SAN FRANCISCO – Extended follow-up data from the RESPECT trial suggests that compared with medical management, a patent foramen ovale (PFO) closure device significantly decreases recurrent cryptogenic ischemic stroke in patients with PFO who had a cryptogenic stroke in the last 270 days.
“[This study] really adds a comprehensive update in the optimal management of these patients in trying to prevent recurrence of their stroke,” study investigator John D. Carroll, MD, said at a press conference at the Transcatheter Cardiovascular Therapeutics 2015 meeting.
For the RESPECT trial, Carroll, of the University of Colorado School of Medicine in Aurora, CO, and colleagues enrolled 980 patients (aged 18 to60 years) with a PFO who experienced a cryptogenic stroke in the preceding 270 days. Patients were randomly assigned to receive either a PFO occluder (Amplatzer, AGA Medical, Golden Valley, MN; n=499) or guideline-directed medication (n=481).
According to Carroll, RESPECT represents the largest randomized trial on PFO closure ever conducted with the longest-term follow-up, with a mean of 5 years and a duration of more than 10 years.
Intent-to-treat analysis results revealed no significant difference in all-cause stroke between groups (P=.16). However, when strokes were restricted to cryptogenic strokes only, Carroll and colleagues reported a 54% relative risk reduction in the PFO occlusion arm (P=.042), although the number of these strokes remained small (10 vs 19).
Among patients under the age of 60 years, researchers found a 52% relative risk reduction in the PFO closure arm (P=.035).
Furthermore, a 75% relative risk reduction in cryptogenic stroke was observed among PFO closure patients who had PFO characteristics of substantial shunt or atrial septal aneurysm (P=.007).
In safety analysis, there were no cases of device erosion, embolization or thrombosis, and no intra-procedure strokes. Additionally, the rate of atrial fibrillation was not significantly different between groups, Carroll noted.
“Treatment [effect] is fully manifest in the types of strokes for which PFO closure is intended,” Carroll concluded. “The superiority is substantial and sustained, and the procedure and the device now have long-term data showing its safety.”
Dr. Carroll added that in patients with cryptogenic stroke who have recurrent strokes that are not PFO mediated, these findings stress that in the long-term follow-up of these patients. “There has to be attention to other modifications of stroke risk factors,” he said.
Disclosures: This study was funded by St. Jude Medical. Dr. Carroll received consulting fees as a member of the Steering Committee for the RESPECT trial from St. Jude Medical.
1. Carroll JD et al. Late-Breaking Trials and First Report Investigations IV. Presented at: 27th Annual Transcatheter Cardiovascular Therapeutics scientific symposium; October 10-15, 2015; San Francisco.