Landmark Study Finds Expensive Catheter Procedure to Close Hole in Heart No More Effective Than Medical Therapy to Prevent Strokes
HOUSTON, Tex -- February 28, 2017 -- After a decade of follow-up, the use of patent foramen ovale (PFO) closure device appears to reduce the risk of stroke recurrence significantly better than medical treatment alone, according to a study presented here at the 2017 International Stroke Conference (ISC).
In the final analysis of the Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT) study, of the 499 patients assigned to be implanted with the Amplatzer PFO Occluder, 18 stroke-related events occurred compared with 28 events among the 481 patients treated medically -- a relative risk reduction of 45% (P = .046).
“These analyses support the hypothesis that PFO closure is preventing PFO-related recurrent strokes,” reported David Thaler, MD, Tufts University School of Medicine, Boston, Massachusetts. “PFO closure cannot prevent strokes from non-PFO related causes.”
The final results of the Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT) awaited US Food and Drug Administration (FDA) regulatory decision. The data, which was first collected in 2003 was completed in 2015, was analysed by an FDA Advisory Panel in 2016. Dr. Thaler trial said the low rate of events required longer follow-up. The device was approved in Europe in 1998. The FDA approved the device in October 2016.
The researchers enrolled patients from 69 sites in the United States and Canada from 2003 to 2011. Patients who were believed to have PFO-related strokes were randomised between having the device implants and guideline-driven medical management. Patients were eligible if they experienced cryptogenic strokes within the last 9 months, were found to have a PFO, and were aged 18 to 60 years.
The composite endpoint was the occurrence of non-fatal ischaemic stroke, fatal ischaemic stroke or death within 45 days of randomisation. The definition of stroke for the study was neurological deficit due to cerebral ischaemia observed on imaging scans or stroke symptoms that lasted longer than 24 hours.
“In the RESPECT trial, PFO-closure with the Amplatzer PFO Occluder was more beneficial than medical management alone in the intention-to-treat population for the primary outcome,” Dr. Thaler concluded.
[Presentation title: PFO Closure Reduces Long Term Recurrence of Ischemic Stroke: Final Primary and Secondary Population Results From the RESPECT Multicenter Trial. Abstract 71]