Cryptogenic Stroke and High-Risk Patent Foramen Ovale: The DEFENSE-PFO Trial
Pil Hyung Lee, Jae-Kwan Song, Jong S Kim, Ran Heo, Sahmin Lee, Dae-Hee Kim, Jong-Min Song, Duk-Hyun Kang, Sun U Kwon, Dong-Wha Kang, Dongwhane Lee, Hyuk Sung Kwon, Sung-Cheol Yun, Byung Joo Sun, Jae-Hyeong Park, Jae-Hwan Lee, Hye Seon Jeong, Hee-Jung Song, Jei Kim, Seung-Jung Park, Pil Hyung Lee, Jae-Kwan Song, Jong S Kim, Ran Heo, Sahmin Lee, Dae-Hee Kim, Jong-Min Song, Duk-Hyun Kang, Sun U Kwon, Dong-Wha Kang, Dongwhane Lee, Hyuk Sung Kwon, Sung-Cheol Yun, Byung Joo Sun, Jae-Hyeong Park, Jae-Hwan Lee, Hye Seon Jeong, Hee-Jung Song, Jei Kim, Seung-Jung Park
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.
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.
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.
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).
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).
Keywords: cryptogenic stroke; echocardiography; patent foramen ovale.
Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed