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What are the outcomes of clinical trials conducted on EKOS System? This clinical overview presents all the completed and ongoing studies on Acoustic Pulse Thrombolysis.
In the Seattle II study of 150 patients with massive or acute intermediate-risk PE using an EKOS and lytic combination, the mean RV/LV ratio decreased from 1.55 pre-procedure to 1.13 at 48 hours post-procedure (p<0.0001) while PA systolic pressure decreased from 51.4 mm Hg to 36.9 mm Hg (p<0.0001). In contrast to the 2.5–3% rate of intracranial haemorrhaging associated with historical systemic fibrinolysis and full-dose tPA, no patients in this study experienced intracranial bleeding or fatal bleeding events.7
In the OPTALYSE PE study of 101 patients with submassive PE utilising EKOS therapy, each of the OPTALYSE 2, 4-hour and 6-hour cohorts reduced RV/LV ratio by 23-26%. Total tPA doses in the study ranged from 8mg-24mg bilaterally and the bleeding rate was a very low 3%. The one-year data demonstrated a 2% mortality rate - significantly below both anticoagulation and systemic therapy.16,17