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Systematic review of percutaneous closure versus medical therapy in patients with cryptogenic stroke and patent foramen ovale

OBJECTIVES: To provide a comprehensive comparison of patent foramen ovale (PFO) closure versus medical therapy in patients with cryptogenic stroke or transient ischaemic attack (TIA) and demonstrated PFO. DESIGN: Systematic review with complete case meta-analysis and sensitivity analyses. Data sourc...

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Autores principales: Spencer, Frederick A, Lopes, Luciane C, Kennedy, Sean A, Guyatt, Gordon
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3948581/
https://www.ncbi.nlm.nih.gov/pubmed/24607561
http://dx.doi.org/10.1136/bmjopen-2013-004282
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author Spencer, Frederick A
Lopes, Luciane C
Kennedy, Sean A
Guyatt, Gordon
author_facet Spencer, Frederick A
Lopes, Luciane C
Kennedy, Sean A
Guyatt, Gordon
author_sort Spencer, Frederick A
collection PubMed
description OBJECTIVES: To provide a comprehensive comparison of patent foramen ovale (PFO) closure versus medical therapy in patients with cryptogenic stroke or transient ischaemic attack (TIA) and demonstrated PFO. DESIGN: Systematic review with complete case meta-analysis and sensitivity analyses. Data sources included MEDLINE and EMBASE from 1980 up to May 2013. All randomised controlled trials (RCTs) comparing treatment with percutaneous catheter-based closure of PFO to anticoagulant or antiplatelet therapy in patients with cryptogenic stroke or TIA and echocardiographically confirmed PFO or atrial septal defect (ASD) were eligible. PARTICIPANTS: 1967 participants with prior stroke or TIA and echocardiographically confirmed PFO or ASD. PRIMARY OUTCOME MEASURES: The primary outcome of interest was recurrence of ischaemic stroke. We utilised data from complete cases only for the primary endpoint and combined data from trials to estimate the pooled risk ratio (RR) and associated 95% CIs calculated using random effects models. RESULTS: We identified 284 potentially eligible articles of which three RCTs including 2303 patients proved eligible and 1967 patients had complete data. Of the 1026 patients randomised to PFO closure and followed to study conclusion 22 experienced non-fatal ischaemic strokes, as did 34 of 941 patients randomised to medical therapy (risk ratio (RR) 0.61, 95% CI 0.34 to 1.07; heterogeneity: p=0.34, I(2)=8%, confidence in estimates low due to risk of bias and imprecision). Analyses for ischaemic stroke restricted to ‘per-protocol’ patients or patients with concomitant atrial septal aneurysm did not substantially change the observed RRs. Complication rates associated with either PFO closure or medical therapy were low. CONCLUSIONS: Pooled data from three RCTs provides insufficient support that PFO closure is preferable to medical therapy for secondary prevention of cryptogenic stroke in patients with PFO.
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spelling pubmed-39485812014-03-12 Systematic review of percutaneous closure versus medical therapy in patients with cryptogenic stroke and patent foramen ovale Spencer, Frederick A Lopes, Luciane C Kennedy, Sean A Guyatt, Gordon BMJ Open Cardiovascular Medicine OBJECTIVES: To provide a comprehensive comparison of patent foramen ovale (PFO) closure versus medical therapy in patients with cryptogenic stroke or transient ischaemic attack (TIA) and demonstrated PFO. DESIGN: Systematic review with complete case meta-analysis and sensitivity analyses. Data sources included MEDLINE and EMBASE from 1980 up to May 2013. All randomised controlled trials (RCTs) comparing treatment with percutaneous catheter-based closure of PFO to anticoagulant or antiplatelet therapy in patients with cryptogenic stroke or TIA and echocardiographically confirmed PFO or atrial septal defect (ASD) were eligible. PARTICIPANTS: 1967 participants with prior stroke or TIA and echocardiographically confirmed PFO or ASD. PRIMARY OUTCOME MEASURES: The primary outcome of interest was recurrence of ischaemic stroke. We utilised data from complete cases only for the primary endpoint and combined data from trials to estimate the pooled risk ratio (RR) and associated 95% CIs calculated using random effects models. RESULTS: We identified 284 potentially eligible articles of which three RCTs including 2303 patients proved eligible and 1967 patients had complete data. Of the 1026 patients randomised to PFO closure and followed to study conclusion 22 experienced non-fatal ischaemic strokes, as did 34 of 941 patients randomised to medical therapy (risk ratio (RR) 0.61, 95% CI 0.34 to 1.07; heterogeneity: p=0.34, I(2)=8%, confidence in estimates low due to risk of bias and imprecision). Analyses for ischaemic stroke restricted to ‘per-protocol’ patients or patients with concomitant atrial septal aneurysm did not substantially change the observed RRs. Complication rates associated with either PFO closure or medical therapy were low. CONCLUSIONS: Pooled data from three RCTs provides insufficient support that PFO closure is preferable to medical therapy for secondary prevention of cryptogenic stroke in patients with PFO. BMJ Publishing Group 2014-03-07 /pmc/articles/PMC3948581/ /pubmed/24607561 http://dx.doi.org/10.1136/bmjopen-2013-004282 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/
spellingShingle Cardiovascular Medicine
Spencer, Frederick A
Lopes, Luciane C
Kennedy, Sean A
Guyatt, Gordon
Systematic review of percutaneous closure versus medical therapy in patients with cryptogenic stroke and patent foramen ovale
title Systematic review of percutaneous closure versus medical therapy in patients with cryptogenic stroke and patent foramen ovale
title_full Systematic review of percutaneous closure versus medical therapy in patients with cryptogenic stroke and patent foramen ovale
title_fullStr Systematic review of percutaneous closure versus medical therapy in patients with cryptogenic stroke and patent foramen ovale
title_full_unstemmed Systematic review of percutaneous closure versus medical therapy in patients with cryptogenic stroke and patent foramen ovale
title_short Systematic review of percutaneous closure versus medical therapy in patients with cryptogenic stroke and patent foramen ovale
title_sort systematic review of percutaneous closure versus medical therapy in patients with cryptogenic stroke and patent foramen ovale
topic Cardiovascular Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3948581/
https://www.ncbi.nlm.nih.gov/pubmed/24607561
http://dx.doi.org/10.1136/bmjopen-2013-004282
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