Patent foramen ovale closure appears to be superior to medical management in preventing the recurrence of cryptogenic stroke, according to extended follow-up results from the RESPECT trial presented at the annual TCT Scientific Symposium.
“We conclude, with this long-term, really extensive amount of new data, that treatment with the Amplatzer PFO Occluder is superior to guideline-recommended medical management,” John D. Carroll, MD, of the University of Colorado School of Medicine, said.
The findings presented were the longest ever from the RESPECT trial, which halted its original enrollment due to 25 ischemic events.
Carroll and colleagues evaluated 980 adults aged 18 to 60 years with PFO who had experienced cryptogenic stroke in the previous 270 days. Patients were randomly allocated to undergo treatment with the Amplatzer PFO Occluder (St. Jude Medical; n = 499) or guideline-directed medical management (n = 481).
The mean follow-up was 5.5 years for patients in the Amplatzer cohort and 4.9 years for those in the medical management group; this translated to 2,769 patient-years in the Amplatzer cohort and 2,376 patient-years in the medical management group. Trial duration was more than 10 years.
An analysis of the intention-to-treat patient population showed no significant differences in all-cause strokes between groups. In a subsequent analysis limited to cryptogenic strokes, patients demonstrated a 54% risk reduction in recurrence with Amplatzer vs. medical management (10 strokes vs. 19 strokes; HR = 0.46; log-rank P = .042).
An intention-to-treat sensitivity analysis among patients younger than 60 years showed a 52% risk reduction associated with Amplatzer (12 strokes in 475 patients) vs. medical management (22 strokes in 463 patients; HR = 0.476; log-rank P = .035).
Further, an atrial septal aneurysm/substantial shunt subgroup analysis in this population revealed an additional 75% cryptogenic stroke risk reduction with Amplatzer (four strokes in 319 patients) vs. medical management (13 strokes in 301 patients; HR = 0.245; log-rank P = .007).
No intraprocedural device embolization, device thrombosis or device erosion was observed in an analysis of PFO closure procedure or device-related serious adverse events; additionally, there was a low rate of major vascular complications (0.9%) and device explants (0.4%).
Carroll said this extended follow-up demonstrated the clear superiority of PFO closure over medical management.
“The treatment is fully manifest in the types of strokes for which PFO is intended,” he said. “The superiority is substantial and sustained, and the procedure and device now have long-term data showing their safety.” – by Jennifer Byrne
Carroll JD, et al. RESPECT Trial: Extended Follow-Up. Presented at: TCT Scientific Symposium; Oct. 11-15, 2015; San Francisco.
Carroll JD, et al. N Engl J Med. 2013;doi:10.1056/NEJMoa1301440.
Disclosures: Carroll reports receiving consulting fees as a member of the Steering Committee for the RESPECT trial from St. Jude Medical.