Five-year follow-up results from the Gore REDUCE study, assessing the Gore Cardioform or Helex septal occluder versus antiplatelet therapy in long-term recurrent stroke prevention, have been published in the March 2021 issue of The New England Journal of Medicine (NEJM). The results highlight the benefits of patent foramen ovale (PFO) closure, Gore said in a press release.
The long-term data demonstrated a 69% relative reduction (p=0.007) in ischaemic stroke in patients treated with a Gore device compared to patients treated with antiplatelet therapy alone. Significantly, these data demonstrate no new device or procedure-related serious adverse events observed during the extended follow-up (median of five years).
The REDUCE study evaluated whether PFO closure with a Gore device plus antiplatelet therapy reduces the risk of stroke compared to antiplatelet therapy alone. The controlled, open-label study included 664 randomised patients at 63 investigational sites in seven countries. A total of 441 patients were treated with a Gore device for PFO closure plus antiplatelet therapy and 223 patients were treated with antiplatelet therapy alone.
During the extended follow-up, there was only one new case of non-serious atrial fibrillation (AF), and it resolved. At a median follow-up of 3.2 years the study showed only 0.5% device- or procedure-related serious AF, and at a median follow-up of five years, no new serious AF cases were reported. No new cases of AF were associated with the device or procedure.
“We are excited to publish the REDUCE study extended follow-up. These are important data as they confirm the procedure is safe with only one new episode of atrial fibrillation and no issues related to frame fractures, thrombus, embolisation or erosion. Overall, the benefit of PFO closure persisted during late follow-up by lowering the risk of recurrent stroke with minimal risk for adverse events,” said John F Rhodes, Medical University of South Carolina, Charleston, USA and US cardiology national principal investigator for the REDUCE study.
PFOs occur after birth when the foramen ovale, an opening between the heart’s upper two chambers in an unborn baby, fails to close and allows blood to flow between the two atria. PFO occurs in about one in four people. While most people do not need to be treated for PFO, in some patients, stroke can occur if a blood clot travels through the opening and to the brain. About one quarter of first-time strokes are cryptogenic, or due to an unknown cause, and up to half of patients who have a cryptogenic stroke are found to have PFO.
The Cardioform septal occluder comprises of a nitinol wire frame structure, covered with ePTFE material, conforms to the adjacent, native anatomy.
“These outcomes for long-term safety and recurrent stroke reduction speak volumes to the durability, performance and effectiveness of the Gore Cardioform septal occluder,” said John Laschinger, Gore’s cardiac chief medical advisor. “The unique benefit of our conformable design tailored to fit unique PFO anatomies is underscored by the fact that Gore Cardioform septal occluder has a 99% effective closure rate at 24 months.”
The Gore Cardioform septal occluder received US Food and Drug Administration (FDA) premarket approval for the percutaneous closure of PFO in 2018. It is also approved in the European Union for percutaneous closure of PFO. Furthermore, it is approved in the USA and European Union for closure of a type of atrial septal defect.