Patent Foramen Ovale Closure or Antiplatelet Therapy for Cryptogenic Stroke
Top Cited Papers
- 14 September 2017
- journal article
- research article
- Published by Massachusetts Medical Society in The New England Journal of Medicine
- Vol. 377 (11), 1033-1042
- https://doi.org/10.1056/nejmoa1707404
Abstract
The efficacy of closure of a patent foramen ovale (PFO) in the prevention of recurrent stroke after cryptogenic stroke is uncertain. We investigated the effect of PFO closure combined with antiplatelet therapy versus antiplatelet therapy alone on the risks of recurrent stroke and new brain infarctions. In this multinational trial involving patients with a PFO who had had a cryptogenic stroke, we randomly assigned patients, 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 end points were freedom from clinical evidence of ischemic stroke (reported here 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. We 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 6 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 [CI], 0.09 to 0.62; P=0.002). 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% CI, 0.29 to 0.91; P=0.04), but the incidence of silent brain infarction did not differ significantly between the study groups (P=0.97). 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=0.22). Serious device-related adverse events occurred in 6 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. (Funded by W.L. Gore and Associates; Gore REDUCE ClinicalTrials.gov number, NCT00738894.)Keywords
This publication has 25 references indexed in Scilit:
- Practice advisory: Recurrent stroke with patent foramen ovale (update of practice parameter) [RETIRED]Neurology, 2016
- Device Closure of Patent Foramen Ovale After StrokeJournal of the American College of Cardiology, 2016
- Closure of Patent Foramen Ovale versus Medical Therapy after Cryptogenic StrokeThe New England Journal of Medicine, 2013
- Percutaneous Closure of Patent Foramen Ovale in Cryptogenic EmbolismThe New England Journal of Medicine, 2013
- Closure or Medical Therapy for Cryptogenic Stroke with Patent Foramen OvaleThe New England Journal of Medicine, 2012
- Silent Brain InfarctsStroke, 2011
- Transcatheter Closure versus Medical Therapy of Patent Foramen Ovale and Presumed Paradoxical ThromboemboliAnnals of Internal Medicine, 2003
- Validating the Questionnaire for Verifying Stroke-Free Status (QVSFS) by Neurological History and ExaminationStroke, 2001
- Interatrial septal abnormalities and strokeNeurology, 2000
- Paradoxical Embolism — Thrombus in Transit through a Patent Foramen OvaleThe New England Journal of Medicine, 1997