differences were observed between trials in regard to outcome definitions, particularly for a complete recanalization and symptomatic intracranial hemorrhage.
Despite this limitation, the investigators wrote that their findings provide “preliminary evidence that sonothrombolysis nearly doubles the odds of complete recanalization when compared with intravenous thrombolysis alone in patients with AIS” and LVO.
Disclosure: Multiple authors declared affiliations with the pharmaceutical industry. Please refer to the original article for a full list of disclosures.
Tsivgoulis G, Katsanos AH, Eggers J, et al. Sonothrombolysis in patients with acute ischemic stroke with large vessel occlusion: An individual patient data meta-analysis. Stroke. Published online August 25, 2021. doi:10.1161/STROKEAHA.120.030960