5-Year Results Published From REDUCE Study of PFO Closure With Gore’s Cardioform Septal Occluder

March 11, 2021—Gore & Associates announced long-term follow-up results from the Gore REDUCE study highlighting the benefits of patent foramen ovale (PFO) closure. The extended follow-up data support the use of the company’s Cardioform septal occluder in long-term recurrent stroke prevention, stated the company.

The data were published by Scott E. Kasner, MD, et al in The New England Journal of Medicine (2021;384:970-997).

As noted in the company’s announcement, the REDUCE study sought to determine the safety and efficacy of PFO closure with Gore’s Cardioform septal occluder or its Helex septal occluder plus antiplatelet medical management compared to antiplatelet medical management alone in patients with a PFO and history of cryptogenic stroke. The company advised that all PFO anatomies were incorporated into this study within indicated sizing parameters of the instructions for use.

According to Gore, the long-term data demonstrated a 69% relative reduction (P = .007) in ischemic stroke in patients treated with the Cardioform device compared to patients treated with antiplatelet therapy alone. There were no new device- or procedure-related serious adverse events observed during the extended follow-up (median of 5 years) and continue to build on the evidence of the Cardioform septal occluder’s safety.

The randomized-controlled, open-label study was composed of 664 patients enrolled 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 one new case of nonserious atrial fibrillation (AFib), and it resolved. At a median follow-up of 3.2 years, the study showed a 0.5% rate of device- or procedure-related serious AFib. At a median follow-up of 5 years, no new serious AFib cases were reported. No new cases of AFib were associated with the device or procedure, stated the company.

“We are excited to publish the REDUCE study extended follow-up,” commented John F. Rhodes, MD, in Gore’s press release. Dr. Rhodes, who serves as the United States Cardiology National Principal Investigator for the REDUCE study, continued. “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, embolization, 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.” Dr. Rhodes is from the Medical University of South Carolina in Charleston, South Carolina.

Gore noted that 25 patients would need to be treated with a Gore device to prevent one recurrent stroke event over 5 years, which demonstrates compelling real-world therapeutic value for patients treated with a Cardioform septal occluder.

The Cardioform septal occluder received FDA approval for the percutaneous closure of PFO in 2018. The device is also approved in the European Union for the percutaneous closure of PFO. It is also approved in the United States and European Union for the closure of a type of atrial septal defect, stated Gore & Associates.