Five-Year Outcomes of PFO Closure or Antiplatelet Therapy for Cryptogenic Stroke

Abstract

To the Editor: Closure of a patent foramen ovale (PFO) has been shown to reduce the risk of recurrent stroke in selected patients. 1 Data on outcomes of PFO closure in patients who were followed for a median of 5.9 years after the procedure are available; however, these data are limited to closure with a single device. 2 We have reported the results of the Gore REDUCE Clinical Study, 3 a prospective, randomized, open-label trial that compared the efficacy and safety of two closure devices plus antiplatelet agents (PFO closure group) with those of antiplatelet agents alone (antiplatelet-only group) for reducing the risk of recurrent ischemic stroke; the median duration of follow-up was 3.2 years, and outcome events were adjudicated in a blinded manner (the protocol is available with initial 2017 report 3). Here, we report the results of the planned 5-year outcome analysis.