RESPECT Data Support St. Jude Medical's Amplatzer PFO Occluder to Prevent Recurrent Ischemic Stroke

November 1, 2016—Final results from the RESPECT trial found that percutaneous closure of a patent foramen ovale (PFO) using the Amplatzer PFO occluder device (St. Jude Medical, Inc.) was superior to medical management in the prevention of recurrent ischemic stroke in patients who previously had a cryptogenic stroke. Findings were presented as a First Report Investigation at TCT 2016, the 28th annual Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC.

The RESPECT study examined the use of the percutaneous Amplatzer PFO occluder versus medical management. The US Food and Drug Administration (FDA) recently approved the Amplatzer device for recurrent stroke prevention in patients with a PFO and history of cryptogenic stroke on the basis of these data.

As summarized in the TCT press release, the RESPECT study enrolled 980 patients between 18 and 60 years of age from 2003 to 2011. Patients were randomized to PFO closure (n = 499) or medical management (n = 481) at 69 sites in the United States and Canada. The mean follow-up for the PFO group was 6.3 years and 5.5 years for the medical management group; the total patient-years were 3,141 for PFO and 2,669 for medical management.

The newest study results further extended follow-up, analyzing data from August 2003 through May 2016 for outcomes of recurrent ischemic strokes and recurrent ischemic strokes of unknown mechanism.

In RESPECT, key findings showed that in the intention-to-treat cohort, there was a 45% relative risk reduction (hazard ratio [HR], 0.55; 95% confidence interval [CI], 0.305–0.999; log-rank two-sided P = .046) in recurrent ischemic stroke for the PFO group. There was a 62% risk reduction (HR, 0.38; 95% CI, 0.18–0.79; log-rank two-sided P = .007) from recurrent ischemic stroke of unknown mechanism. An additional sensitivity analysis of all-cause stroke in patients younger than 60 years showed a 58% relative risk reduction (HR, 0.42; 95% CI, 0.21–0.83; log-rank two-sided P = .01).

Technical success (delivery and release of the device) of the PFO closure was 99.1%, and procedural success (implantation without in-hospital serious adverse event) was 96.1%. In addition, there were no intraprocedural strokes, device embolization, device thrombosis, or device erosion. Major vascular complications (0.9%) and device explants (0.4%) were also low.

David E. Thaler, MD, commented in the TCT announcement, “The long-term results of the RESPECT trial show that PFO closure was more beneficial than medical management alone in reducing recurrent stroke. PFO closure can be considered an appropriate treatment option for patients with cryptogenic stroke to reduce their risk of recurrent stroke, but collaboration between a cardiologist and neurologist is important for proper patient selection.”