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PFO closure versus medical therapy for cryptogenic stroke: a meta-analysis of randomised controlled trials

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Title: PFO closure versus medical therapy for cryptogenic stroke: a meta-analysis of randomised controlled trials
Authors: Ahmad, Y
Howard, J
Arnold, A
Shun-Shin, MJ
Cook, C
Petraco, R
Demir, O
Williams, L
Igelsias, J
Sutaria, N
Malik, I
Davies, J
Mayet, J
Francis, D
Sen, S
Item Type: Journal Article
Abstract: Background The efficacy of patent foramen ovale (PFO) closure for cryptogenic stroke has been controversial. We undertook a meta-analysis of randomised controlled trials (RCTs) comparing device closure with medical therapy to prevent recurrent stroke for patients with PFO. Methods and Results We systematically identified all RCTs comparing device closure to medical therapy for cryptogenic stroke in patients with PFO. The primary efficacy endpoint was recurrent stroke, analysed on an intention-to-treat basis. The primary safety endpoint was new onset atrial fibrillation (AF). 5 studies (3440 patients) were included. 1829 patients were randomised to device closure and 1611 to medical therapy. Across all patients, PFO closure was superior to medical therapy for prevention of stroke (HR 0.32, 95% CI 0.13 to 0.82, p=0.018, I2 = 73.4%). The risk of AF was significantly increased with device closure (RR 4.54, 95% CI 2.17 to 9.48, p<0.001, heterogeneity I2 = 22.9%). In patients with large shunts, PFO closure was associated with a significant reduction in stroke (HR 0.33, 95% CI 0.16 to 0.72, p=0.005), whilst there was no significant reduction in stroke in patients with a small shunt (HR 0.90, 95% CI 0.50 to 1.60, p=0.712). There was no effect from the presence or absence of an atrial septal aneurysm on outcomes (p=0.994). Conclusion In selected patients with cryptogenic stroke, PFO closure is superior to medical therapy for the prevention of further stroke: this is particularly true for patients with moderate-to-large shunts. Guidelines should be updated to reflect this.
Issue Date: 7-May-2018
Date of Acceptance: 22-Feb-2018
URI: http://hdl.handle.net/10044/1/57475
DOI: https://dx.doi.org/10.1093/eurheartj/ehy121
ISSN: 1522-9645
Publisher: Oxford University Press (OUP)
Start Page: 1638
End Page: 1649
Journal / Book Title: European Heart Journal
Volume: 39
Issue: 18
Copyright Statement: © The Author(s) 2018. Published by Oxford University Press on behalf of the European Society of Cardiology. This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.or g/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re -use, please contact journals.permissions@oup.com
Sponsor/Funder: Wellcome Trust
Funder's Grant Number: PS3162_WHCP
Keywords: Science & Technology
Life Sciences & Biomedicine
Cardiac & Cardiovascular Systems
Cardiovascular System & Cardiology
Patent foramen ovale
1102 Cardiovascular Medicine And Haematology
Cardiovascular System & Hematology
Publication Status: Published
Open Access location: https://academic.oup.com/eurheartj/advance-article/doi/10.1093/eurheartj/ehy121/4944510
Online Publication Date: 2018-03-24
Appears in Collections:National Heart and Lung Institute