Bernhard Reimers, Mirano Hospital, Italy, presented the results from a prospective, controlled, non-randomised, European multicentre trial to evaluate the performance of the Gore flow reversal system to protect the brain against embolization during carotid artery stenting.
Reimers explained that the Gore system provides proximal embolic protection by reversing the flow of blood through the ICA, directing embolic particles away from the brain.
According to Reimers, the study has enrolled 122 patients (91 men, 31 women) diagnosed with carotid stenosis (48 symptomatic, 74 asymptomatic) requiring revascularisation in 10 European centres. The primary endpoint was proportion of subjects experiencing one or more major adverse events (death, stroke) through 30-day follow-up. Results showed device success rate of 98% (119 patients). There was one technical access failure and two clinical failures due to intolerance to flow reversal. Carotid stenting was successful in all 122 patients. Two patients presented major adverse events: there was one (.8%) major stroke, post-procedure, and one (.8%) minor stroke, post-procedure. Thus, the primary endpoint of 30-day death and stroke rate was 1.6%. Myopcardial infarctions were not observed in this study.
Reimers concluded that the Gore Flow Reversal System is safe and efficacious for embolic protection during carotid angioplasty and stenting with a low incidence of intolerance rate. He added that the 30 days death/stroke rate is low and shows good outcome in both symptomatic (2.1%) and asymptomatic (1.4%) patients compared to American Heart Association guidelines for the treatment. “Flow reversal protection has the potential to reduce complications during carotid artery stenting,” Reimers said. “The presented data compare well with the recently presented data of the US EMPIRE study on the Gore flow reversal system in 250 patients (death and stroke rate 2.9%).”