Rahman Shah, MD; Mannu Nayyar, MD; Ion S. Jovin, MD, ScD; Abdul Rashid, MD; Beatrix R. Bondy, MD; Tai-Hwang M. Fan, MD, PhD; Michael P. Flaherty, MD, PhD; Sunil V. Rao, MD
Disclosures: Authors have disclosed no conflicts of interest. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M17-2679.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that her spouse has stock options/holdings with Targeted Diagnostics and Therapeutics. Darren B. Taichman, MD, PhD, Executive Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer and Johnson & Johnson.
Reproducible Research Statement:Study protocol: See Part 1 of the Supplement. Statistical code: See Methods. Data set: See tables, figures, and appendices.
Requests for Single Reprints: Rahman Shah, MD, University of Tennessee, School of Medicine, Division of Cardiovascular Diseases, Coleman College of Medicine Building, 956 Court Avenue, Suite A312, Memphis, TN 38163; e-mail, Shahcardiology@yahoo.com.
Current Author Addresses: Drs. Shah, Nayyar, Bondy, and Fan: University of Tennessee, Division of Cardiovascular Diseases, Coleman College of Medicine Building, 956 Court Avenue, Suite A312, Memphis, TN 38163.
Dr. Jovin: Virginia Commonwealth University, Department of Internal Medicine, PO Box 980509, Richmond, VA 23298.
Dr. Rashid: University of Tennessee, Jackson Clinic, 700 West Forest Avenue, Jackson, TN 38301.
Dr. Flaherty: University of Louisville, Rudd Heart & Lung Building, 201 Abraham Flexner Way, Suite 600, Louisville, KY 40292.
Dr. Rao: The Duke Clinical Research Institute, 2400 Pratt Street, Durham, NC 27705.
Author Contributions: Conception and design: R. Shah, M. Nayyar.
Analysis and interpretation of the data: R. Shah, M. Nayyar, I.S. Jovin, A. Rashid, B.R. Bondy, M.P. Flaherty, S.V. Rao.
Drafting of the article: R. Shah, M. Nayyar, A. Rashid.
Critical revision of the article for important intellectual content: R. Shah, M. Nayyar, I.S. Jovin, A. Rashid, B.R. Bondy, T.H.M. Fan, M.P. Flaherty, S.V. Rao.
Final approval of the article: R. Shah, M. Nayyar, I.S. Jovin, A. Rashid, B.R. Bondy, T.H.M. Fan, M.P. Flaherty, S.V. Rao.
Provision of study materials or patients: M. Nayyar.
Statistical expertise: R. Shah.
Administrative, technical, or logistic support: M. Nayyar.
Collection and assembly of data: R. Shah, M. Nayyar, A. Rashid, B.R. Bondy.
The optimal strategy for preventing recurrent stroke in patients with cryptogenic stroke and patent foramen ovale (PFO) is unknown.
To compare transcatheter PFO closure with medical therapy alone for prevention of recurrent stroke in patients with PFO and cryptogenic stroke.
PubMed and the Cochrane Library (without language restrictions) from inception to October 2017, reference lists, and abstracts from cardiology meetings.
Randomized trials enrolling adults with PFO and cryptogenic stroke that compared stroke outcomes (main outcome) and potential harms in those receiving transcatheter device closure versus medical therapy alone.
Two investigators independently extracted study data and rated risk of bias.
Of 5 trials, 1 was excluded because it used a device that is no longer available due to high rates of complications and failure. Four high-quality trials enrolling 2892 patients showed that PFO closure decreased the absolute risk for recurrent stroke by 3.2% (risk difference, −0.032 [95% CI, −0.050 to −0.014]) compared with medical therapy. The treatment strategies did not differ in rates of transient ischemic attack or major bleeding. Closure of PFOs was associated with higher rates of new-onset atrial fibrillation (AF) than medical therapy alone in all trials, but this outcome had marked between-trial heterogeneity (I2 = 82.5%), and high event rates in some groups resulted in extreme values for CIs.
Heterogeneity of device type and antithrombotic therapy across trials, small numbers for some outcomes, and heterogeneous and inconclusive AF results.
In patients with PFO and cryptogenic stroke, transcatheter device closure decreases risk for recurrent stroke compared with medical therapy alone. Because recurrent stroke rates are low even with medical therapy alone and PFO closure might affect AF risk, shared decision making is crucial for this treatment.
Shah R, Nayyar M, Jovin IS, Rashid A, Bondy BR, Fan TM, et al. Device Closure Versus Medical Therapy Alone for Patent Foramen Ovale in Patients With Cryptogenic Stroke: A Systematic Review and Meta-analysis. Ann Intern Med. 2018;168:335–342. doi: 10.7326/M17-2679
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Published: Ann Intern Med. 2018;168(5):335-342.
Published at www.annals.org on 9 January 2018
Cardiology, Neurology, Stroke.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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