Evidence map›Paper›PMID 26916479›Full record

SynthesisJournal of the American College of Cardiology2016

Device Closure of Patent Foramen Ovale After Stroke: Pooled Analysis of Completed Randomized Trials.

David M Kent, Issa J Dahabreh, Robin Ruthazer, Anthony J Furlan, Mark Reisman, John D Carroll, Jeffrey L Saver, Richard W Smalling, Peter Jüni, Heinrich P Mattle and 2 more

Open access · greenAbstract readMeta-AnalysisReview
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Journal of the American College of Cardiology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 77 papers, 15 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
77citing papers in PubMed, 15 pooled it
36.9field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

77 citing papers in PubMed, 15 syntheses or guidelines pooled it, 203 citations in OpenAlex.

  1. Patent foramen ovale closure versus medical therapy alone in elderly patients with cryptogenic stroke: a systematic review and meta-analysis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026
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17 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 7 institutions in 3 countries.

David M KentPredictive Analytics and Comparative Effectiveness (PACE) Center, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center/Tufts University School of Medicine, Boston, Massachusetts; Department of Neurology, Tufts Medical Center/Tufts University School of Medicine, Boston, Massachusetts. Electronic address: dkent1@tuftsmedicalcenter.org.
Issa J DahabrehPredictive Analytics and Comparative Effectiveness (PACE) Center, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center/Tufts University School of Medicine, Boston, Massachusetts; Center for Evidence-based Medicine, School of Public Health, Brown University, Providence, Rhode Island; Department of Health Services, Policy & Practice, School of Public Health, Brown University, Providence, Rhode Island; Department of Epidemiology, School of Public Health, Brown University, Providence, Rhode Island.
Robin RuthazerPredictive Analytics and Comparative Effectiveness (PACE) Center, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center/Tufts University School of Medicine, Boston, Massachusetts.
Anthony J FurlanDepartment of Neurology, Case Western Reserve University, Cleveland, Ohio.
Mark ReismanDivision of Cardiology, University of Washington Medical Center, Seattle, Washington.
John D CarrollDivision of Cardiology, Department of Medicine, University of Colorado Denver, Aurora, Colorado.
Jeffrey L SaverComprehensive Stroke Center and Department of Neurology, David Geffen School of Medicine/University of California Los Angeles, Los Angeles, California.
Richard W SmallingDivision of Cardiology, Department of Medicine, The University of Texas Medical School at Houston, Houston, Texas.
Peter JüniInstitute of Primary Health Care and Clinical Trials Unit Bern, University of Bern, Switzerland; Applied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute of St. Michael's Hospital, University of Toronto, Ontario, Canada.
Heinrich P MattleDepartment of Neurology, Bern University Hospital, Bern, Switzerland.
Bernhard MeierDepartment of Cardiology, Bern University Hospital, Bern, Switzerland.
David E ThalerDepartment of Neurology, Tufts Medical Center/Tufts University School of Medicine, Boston, Massachusetts.
Tufts University · USUniversity Hospital of Bern · CHCase Western Reserve University · USUniversity of Bern · CHUniversity of California, Los Angeles · USUniversity of Colorado Denver · USUniversity of Washington Medical Center · US

Funding

The Risk of Paradoxical Embolism (ROPE) StudyR01NS062153 · NINDS · TUFTS MEDICAL CENTER · PI KENT, DAVID M · 2009 to 2012
$2.2M
Targeted Antithrombotic Therapy in Cryptogenic Stroke with Patent Foramen OvaleR21NS079826 · NINDS · TUFTS MEDICAL CENTER · PI KENT, DAVID M · 2012 to 2013
$430k
NINDS NIH HHS R01 NS062153NINDS NIH HHS R21 NS079826
6 · The paper itself

Abstract

backgroundThe comparative effectiveness of percutaneous closure of patent foramen ovale (PFO) plus medical therapy versus medical therapy alone for cryptogenic stroke is uncertain.

objectivesThe authors performed the first pooled analysis of individual participant data from completed randomized trials comparing PFO closure versus medical therapy in patients with cryptogenic stroke.

methodsThe analysis included data on 2 devices (STARFlex [umbrella occluder] [NMT Medical, Inc., Boston, Massachusetts] and Amplatzer PFO Occluder [disc occluder] [AGA Medical/St. Jude Medical, St. Paul, Minnesota]) evaluated in 3 trials. The primary composite outcome was stroke, transient ischemic attack, or death; the secondary outcome was stroke. We used log-rank tests and unadjusted and covariate-adjusted Cox regression models to compare device closure versus medical therapy.

resultsAmong 2,303 patients, closure was not significantly associated with the primary composite outcome. The difference became significant after covariate adjustment (hazard ratio [HR]: 0.68; p = 0.049). For the outcome of stroke, all comparisons were statistically significant, with unadjusted and adjusted HRs of 0.58 (p = 0.043) and 0.58 (p = 0.044), respectively. In analyses limited to the 2 disc occluder device trials, the effect of closure was not significant for the composite outcome, but was for the stroke outcome (unadjusted HR: 0.39; p = 0.013). Subgroup analyses did not identify significant heterogeneity of treatment effects. Atrial fibrillation was more common among closure patients.

conclusionsAmong patients with PFO and cryptogenic stroke, closure reduced recurrent stroke and had a statistically significant effect on the composite of stroke, transient ischemic attack, and death in adjusted but not unadjusted analyses.

Indexed as

Randomized Controlled Trials as TopicCardiac CatheterizationForamen Ovale, PatentHumansIncidenceProsthesis FailureSeptal Occluder DeviceStrokeSurvival RateUnited Statescryptogenic strokemeta-analysistransient ischemic attack

Identifiers

PMID26916479
PMCPMC4769377
OpenAlexW2274435192

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.