SANTE trial of DBS for Epilepsy positive and published inNeurology- Medtronic

Medtronic plc has announced five-year results from the pivotal SANTE (Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy) trial, the largest clinical study of deep brain stimulation (DBS) therapy for epilepsy in adults with treatment-resistant (refractory) epilepsy characterized by partial-onset seizures. The results, which were recently published online by Neurology and will be printed in their March 2015 issue.

SANTE study results at five years include: 1.Medtronic DBS Therapy for Epilepsy was associated with a sustained and statistically significant reduction in seizure frequency from baseline that continued to improve over time: 69 percent median seizure reduction from baseline at five years and 41 percent at one year (p<0.001 for both time points). 2.The percentage of responders (patients with seizure reduction of 50 percent or greater) was 68 percent at five years and 43 percent at one year. 3.A seizure-free interval of at least six months during five years of therapy was reported by 16 percent of patients. 4.Statistically significant seizure severity and quality of life improvements were observed over baseline at five years and one year as measured by the Liverpool Seizure Severity Scale (LSSS) and Quality of Life measure (QOLIE-31) (p<0.001 for both measures).The most common serious adverse event through five years was implant site infection, with a rate of 10 percent. There were no device-related deaths and no unanticipated adverse device effects. Device-related implantation problems were reversible and as expected with this surgical procedure.

Comment:The 5-year SANTE data actually show an increase in efficacy over time. The median seizure reduction rate was 69% from baseline at 5 years, up from 41% at one year. The responder rate, based on a more than reduction in seizure frequency by more than half, was 68% at 5 years, up from 43%. Also, 16% of patients reported being seizure-free for at least 6 months.Overall, the study found that DBS stimulation results in reduced seizure frequency of 69%. However the trial had a 34% rate of serious, device-related adverse events at 5 years. The most common was implant site infection, which occurred at a rate of 10%. Device-related implantation problems were reversible and there were no device-related deaths.