Device closure versus medical therapy alone for patent foramen ovale in patients with cryptogenic stroke

A systematic review and meta-analysis

Rahman Shah, Mannu Nayyar, Ion S. Jovin, Abdul Rashid, Beatrix R. Bondy, Tai-Hwang Fan, Michael P. Flaherty, Sunil V. Rao

Research output: Contribution to journalReview article

25 Citations (Scopus)

Abstract

Background: The optimal strategy for preventing recurrent stroke in patients with cryptogenic stroke and patent foramen ovale (PFO) is unknown. Purpose: To compare transcatheter PFO closure with medical therapy alone for prevention of recurrent stroke in patients with PFO and cryptogenic stroke. Data Sources: PubMed and the Cochrane Library (without language restrictions) from inception to October 2017, reference lists, and abstracts from cardiology meetings. Study Selection: 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. Data Extraction: Two investigators independently extracted study data and rated risk of bias. Data Synthesis: 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 (I 2 = 82.5%), and high event rates in some groups resulted in extreme values for CIs. Limitation: Heterogeneity of device type and antithrombotic therapy across trials, small numbers for some outcomes, and heterogeneous and inconclusive AF results. Conclusion: 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.

Original languageEnglish (US)
Pages (from-to)335-342
Number of pages8
JournalAnnals of internal medicine
Volume168
Issue number5
DOIs
StatePublished - Mar 6 2018

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Patent Foramen Ovale
Meta-Analysis
Stroke
Equipment and Supplies
Atrial Fibrillation
Therapeutics
Information Storage and Retrieval
Transient Ischemic Attack
Cardiology
PubMed
Libraries
Decision Making
Language
Research Personnel
Hemorrhage

All Science Journal Classification (ASJC) codes

  • Internal Medicine

Cite this

Device closure versus medical therapy alone for patent foramen ovale in patients with cryptogenic stroke : A systematic review and meta-analysis. / Shah, Rahman; Nayyar, Mannu; Jovin, Ion S.; Rashid, Abdul; Bondy, Beatrix R.; Fan, Tai-Hwang; Flaherty, Michael P.; Rao, Sunil V.

In: Annals of internal medicine, Vol. 168, No. 5, 06.03.2018, p. 335-342.

Research output: Contribution to journalReview article

Shah, Rahman ; Nayyar, Mannu ; Jovin, Ion S. ; Rashid, Abdul ; Bondy, Beatrix R. ; Fan, Tai-Hwang ; Flaherty, Michael P. ; Rao, Sunil V. / Device closure versus medical therapy alone for patent foramen ovale in patients with cryptogenic stroke : A systematic review and meta-analysis. In: Annals of internal medicine. 2018 ; Vol. 168, No. 5. pp. 335-342.
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abstract = "Background: The optimal strategy for preventing recurrent stroke in patients with cryptogenic stroke and patent foramen ovale (PFO) is unknown. Purpose: To compare transcatheter PFO closure with medical therapy alone for prevention of recurrent stroke in patients with PFO and cryptogenic stroke. Data Sources: PubMed and the Cochrane Library (without language restrictions) from inception to October 2017, reference lists, and abstracts from cardiology meetings. Study Selection: 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. Data Extraction: Two investigators independently extracted study data and rated risk of bias. Data Synthesis: 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 (I 2 = 82.5{\%}), and high event rates in some groups resulted in extreme values for CIs. Limitation: Heterogeneity of device type and antithrombotic therapy across trials, small numbers for some outcomes, and heterogeneous and inconclusive AF results. Conclusion: 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.",
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AU - Rashid, Abdul

AU - Bondy, Beatrix R.

AU - Fan, Tai-Hwang

AU - Flaherty, Michael P.

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