Benefits of PFO Closure Confirmed in Publication of Trial Data

Friday, September 15, 2017

Recently published data in The New England Journal of Medicine from three different studies show that closing a patent foramen ovale (PFO) significantly reduces the rate of recurrent stroke compared with medical therapy in patients who experienced a cryptogenic stroke and had a PFO.

In the RESPECT study, the Amplatzer PFO Occluder (St. Jude Medical/Abbott Laboratories) was associated with a 45 percent reduction in the risk of ischemic stroke and a 62 percent reduction in the rate of cryptogenic stroke (NEJM; 2017;377:1022-1032). It was also associated with a strong safety profile, with a low risk of device- or procedure-related complications and no increased risk of adverse events, such as atrial fibrillation.

The REDUCE trial showed that patients undergoing PFO closure with Cardioform Septal Occluders (WL Gore and Associates) plus antiplatelet therapy experienced a significantly lower incidence of new brain infarctions as compared to patients receiving antiplatelet therapy only (1.4% vs 5.4%, respectively) at 3.2-year follow-up (NEJM; 2017;377:1033-1042). The incidence of silent brain infarction did not differ significantly between the study groups, however. Additionally, the authors noted that PFO closure was associated with higher rates of device complications and atrial fibrillation.

Finally, in the CLOSE trial, which evaluated PFO closure in patients who had had a recent cryptogenic stroke attributed to PFO with an associated atrial septal aneurysm or large interatrial shunt, investigators found that no strokes occurred in the PFO closure group more than five years after the procedure, whereas stroke occurred in 14 patients in the antiplatelet-only group (NEJM; 2017;377:1011-1021). Procedural complications were seen in 5.9% of patients in the PFO closure group. A higher rate of atrial fibrillation (4.6%) was also seen in the PFO group than the antiplatelet-only group.

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