Gore REDUCE Trial Evaluates Cardioform Device for PFO Closure
September 19, 2017—Lars Søndergaard, MD, et al published the findings from the Gore REDUCE Trial in The New England Journal of Medicine (NEJM;2017;377:1033–1042). The study evaluated the effect of patent foramen ovale (PFO) closure using the Cardioform septal occluder (Gore & Associates) combined with antiplatelet therapy versus antiplatelet therapy alone on the risks of recurrent stroke and new brain infarctions.
In May, Gore, which sponsored the trial, announced that the data were presented at ESOC 2017, the European Stroke Organization Conference in Prague, the Czech Republic. The company plans to submit the data to the US Food and Drug Administration to seek a PFO indication for the Cardioform device 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.
As summarized in NEJM, this multinational trial involved patients with a PFO who had had a cryptogenic stroke. Patients were randomly assigned in a 2:1 ratio to undergo PFO closure plus antiplatelet therapy (PFO closure group) or to receive antiplatelet therapy alone (antiplatelet-only group). Imaging of the brain was performed at the baseline screening and at 24 months.
The coprimary endpoints were freedom from clinical evidence of ischemic stroke (reported as the percentage of patients who had a recurrence of stroke) through at least 24 months after randomization and the 24-month incidence of new brain infarction, which was a composite of clinical ischemic stroke or silent brain infarction detected on imaging.
The investigators reported that they enrolled 664 patients (mean age, 45.2 years), of whom 81% had moderate or large interatrial shunts. During a median follow-up of 3.2 years, clinical ischemic stroke occurred in six of 441 patients (1.4%) in the PFO closure group, and in 12 of 223 patients (5.4%) in the antiplatelet-only group (hazard ratio, 0.23; 95% confidence interval, 0.09 to 0.62; P = .002).
The incidence of new brain infarctions was significantly lower in the PFO closure group than in the antiplatelet-only group (22 patients [5.7%] vs 20 patients [11.3%]; relative risk, 0.51; 95% confidence interval, 0.29 to 0.91; P = .04), but the incidence of silent brain infarction did not differ significantly between the study groups (P = .97). Serious adverse events occurred in 23.1% of the patients in the PFO closure group and in 27.8% of the patients in the antiplatelet-only group (P = .22). Serious device-related adverse events occurred in six patients (1.4%) in the PFO closure group, and atrial fibrillation occurred in 29 patients (6.6%) after PFO closure.
Among patients with a PFO who had had a cryptogenic stroke, the risk of subsequent ischemic stroke was lower among those assigned to PFO closure combined with antiplatelet therapy than among those assigned to antiplatelet therapy alone. However, PFO closure was associated with higher rates of device complications and atrial fibrillation, concluded the REDUCE investigators in NEJM.