The long-term study results from the RESPECT trial found that closing a patent foramen ovale (PFO) with an Amplatzer PFO Occluder was superior to medical management in the prevention of recurrent cryptogenic stroke in patients who previously had a cryptogenic stroke. The results were presented at the 2015 Transcatheter Cardiovascular Therapeutics (TCT) meeting (11–15 October, San Francisco, USA).
The RESPECT study examined the use of the Amplatzer PFO Occluder. A total of 980 patients between 18 and 60 years of age were randomised to PFO Closure (N=499) or medical management (N=481). Original enrolment ended when 25 ischaemic stroke events occurred; the present report details longer term follow-up from the trial.
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=0.16). 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=0.042), although the absolute number of strokes remained small. An additional sensitivity analysis of all-cause stroke in patients under the age of 60 (where a greater proportion of strokes are likely to be cryptogenic) showed a 52% relative risk reduction (p=0.035). Additional benefit was also seen within a subgroup in 2/3 of RESPECT patients who had PFO characteristics of substantial shunt or atrial septal aneurysm with a 75% reduction in cryptogenic stroke risk (p=0.007).
Analysis of PFO Closure procedure or device-related serious adverse events found no intra-procedure strokes, device embolization, device thrombosis or device erosion. There was a low rate of major vascular complications (0.9%) and device explants (0.4%).
Lead investigator John D Carroll (professor of Medicine at the University of Colorado School of Medicine and Director, Interventional Cardiology at the University of Colorado Hospital in Denver, USA), says: “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.”