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©The Author(s) 2019. Published by Baishideng Publishing Group Inc. All rights reserved.
Who benefits from percutaneous closure of patent foramen ovale vs medical therapy for stroke prevention? In-depth and updated meta-analysis of randomized trials
Khagendra Dahal, Adil Yousuf, Hussam Watti, Brannen Liang, Sharan Sharma, Jharendra Rijal, Pavan Katikaneni, Kalgi Modi, Neeraj Tandon, Michael Azrin, Juyong Lee
Khagendra Dahal, Adil Yousuf, Hussam Watti, Pavan Katikaneni, Kalgi Modi, Division of Cardiology, Department of Medicine, Louisiana State University Health Sciences Center, Shreveport, LA 71103, United States
Brannen Liang, Department of Medicine, University of Connecticut Health Center, Farmington, CT 06030, United States
Sharan Sharma, Kansas City Heart Rhythm Institute, Overland Park, KS 66215, United States
Jharendra Rijal, Division of Cardiology, Hartford Medical Center, Hartford, CT 06102, United States
Neeraj Tandon, Cardiology Section, Overton Brooks VA Medical Center, Shreveport, LA 71101, United States
Michael Azrin, Juyong Lee, Division of Cardiology, University of Connecticut Health Center, Farmington, CT 06030, United States
Author contributions: Dahal K, Watti H and Lee J contributed to study concept and design; Dahal K, Yousuf A, Watti H, Liang B, Sharma, Rijal J, Katikaneni P, Modi K, Tandon N, Azrin M and Lee J contributed to acquisition, analysis, or interpretation of data; Dahal K, Yousuf A, Watti H and Liang B contributed to drafting of the manuscript; Dahal K, Yousuf A, Watti H, Liang B, Sharma S, Rijal J, Katikaneni P, Modi K, Tandon N, Azrin M and Lee J contributed to critical revision of the manuscript for important intellectual content; Dahal K contributed to statistical analysis; Modi K, Tandon N, Azrin M and Lee J contributed to study supervision.
Conflict-of-interest statement: None declared.
PRISMA 2009 Checklist statement: The authors have read the PRISMA 2009 Checklist, and the manuscript was prepared and revised according to the PRISMA 2009 Checklist.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) 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/4.0/
Corresponding author: Juyong Lee, MD, PhD, Division of Cardiology, University of Connecticut Health Center, Farmington, CT 06030, United States. jlee@uchc.edu
Telephone: +1-860-6793343
Received: January 8, 2019
Peer-review started: January 8, 2019
First decision: January 21, 2019
Revised: February 11, 2019
Accepted: March 27, 2019
Article in press: March 28, 2019
Published online: April 26, 2019
BACKGROUND
A few randomized clinical trials (RCT) and their meta-analyses have found patent foramen ovale closure (PFOC) to be beneficial in prevention of stroke compared to medical therapy. Whether the benefit is extended across all groups of patients remains unclear.
AIM
To evaluate the efficacy and safety of PFOC vs medical therapy in different groups of patients presenting with stroke, we performed this meta-analysis of RCTs.
METHODS
Electronic search of PubMed, EMBASE, Cochrane Central, CINAHL and ProQuest Central and manual search were performed from inception through September 2018 for RCTs. Ischemic stroke (IS), transient ischemic attack (TIA), a composite of IS, TIA and systemic embolism (SE), mortality, major bleeding, atrial fibrillation (AF) and procedural complications were the major outcomes. Random-effects model was used to perform analyses.
RESULTS
Meta-analysis of 6 RCTs including 3560 patients showed that the PFOC, compared to medical therapy reduced the risk of IS [odds ratio: 0.34; 95% confidence interval: 0.15-0.78; P = 0.01] and the composite of IS, TIA and SE [0.55 (0.32-0.93); P = 0.02] and increased the AF risk [4.79 (2.35-9.77); P < 0.0001]. No statistical difference was observed in the risk of TIA [0.86 (0.54-1.38); P = 0.54], mortality [0.74 (0.28-1.93); P = 0.53] and major bleeding [0.81 (0.42-1.56); P = 0.53] between two strategies. Subgroup analyses showed that compared to medical therapy, PFOC reduced the risk of stroke in persons who were males, ≤ 45 years of age and had large shunt or atrial septal aneurysm.
CONCLUSION
In certain groups of patients presenting with stroke, PFOC is beneficial in preventing future stroke compared to medical therapy.
Core tip: Closure of patent foramen ovale closure (PFOC) is a treatment modality for patients with stroke. To evaluate the efficacy and safety of PFOC vs medical therapy in different groups of patients presenting with stroke, we performed this meta-analysis of randomized trials following standard techniques. It showed that PFOC, compared to medical therapy reduced the risk of ischemic stroke and the composite outcome of stroke, transient ischemic attack (TIA) and systemic thromboembolism but no difference was observed in the risk of TIA, mortality and major bleeding. PFOC increased the risk of atrial fibrillation. Subgroup analyses showed that PFOC reduced the risk of stroke in males.
