Results Presented From REDUCE Study of Gore's Cardioform for PFO Closure
May 16, 2017—Gore & Associates announced positive results from the company's REDUCE study assessing closure of patent foramen ovale (PFO) for the reduction of recurrent ischemic stroke and new brain infarct. The data were shared at the European Stroke Organization Conference in Prague, the Czech Republic.
Gore plans to submit the positive data to the US Food and Drug Administration (FDA) to seek a PFO indication for the Cardioform septal occluder by the end of 2017. In the United States, the Cardioform device is currently approved for the closure of atrial septal defects and is under investigation for the closure of PFOs.
Scott Kasner, MD, neurologist in the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, Pennsylvania, serves as the United States Neurology National Principal Investigator for the REDUCE Study.
In Gore's press release, Dr. Kasner commented, “The REDUCE data are groundbreaking for patients who have suffered a cryptogenic stroke attributed to a PFO. Until now, there has never been a study of a PFO closure device that showed statistically significant reduction in stroke recurrence in the primary intent-to-treat analysis. Other PFO closure device trials had to rely on secondary analysis, including following patients for up to a decade, before achieving statistical significance."
Dr. Kasner continued, "Also of note is the level of safety the Gore Cardioform septal occluder demonstrated, with no significant difference shown in the rate of serious adverse events between patients implanted with the device and those in the control arm. This trial demonstrates noteworthy verification that PFO closure with the Cardioform septal occluder is a valuable procedure to reduce recurrent stroke and brain infarct when utilized in an appropriate patient population.”
According to the company, the controlled, open-label REDUCE study assessed the safety and efficacy of PFO closure using Gore septal occluder devices in 664 randomized patients, aged 18 to 59 years with a history of cryptogenic stroke, across 63 investigational sites in seven countries. The trial met its primary endpoint by showing a statistically significant 76.6% reduction in recurrent ischemic stroke in patients who underwent PFO closure in conjunction with antiplatelet therapy versus those who underwent antiplatelet therapy alone after an average of 3.4 years follow-up (P = .001).
In addition to the primary endpoint of reduction of recurrent stroke, the study also met its co-primary endpoint of reduction of new brain infarct, inclusive of silent brain infarct (SBI), through PFO closure. Gore noted that an increased risk of clinical stroke, dementia, and cognitive dysfunction has been associated with SBI. This marks the first time a study assessed the relationship between PFO closure and the reduction of new brain infarct. Patients underwent baseline and 2-year follow-up MRI scans to determine if new brain infarct occurred. New brain infarct was present in 5.7% of test arm subjects and 11.3% of control arm subjects, yielding a 49.6% (P = .024) relative risk reduction for PFO closure on new brain infarct.
Gore additionally reported that the data showed no difference in the subject-based rate of serious adverse events between test and control groups. Device- and procedure-related serious adverse events occurred in 1.4% and 2.5%, respectively, of test patients. Patients experienced low rates of bleeding, deep vein thrombosis, and pulmonary embolism, with no significant difference between test and control groups. There was a significantly higher rate of serious atrial fibrillation in the test group (2.3% vs 0.4%) but the majority of atrial fibrillation was periprocedural (80% had onset within 30 days of the closure procedure) and had rapid resolution (70% with resolution within 2 days of onset).
The data from the REDUCE study suggestted that the risk of recurrent stroke can be dramatically reduced when the PFO is closed using Gore septal occluder devices, advised the company.