Final results from the RESPECT trial found that percutaneously closing a patent foramen ovale (PFO) using the Amplatzer PFO Occluder (St Jude Medical) was superior to medical management in the prevention of recurrent ischaemic stroke in patients who previously had a cryptogenic stroke.
Findings were reported by David E Thaler (chairman of the Department of Neurology, Tufts Medical Center and Tufts University School of Medicine, associate professor of Neurology, Tufts University School of Medicine and director of the Comprehensive Stroke Center at Tufts Medical Center, Boston, USA) at the 28th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium (29 October‒2 November, Washington, USA).
The US Food and Drug Administration (FDA) recently approved the device for recurrent stroke prevention in patients with a PFO and history of cryptogenic stroke on the basis of these data.
Current guidelines call for medical management with anticoagulants or antiplatelet drugs for patients with PFO following a cryptogenic stroke. The RESPECT study examined the use of a device that closes the hole percutaneously versus medical management. From 2003 to 2011, a total of 980 patients between 18 and 60 years of age were randomised to PFO closure (N=499) or medical management (N=481) at 69 sites in the United States and Canada. The newest study results further extended follow-up, analysing data from August 2003 through May 2016 for outcomes of recurrent ischaemic strokes and recurrent ischaemic strokes of unknown mechanism.
The mean follow-up for the PFO group was 6.3 years and 5.5 years for the medical management group [total patient years: 3,141 (PFO) and 2,669 (medical management)]. Key findings showed that in the intention-to-treat cohort, there was a 45% relative risk reduction [HR 0.55 (95% CI: 0.305, 0.999) Log-rank 2-sided P-value: 0.046] in recurrent ischaemic stroke for the PFO group and a 62% risk reduction [HR 0.38 (95% CI: 0.18, 0.79) Log-rank 2-sided P-value: 0.007] from recurrent ischaemic stroke of unknown mechanism. An additional sensitivity analysis of all-cause stroke in patients under age 60 showed a 58% relative risk reduction [HR 0.42 (95% CI: 0.21, 0.83) Log-rank 2-sided P-value=0.010).
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 intra-procedural strokes, device embolisation, device thrombosis or device erosion. Major vascular complications (0.9%) and device explants (0.4%) were also low.
“The long-term results of the RESPECT trial show that PFO closure was more beneficial than medical management alone in reducing recurrent stroke,” said Thaler. “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.”