Long-Term RESPECT Results Support PFO Closure With St. Jude Medical's Amplatzer Occluder in Patients With Previous Stroke

October 15, 2015—Long-term study results from the RESPECT trial found that closing a patent foramen ovale (PFO) with an Amplatzer PFO occluder (St. Jude Medical, Inc.) was superior to medical management in the prevention of recurrent cryptogenic stroke. The findings were reported at TCT 2015, the 27th annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation being held October 11–15 in San Francisco, California.

Lead investigator John D. Carroll, MD, commented in the TCT press release, “The long-term results of the RESPECT trial show that PFO closure is superior to medical management in reducing recurrent cryptogenic ischemic stroke. The procedure and device have proven to be safe.” Dr. Carroll is Professor of Medicine at the University of Colorado School of Medicine and Director of Interventional Cardiology at the University of Colorado Hospital in Denver, Colorado. 

The RESPECT study, which was sponsored by St. Jude Medical, enrolled 980 patients aged 18 to 60 years who were randomized to PFO closure (n = 499) or medical management (n = 481). Original enrollment ended when 25 ischemic stroke events occurred; the present report details longer-term follow-up from the trial, noted the TCT announcement.

The mean follow-up for the PFO group was 5.5 years and 4.9 years for the medical management group (total patient years: 2,769 [PFO] and 2,376 [medical management]). The overall intent-to-treat analysis showed no statistically significant difference in the incidence of all-cause strokes, which included both cryptogenic and other strokes (P = .16). When subsequent strokes were restricted to cryptogenic stroke, there was a 54% relative risk reduction in recurrent cryptogenic stroke for the PFO closure group (P = .042), although the absolute number of strokes remained small. 

An additional sensitivity analysis of all-cause stroke in patients under the age of 60 years (where a greater proportion of strokes are likely to be cryptogenic) showed a 52% relative risk reduction (P = .035). Additional benefit was also seen within a subgroup in two thirds of RESPECT patients who had PFO characteristics of substantial shunt or atrial septal aneurysm with a 75% reduction in cryptogenic stroke risk (P = .007).

Analysis of PFO closure procedure or device-related serious adverse events found no intraprocedure strokes, device embolization, device thrombosis, or device erosion. There was a low rate of major vascular complications (0.9%) and device explants (0.4%), reported the TCT announcement.