Final results from Respect trial show St. Jude’s Amplatzer PFO Occluder superior to blood thinners
Treatment with the Amplatzer PFO Occluder made by St. Jude Medical (NYSE:STJ) is superior to medical management with anti-coagulant drugs in preventing recurrent ischemic strokes in patients with prior cryptogenic stroke, according to long-term final results from the Respect trial.
Last month the FDA approved the Amplatzer PFO Occluder based on the data from the 980-patient Respect trial, which posted a mean follow-up of 6.3 years for the PFO group and 5.5 years for the medical management group. There was a 45% relative risk reduction in recurrent ischemic stroke for the PFO group and a 62% risk reduction from recurrent ischemic stroke of unknown mechanism. The rate of all-cause stroke in patients under age 60 showed a 58% relative risk reduction.
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 embolizations, device thromboses or device erosions. 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,” principal investigator Dr. David Thaler, of the Tufts University School of Medicine, said in prepared remarks. “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.”
“The Respect trial generated more than 5,800 patient-years of data and an average 6 years of patient follow-up,” added St. Jude’s chief medical officer Dr. Mark Carlson. “These final long-term results are key, showing the treatment to be effective in preventing another stroke in PFO patients who are otherwise healthy.”