Transcatheter patent foramen ovale closure versus medical therapy for cryptogenic stroke: a meta-analysis of randomized clinical trials

Persistent Link:
http://hdl.handle.net/10150/610353
Title:
Transcatheter patent foramen ovale closure versus medical therapy for cryptogenic stroke: a meta-analysis of randomized clinical trials
Author:
Riaz, Irbaz; Dhoble, Abhijeet; Mizyed, Ahmad; Hsu, Chiu-Hsieh; Husnain, Muhammad; Lee, Justin; Lotun, Kapildeo; Lee, Kwan
Affiliation:
Department of Internal Medicine, University of Arizona, Tucson, AZ 85714, USA; Department of Cardiovascular Diseases, University of Arizona, 3950 S Country Club Road, Suite 200, Tucson, AZ 85714, USA; Department of Biostatistics, University of Arizona, Tucson, AZ 85714, USA
Issue Date:
2013
Publisher:
BioMed Central
Citation:
Riaz et al. BMC Cardiovascular Disorders 2013, 13:116 http://www.biomedcentral.com/1471-2261/13/116
Journal:
BMC Cardiovascular Disorders
Rights:
© 2013 Riaz et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0)
Collection Information:
This item is part of the UA Faculty Publications collection. For more information this item or other items in the UA Campus Repository, contact the University of Arizona Libraries at repository@u.library.arizona.edu.
Abstract:
BACKGROUND:There is an association between cryptogenic stroke and patent foramen ovale (PFO). The optimal treatment strategy for secondary prevention remains unclear. The purpose of this study was to analyze aggregate data examining the safety and efficacy of transcatheter device closure versus standard medical therapy in patients with PFO and cryptogenic stroke.METHODS:A search of published data identified 3 randomized clinical trials for inclusion. The primary outcome was a composite end-point of death, stroke and transient-ischemic attack (TIA). Pre-defined subgroup analysis was performed with respect to baseline characteristics including age, sex, atrial septal aneurysm and shunt size. Data was synthesized using a random effects model and results presented as hazard ratios (HRs) with 95% confidence intervals (CIs).RESULTS:A cohort of 2,303 patients with a history of cryptogenic stroke and PFO were randomized to device closure (n=1150) and medical therapy (n=1153). Mean follow-up was 2.5years. Transcatheter closure was not superior to medical therapy in the secondary prevention of stroke or TIA in intention-to-treat analysis (HR: 0.66, 95% CI: 0.43 to 1.01; p=0.056). However, the results were statistically significant using per-protocol analysis (HR: 0.64, 95% CI: 0.41 to 0.98; p=0.043). Males had significant benefit with device closure (HR: 0.48, 95% CI: 0.24 to 0.96; p=0.038).CONCLUSIONS:In this meta-analysis, using intention-to-treat analysis, transcatheter device closure of PFO was not superior to standard medical therapy in the secondary prevention of cryptogenic stroke. Transcatheter closure was superior using per-protocol analysis.
EISSN:
1471-2261
DOI:
10.1186/1471-2261-13-116
Keywords:
Patent foramen ovale; Inter atrial shunt; Transcatheter closure; Cryptogenic stroke
Version:
Final published version
Additional Links:
http://www.biomedcentral.com/1471-2261/13/116

Full metadata record

DC FieldValue Language
dc.contributor.authorRiaz, Irbazen
dc.contributor.authorDhoble, Abhijeeten
dc.contributor.authorMizyed, Ahmaden
dc.contributor.authorHsu, Chiu-Hsiehen
dc.contributor.authorHusnain, Muhammaden
dc.contributor.authorLee, Justinen
dc.contributor.authorLotun, Kapildeoen
dc.contributor.authorLee, Kwanen
dc.date.accessioned2016-05-20T09:04:56Z-
dc.date.available2016-05-20T09:04:56Z-
dc.date.issued2013en
dc.identifier.citationRiaz et al. BMC Cardiovascular Disorders 2013, 13:116 http://www.biomedcentral.com/1471-2261/13/116en
dc.identifier.doi10.1186/1471-2261-13-116en
dc.identifier.urihttp://hdl.handle.net/10150/610353-
dc.description.abstractBACKGROUND:There is an association between cryptogenic stroke and patent foramen ovale (PFO). The optimal treatment strategy for secondary prevention remains unclear. The purpose of this study was to analyze aggregate data examining the safety and efficacy of transcatheter device closure versus standard medical therapy in patients with PFO and cryptogenic stroke.METHODS:A search of published data identified 3 randomized clinical trials for inclusion. The primary outcome was a composite end-point of death, stroke and transient-ischemic attack (TIA). Pre-defined subgroup analysis was performed with respect to baseline characteristics including age, sex, atrial septal aneurysm and shunt size. Data was synthesized using a random effects model and results presented as hazard ratios (HRs) with 95% confidence intervals (CIs).RESULTS:A cohort of 2,303 patients with a history of cryptogenic stroke and PFO were randomized to device closure (n=1150) and medical therapy (n=1153). Mean follow-up was 2.5years. Transcatheter closure was not superior to medical therapy in the secondary prevention of stroke or TIA in intention-to-treat analysis (HR: 0.66, 95% CI: 0.43 to 1.01en
dc.description.abstractp=0.056). However, the results were statistically significant using per-protocol analysis (HR: 0.64, 95% CI: 0.41 to 0.98en
dc.description.abstractp=0.043). Males had significant benefit with device closure (HR: 0.48, 95% CI: 0.24 to 0.96en
dc.description.abstractp=0.038).CONCLUSIONS:In this meta-analysis, using intention-to-treat analysis, transcatheter device closure of PFO was not superior to standard medical therapy in the secondary prevention of cryptogenic stroke. Transcatheter closure was superior using per-protocol analysis.en
dc.language.isoenen
dc.publisherBioMed Centralen
dc.relation.urlhttp://www.biomedcentral.com/1471-2261/13/116en
dc.rights© 2013 Riaz et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0)en
dc.subjectPatent foramen ovaleen
dc.subjectInter atrial shunten
dc.subjectTranscatheter closureen
dc.subjectCryptogenic strokeen
dc.titleTranscatheter patent foramen ovale closure versus medical therapy for cryptogenic stroke: a meta-analysis of randomized clinical trialsen
dc.typeArticleen
dc.identifier.eissn1471-2261en
dc.contributor.departmentDepartment of Internal Medicine, University of Arizona, Tucson, AZ 85714, USAen
dc.contributor.departmentDepartment of Cardiovascular Diseases, University of Arizona, 3950 S Country Club Road, Suite 200, Tucson, AZ 85714, USAen
dc.contributor.departmentDepartment of Biostatistics, University of Arizona, Tucson, AZ 85714, USAen
dc.identifier.journalBMC Cardiovascular Disordersen
dc.description.collectioninformationThis item is part of the UA Faculty Publications collection. For more information this item or other items in the UA Campus Repository, contact the University of Arizona Libraries at repository@u.library.arizona.edu.en
dc.eprint.versionFinal published versionen
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