TCT 2016: PFO closure is more effective than medical management in preventing recurrent stroke

The final results from the RESPECT trial are in. According to researchers, percutaneously closing a patent foramen ovale (PFO) using the Amplatzer PFO Occluder was superior to medical management in the prevention of recurrent ischemic stroke in patients who previously had a cryptogenic stroke.

The findings were reported Nov. 1 at the 28th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.

From 2003 to 2011, a total of 980 subjects between 18 and 60 years of age were randomized to PFO closure or medical management at 69 sites in the United States and Canada. The newest study analyzed data from August 2003 through May 2016 for outcomes of recurrent ischemic strokes and recurrent ischemic 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. In the intention-to-treat cohort, there was a 45 percent relative risk reduction in recurrent ischemic stroke for the PFO group and a 62 percent risk reduction from recurrent ischemic stroke of an unkown mechanism. An additional sensitivity analysis of all-cause stroke in patients under age 60 showed a 58 percent relative risk reduction.

Technical success—delivery and release of the PFO device—was achieved 99.1 percent of the time. In a hospital setting, procedural success was achieved 96.1 percent of the time. There were no intra-procedural strokes, device embolization, device thrombosis or device erosion. Major vascular complications (0.9 percent) and device explants (0.4 percent) 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 David E. Thaler, MD, PhD, 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. "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."