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Cryptogenic Stroke and High-Risk Patent Foramen Ovale: The DEFENSE-PFO Trial.
- Source :
-
Journal of the American College of Cardiology [J Am Coll Cardiol] 2018 May 22; Vol. 71 (20), pp. 2335-2342. Date of Electronic Publication: 2018 Mar 12. - Publication Year :
- 2018
-
Abstract
- Background: Recent reports showing the favorable role of patent foramen ovale (PFO) closure in patients with cryptogenic stroke have raised the issue of selecting optimal candidates.<br />Objectives: This study, DEFENSE-PFO (Device Closure Versus Medical Therapy for Cryptogenic Stroke Patients With High-Risk Patent Foramen Ovale), evaluated whether the benefits of PFO closure can be determined on the basis of the morphologic characteristics of the PFO, as evaluated by transesophageal echocardiography.<br />Methods: Patients with cryptogenic stroke and high-risk PFO were divided between a transcatheter PFO closure and a medication-only group. High-risk PFO included PFO with atrial septal aneurysm, hypermobility (phasic septal excursion into either atrium ≥10 mm), or PFO size (maximum separation of the septum primum from the secundum) ≥2 mm. The primary endpoint was a composite of stroke, vascular death, or Thrombolysis In Myocardial Infarction-defined major bleeding during 2 years of follow-up.<br />Results: From September 2011 until October 2017, 120 patients (mean age: 51.8 years) underwent randomization. PFO size, frequency of septal aneurysm (13.3% vs. 8.3%; p = 0.56), and hypermobility (45.0% vs. 46.7%; p > 0.99) were similar between the groups. All PFO closures were successful. The primary endpoint occurred exclusively in the medication-only group (6 of 60 patients; 2-year event rate: 12.9% [log-rank p = 0.013]; 2-year rate of ischemic stroke: 10.5% [p = 0.023]). The events in the medication-only group included ischemic stroke (n = 5), cerebral hemorrhage (n = 1), Thrombolysis In Myocardial Infarction-defined major bleeding (n = 2), and transient ischemic attack (n = 1). Nonfatal procedural complications included development of atrial fibrillation (n = 2), pericardial effusion (n = 1), and pseudoaneurysm (n = 1).<br />Conclusions: PFO closure in patients with high-risk PFO characteristics resulted in a lower rate of the primary endpoint as well as stroke recurrence. (Device Closure Versus Medical Therapy for Cryptogenic Stroke Patients With High-Risk Patent Foramen Ovale [DEFENSE-PFO]; NCT01550588).<br /> (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Adult
Aged
Cardiac Catheterization methods
Echocardiography, Transesophageal methods
Female
Follow-Up Studies
Foramen Ovale, Patent epidemiology
Humans
Male
Middle Aged
Risk Factors
Stroke epidemiology
Cardiac Catheterization trends
Fibrinolytic Agents administration & dosage
Foramen Ovale, Patent diagnostic imaging
Foramen Ovale, Patent therapy
Stroke diagnostic imaging
Stroke therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1558-3597
- Volume :
- 71
- Issue :
- 20
- Database :
- MEDLINE
- Journal :
- Journal of the American College of Cardiology
- Publication Type :
- Academic Journal
- Accession number :
- 29544871
- Full Text :
- https://doi.org/10.1016/j.jacc.2018.02.046