Compared with medical therapy, PFO closure decreases the number of clinically apparent strokes

Reference

Messe SR, Erus G, Bilello M, et al, for the Gore REDUCE Study Investigators. Patent the foramen ovale closure decreases the incidence but not the size of new brain infarction on magnetic resonance imaging: an analysis of the REDUCE Trial. Stroke 2021;52(11):3419-3426.

Synopsis

These authors present data from the REDUCE trial in which 560 adults younger than 60 years with a patent foramen ovale (PFO) and a previous cryptogenic embolic stroke were randomized 2:1 to antiplatelet therapy plus PFO closure with the sponsor’s septal occluding device or to antiplatelet therapy alone. Although the participants and their caregivers were not masked, those interpreting the magnetic resonance imaging (MRIs) were masked to the intervention. In addition to a baseline MRI, after 2 years all study participants also had a follow-up MRI to look for new infarcts. Additionally, participants with stroke or transient ischemic attacks (TIAs) during follow-up also had MRIs. For this report, the authors eliminated the participants in each group who did not have a baseline and a follow-up MRI. During the 2 years of follow-up, suspected new stroke or TIA events occurred in 59 patients (15.4%) in the closure group and 46 patients (26.0%) in the control group. However, on masked review of the MRIs, new clinical strokes were reported in 5 patients (1.3%) assigned to closure and 12 patients (6.8%) assigned to medical treatment (number needed to treat = 19; 95% CI 10 - 47). The authors also report on a number of outcomes that are not relevant to primary care clinicians, such as stroke volume, number of infarcts, and distribution. They do not report on harms associated with each intervention.