Meta-analysis of Randomized Controlled Trials on Patent Foramen Ovale Closure Versus Medical Therapy for Secondary Prevention of Cryptogenic Stroke

Aiman Smer, Mohsin Salih, Toufik Mahfood Haddad, Raviteja Guddeti, Abdulghani Saadi, Alok Saurav, Ram Belbase, Mohamed Ayan, Mahmoud Traina, Venkata (Mahesh) Alla, Michael Del Core

Research output: Contribution to journalArticle

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Abstract

The optimal management of patients with cryptogenic stroke (CS) and patent foramen ovale (PFO) remains controversial. We conducted a meta-analysis to assess the effect of PFO closure for secondary prevention of stroke on patients with CS. We searched the literature for randomized control trials assessing the recurrence of stroke after PFO closure compared with medical therapy (antiplatelet and/or anticoagulation). Five randomized control trials with a total of 3,440 patients were included. The mean age was 45.2 ± 9.7 years and follow-up duration ranged from 2.0 to 5.9 years. PFO closure significantly reduced the risk of stroke compared with the medical therapy (2.8% vs 5.8%; relative risk [RR] 0.48, confidence interval [CI] 0.27 to 0.87, p = 0.01, I2 = 56%). The number needed to treat for stroke prevention was 10.5. PFO closure was associated with an increased risk of atrial fibrillation compared with medical therapy (4.2% vs 0.7%; RR 4.55, CI 2.16 to 9.6, p = 0.0001, I2 = 25%). There was no significant difference in all-cause mortality (RR 1.33, CI 0.56 to 3.16, p = 0.52, I2 = 0%), as well as no difference in bleeding risk between the 2 groups (RR 0.94, CI 0.49 to 1.83, p = 0.86, I2 = 29%). In conclusion, our meta-analysis demonstrates that PFO closure is associated with significantly lower risk of recurrent stroke in patients with PFO and CS compared with medical therapy. However, atrial fibrillation was more common among closure patients.

Original languageEnglish (US)
JournalAmerican Journal of Cardiology
DOIs
StateAccepted/In press - Jan 1 2018

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Patent Foramen Ovale
Secondary Prevention
Meta-Analysis
Randomized Controlled Trials
Stroke
Confidence Intervals
Therapeutics
Atrial Fibrillation
Numbers Needed To Treat
Hemorrhage
Recurrence
Mortality

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Meta-analysis of Randomized Controlled Trials on Patent Foramen Ovale Closure Versus Medical Therapy for Secondary Prevention of Cryptogenic Stroke. / Smer, Aiman; Salih, Mohsin; Mahfood Haddad, Toufik; Guddeti, Raviteja; Saadi, Abdulghani; Saurav, Alok; Belbase, Ram; Ayan, Mohamed; Traina, Mahmoud; Alla, Venkata (Mahesh); Del Core, Michael.

In: American Journal of Cardiology, 01.01.2018.

Research output: Contribution to journalArticle

Smer, Aiman ; Salih, Mohsin ; Mahfood Haddad, Toufik ; Guddeti, Raviteja ; Saadi, Abdulghani ; Saurav, Alok ; Belbase, Ram ; Ayan, Mohamed ; Traina, Mahmoud ; Alla, Venkata (Mahesh) ; Del Core, Michael. / Meta-analysis of Randomized Controlled Trials on Patent Foramen Ovale Closure Versus Medical Therapy for Secondary Prevention of Cryptogenic Stroke. In: American Journal of Cardiology. 2018.
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title = "Meta-analysis of Randomized Controlled Trials on Patent Foramen Ovale Closure Versus Medical Therapy for Secondary Prevention of Cryptogenic Stroke",
abstract = "The optimal management of patients with cryptogenic stroke (CS) and patent foramen ovale (PFO) remains controversial. We conducted a meta-analysis to assess the effect of PFO closure for secondary prevention of stroke on patients with CS. We searched the literature for randomized control trials assessing the recurrence of stroke after PFO closure compared with medical therapy (antiplatelet and/or anticoagulation). Five randomized control trials with a total of 3,440 patients were included. The mean age was 45.2 ± 9.7 years and follow-up duration ranged from 2.0 to 5.9 years. PFO closure significantly reduced the risk of stroke compared with the medical therapy (2.8{\%} vs 5.8{\%}; relative risk [RR] 0.48, confidence interval [CI] 0.27 to 0.87, p = 0.01, I2 = 56{\%}). The number needed to treat for stroke prevention was 10.5. PFO closure was associated with an increased risk of atrial fibrillation compared with medical therapy (4.2{\%} vs 0.7{\%}; RR 4.55, CI 2.16 to 9.6, p = 0.0001, I2 = 25{\%}). There was no significant difference in all-cause mortality (RR 1.33, CI 0.56 to 3.16, p = 0.52, I2 = 0{\%}), as well as no difference in bleeding risk between the 2 groups (RR 0.94, CI 0.49 to 1.83, p = 0.86, I2 = 29{\%}). In conclusion, our meta-analysis demonstrates that PFO closure is associated with significantly lower risk of recurrent stroke in patients with PFO and CS compared with medical therapy. However, atrial fibrillation was more common among closure patients.",
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AB - The optimal management of patients with cryptogenic stroke (CS) and patent foramen ovale (PFO) remains controversial. We conducted a meta-analysis to assess the effect of PFO closure for secondary prevention of stroke on patients with CS. We searched the literature for randomized control trials assessing the recurrence of stroke after PFO closure compared with medical therapy (antiplatelet and/or anticoagulation). Five randomized control trials with a total of 3,440 patients were included. The mean age was 45.2 ± 9.7 years and follow-up duration ranged from 2.0 to 5.9 years. PFO closure significantly reduced the risk of stroke compared with the medical therapy (2.8% vs 5.8%; relative risk [RR] 0.48, confidence interval [CI] 0.27 to 0.87, p = 0.01, I2 = 56%). The number needed to treat for stroke prevention was 10.5. PFO closure was associated with an increased risk of atrial fibrillation compared with medical therapy (4.2% vs 0.7%; RR 4.55, CI 2.16 to 9.6, p = 0.0001, I2 = 25%). There was no significant difference in all-cause mortality (RR 1.33, CI 0.56 to 3.16, p = 0.52, I2 = 0%), as well as no difference in bleeding risk between the 2 groups (RR 0.94, CI 0.49 to 1.83, p = 0.86, I2 = 29%). In conclusion, our meta-analysis demonstrates that PFO closure is associated with significantly lower risk of recurrent stroke in patients with PFO and CS compared with medical therapy. However, atrial fibrillation was more common among closure patients.

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