Closure versus Medical Therapy for Patent Foramen Ovale in Patients with Cryptogenic Stroke: An Updated Meta-Analysis of Randomized Controlled Trials

Qiu, Baoshan; Cai, Ying; Wang, Dilong; Lin, Jing; Fan, Yuhua

doi:10.1016/j.jstrokecerebrovasdis.2018.08.008

Cited by 6 publications

(9 citation statements)

References 20 publications

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“…We also confirmed that patients who underwent transcatheter closure were more likely to develop transient atrial fibrillation as compared with the medical-therapy group. Our findings are in line with the results of recent meta-analyses, [12][13][14][15][16][17][18][19] However, the present study includes data of the RESPECT trial published in 2013, as opposed to recent meta-analyses, which selected the RESPECT long-term results, published in 2017, and therefore are not the primary results of a controlled trial, but rather a follow-up study.…”

Section: Discussionsupporting

confidence: 89%

“…However, restricting device closure entirely to patients with high-risk characteristics of PFO may be too conservative. 11 Concerning the clinical trials currently published, several meta-analyses were carried out, [12][13][14][15][16][17][18][19] but all of them include data from a follow-up study 2 rather than the original clinical trial data, that is, data that the authors themselves considered to be exploratory.…”

Section: Original Articlementioning

confidence: 99%

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The Role of Patent Foramen Ovale Closure in the Secondary Prevention of Cryptogenic Stroke: a Meta-Analysis Report

Pereira

Nunes

Costa-Santos

et al. 2019

IJCS

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Background: Patent foramen ovale (PFO) closure has been compared to medical therapy for secondary prevention of recurrent cryptogenic stroke. Objectives: To produce an updated meta-analysis including only data from the primary analyses of clinical trials and to evaluate the role of PFO closure in the secondary prevention of recurrent stroke. Methods: Search in Medline (PubMed) and in ISI Web of Knowledge. Parameters under analysis and meta-analyses were: stroke, transient ischemic attack (TIA) and atrial fibrillation (AF). Comprehensive Meta-analysis Software V.2.0 (Biostat) was used. Random-effects analyses were carried out. A level of significance of 5% was used. Results: In this study six, randomized trials enrolling 3,750 patients were included. Unlike other published metaanalyses on the same topic, in this case, only clinical trial data, and not follow-up data, were used. PFO closure, as compared with medical therapy alone, demonstrated superiority in reducing the rate of recurrent stroke (risk ratio with PFO closure vs. medical therapy, 0.37; 95% confidence interval [CI], 0.17 to 0.78; p = 0.01). PFO closure did not offer a significant benefit in prevention of TIA (risk ratio with PFO closure vs. medical therapy, 0.96; 95% CI, 0.64 to 1.44; p = 0.85). Among patients assigned to closure group, an increased risk of atrial fibrillation was seen (risk ratio with PFO closure vs. medical therapy, 4.64; 95% CI, 2.38 to 9.01; p < 0.01). Conclusions: In patients with cryptogenic stroke who had a patent foramen ovale, a protective effect of closure was seen concerning the risk of recurrent stroke, but not regarding the prevention of TIA.

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Section: Discussionsupporting

confidence: 89%

Section: Original Articlementioning

confidence: 99%

The Role of Patent Foramen Ovale Closure in the Secondary Prevention of Cryptogenic Stroke: a Meta-Analysis Report

Pereira

Nunes

Costa-Santos

et al. 2019

IJCS

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“…The results of our meta-analysis are in concordance with the previously published reports. 20 , 21 , 22 , 23 , 24 , 25 , 26 …”

Section: Discussionmentioning

confidence: 99%

“…Although multiple meta-analyses on this topic have been published before, the previous analyses did not include the latest data from the DEFENSE-PFO trial. 20 , 21 , 22 , 23 , 24 , 25 , 26 In DEFENSE-PFO trial, the benefits of PFO closure were specifically evaluated on patients with cryptogenic stroke and high-risk PFO evaluated by transesophageal echocardiogram, which was not the case in other 3 favorable clinical trials. 15 DEFENSE-PFO trial provided further insight into the role of morphologic characteristics of PFO to select optimal candidates who can benefit most from PFO closure.…”

Section: Discussionmentioning

confidence: 99%

Patent foramen ovale closure versus medical therapy for cryptogenic stroke: An updated systematic review and meta-analysis

Goel

Patel

Zakin

et al. 2019

Indian Heart Journal

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Objectives The objective of this study was to compare safety and efficacy of patent foramen ovale (PFO) closure compared with medical therapy in patients with cryptogenic stroke (CS). Background The role of PFO closure in preventing recurrent stroke in patients with prior CS has been controversial. Methods We searched PubMed, EMBASE, the Cochrane Central Register of Controlled trials, and the clinical trial registry maintained at clinicaltrials.gov for randomized control trials that compared device closure with medical management and reported on subsequent stroke and adverse events. Event rates were compared using a forest plot of relative risk using a random-effects model assuming interstudy heterogeneity. Results A total of 6 studies ( n = 3747) were included in the final analysis. Mean follow-up ranged from 2 to 5.9 years. Pooled analysis revealed that device closure compared to medical management was associated with a significant reduction in stroke (risk ratio [RR] = 0.41, 95% CI = 0.20–0.83, I 2 = 51%, P = 0.01). There was, however, a significant increase in atrial fibrillation with device therapy (RR = 5.29, 95% CI = 2.32–12.06, I 2 = 38%, P < 0.0001). No effect was observed on major bleeding ( P = 0.50) or mortality ( P = 0.42) with device therapy. Subgroup analyses showed that device closure significantly reduced the incidence of the composite primary end point among patients who had large shunt sizes (RR = 0.35, 95% CI = 0.18–0.68, I 2 = 27%, P = 0.002). The presence/absence of atrial septal aneurysm ( P = 0.52) had no effect on the outcome. Conclusion PFO closure is associated with a significant reduction in the risk of stroke compared to medical management. However, it causes an increased risk of atrial fibrillation.

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“…However, the incidence of new onset supra-ventricular arrhythmia, mainly atrial fibrillation (AF) was significantly higher in the PFO closure group, suggesting that the procedure itself may induce AF. Recent meta -analysis confirmed a 4-fold increase of newly diagnosed AF after PFO closure compared with control [5] , [6] , [7] , [8] . Moreover, while randomized studies did not systematically assess occurrence of supra-ventricular arrhythmia after PFO closure, the incidence of this event after PFO closure may be underestimated.…”

Section: Introductionmentioning

confidence: 95%

Atrial fibrillation screening on systematic ambulatory electrocardiogram monitoring after percutaneous patent foramen ovale closure: A prospective study

Leclercq

Odorico

Marin

et al. 2021

IJC Heart & Vasculature

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Closure versus Medical Therapy for Patent Foramen Ovale in Patients with Cryptogenic Stroke: An Updated Meta-Analysis of Randomized Controlled Trials

Cited by 6 publications

References 20 publications

The Role of Patent Foramen Ovale Closure in the Secondary Prevention of Cryptogenic Stroke: a Meta-Analysis Report

The Role of Patent Foramen Ovale Closure in the Secondary Prevention of Cryptogenic Stroke: a Meta-Analysis Report

Patent foramen ovale closure versus medical therapy for cryptogenic stroke: An updated systematic review and meta-analysis

Atrial fibrillation screening on systematic ambulatory electrocardiogram monitoring after percutaneous patent foramen ovale closure: A prospective study

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