PFO closure reduces recurrent strokes – a therapeutic promise is finally kept
In patients with a patent foramen ovale (PFO) and cryptogenic stroke, percutaneous closure of the PFO has long been postulated to reduce the rate of recurrent strokes. However, up until now, trial data has failed to convincingly deliver a message of benefit for such an approach. Although the wait has been long, two recently reported trials finally seem to deliver on the therapeutic promise of PFO closure.
Reported from EuroPCR 2017, Paris
Originally presented at 3rd European Stroke Organisation Conference (ESOC) 2017, the CLOSE and the Gore-REDUCE trials concordantly reported a reduction in the rate of recurrent stroke in patients who had undergone PFO closure as compared to those who had not. In the CLOSE trial, 663 patients were randomly assigned to either PFO closure, oral anticoagulant therapy or antiplatelet therapy. The absolute risk reduction for recurrent stroke was 4.9% in the patients undergoing PFO closure at a mean of 5 years follow up. In the Gore-REDUCE trial, 664 subjects were randomised in a 2:1 ratio to either PFO closure or to antiplatelet therapy alone. The relative risk reduction for recurrent stroke was 76.6% (p=0.001) in patients that underwent PFO closure at a mean of 3.4 years follow up.
So why were these trials able to demonstrate a treatment benefit for PFO closure where previous studies had not? The answer to this question is likely due to the careful selection of patients that entered the trials. By selecting patients without concomitant coronary or embolic conditions, and in whom the PFO was associated with a moderate to large shunt or an atrial septal aneurysm (the latter being a feature of the CLOSE trial), the benefit of PFO closure was not masked by patient heterogeneity, a frequently cited criticism of previous trials.
CLOSE and Gore-REDUCE provide not only the long awaited evidence base for PFO closure in stroke prevention, they also inform a more tailored approach to optimal patient selection. In summary, 2017 marks an important year for the interventional treatment of stroke prevention and also the year where the therapeutic promise of PFO closure was finally kept.