Patent foramen ovale (PFO) closure versus medical therapy for prevention of recurrent stroke in patients with prior cryptogenic stroke: A systematic review and meta-analysis of randomized controlled trials

2018 ◽  
Vol 92 (1) ◽  
pp. 165-173 ◽  
Author(s):  
Anthony K. Akobeng ◽  
Ibtihal Abdelgadir ◽  
Younes Boudjemline ◽  
Ziyad M. Hijazi
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Patent Foramen Ovale ◽  
Recurrent Stroke ◽  
Meta Analysis ◽  
Cryptogenic Stroke ◽  
Controlled Trials ◽  
Foramen Ovale ◽  
Randomized Controlled ◽  
Pfo Closure

scholarly journals Recurrent Stroke Reduction with Patent Foramen Ovale Closure versus Medical Therapy Based on Patent Foramen Ovale Characteristics: A Meta-Analysis of Randomized Controlled Trials

Cardiology ◽  
2019 ◽  
Vol 144 (1-2) ◽  
pp. 40-49 ◽  
Author(s):  
Aakash Garg ◽  
Mohammed Thawabi ◽  
Amit Rout ◽  
Chris Sossou ◽  
Marc Cohen ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Medical Therapy ◽  
Patent Foramen Ovale ◽  
Recurrent Stroke ◽  
Meta Analysis ◽  
Cryptogenic Stroke ◽  
Controlled Trials ◽  
Foramen Ovale ◽  
Randomized Controlled ◽  
Pfo Closure

Efficacy of patent foramen ovale (PFO) closure in patients with cryptogenic stroke remains a matter of debate. We performed a comprehensive meta-analysis of available randomized controlled trials (RCTs) to evaluate the efficacy and safety of PFO closure versus medical therapy (MT) based on PFO characteristics. Random-effects meta-analysis was conducted to estimate risk ratio (RR) with 95% confidence intervals (CI) for the primary end points of stroke. After systematic search, six RCTs (3,747 patients) with 1,889 patients randomized to PFO closure and 1,858 patients randomized to the MT group were included in the meta-analysis. Overall, PFO closure was associated with a significant reduction in recurrent stroke compared to MT [RR 0.41; 95% CI 0.20–0.83]. While there were no differences in mortality or major bleeding between the two groups, risk of newly diagnosed atrial fibrillation was higher in the PFO closure group compared to MT [RR 5.29; 95% CI 2.32–12.06]. Further, risk reduction in stroke with PFO closure was significant in patients with high-risk PFO characteristics [RR 0.37; 95% CI 0.16–0.87] but not in low-risk patients [RR 0.73; 95% CI 0.29–1.84]. In conclusion, among patients with cryptogenic stroke, PFO closure is associated with a significantly reduced risk of recurrent stroke compared to MT. Additionally, the benefit of PFO closure might be dependent on certain PFO characteristics.

Network meta-analysis of patent foramen ovale management strategies in cryptogenic stroke

Neurology ◽  
2018 ◽  
Vol 91 (1) ◽  
pp. e1-e7 ◽  
Author(s):  
Hamidreza Saber ◽  
Mohan Palla ◽  
Shaghayegh Kazemlou ◽  
Mahmoud R. Azarpazhooh ◽  
Navid Seraji-Bozorgzad ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Patent Foramen Ovale ◽  
Recurrent Stroke ◽  
Meta Analysis ◽  
Cryptogenic Stroke ◽  
Bleeding Complications ◽  
Controlled Trials ◽  
Foramen Ovale ◽  
Randomized Controlled ◽  
Pfo Closure

ObjectiveTo compare the outcomes of patent foramen ovale (PFO) closure vs antiplatelet agent (APA) vs oral anticoagulation therapy (OAT) for secondary prevention of stroke in patients with cryptogenic stroke, using direct and indirect evidence from existing randomized data.MethodsRelevant randomized controlled trials were identified by a systematic review. The efficacy outcome was stroke recurrence, and safety outcomes were atrial fibrillation and bleeding complications at the end of follow-up. Bayesian network meta-analysis was performed to calculate risk estimates and the rank probabilities using APA therapy as the reference.ResultsIn a network meta-analysis of 6 randomized controlled trials consisting of 3,497 patients (1,732 PFO closure, 1,252 APA, 513 OAT), PFO closure and OAT were associated with lower rates of recurrent stroke (odds ratio [OR] 0.30, 95% credibility interval [CrI] 0.17–0.49 and OR 0.42, 95% CrI 0.22–0.78, respectively) with equal efficacy of OR 0.70 (95% CrI 0.37–1.49). PFO closure had the highest top rank probability of atrial fibrillation and OAT had the highest risk of bleeding complications.ConclusionsThese findings suggest that closure and OAT may be equally effective in recurrent stroke prevention in patients with PFO. There is an increased risk of atrial fibrillation and bleeding with closure and OAT therapy, respectively. A randomized trial is needed to identify patients who would benefit most from each strategy.

scholarly journals Percutaneous Closure versus Medical Therapy Alone for Cryptogenic Stroke Patients with a Patent Foramen Ovale: Meta-Analysis of Randomized Controlled Trials

2014 ◽  
Vol 41 (4) ◽  
pp. 357-367 ◽  
Author(s):  
Christopher A. Pickett ◽  
Todd C. Villines ◽  
Michael A. Ferguson ◽  
Edward A. Hulten
Keyword(s):  
Randomized Controlled Trials ◽  
Medical Therapy ◽  
Meta Analysis ◽  
Cryptogenic Stroke ◽  
Controlled Trials ◽  
Number Needed To Treat ◽  
Foramen Ovale ◽  
Stroke Patients ◽  
Randomized Controlled ◽  
Pfo Closure

Of cryptogenic stroke patients younger than 55 years of age, up to 61% have had a patent foramen ovale (PFO). Observational studies have revealed reductions in recurrent neurologic events through PFO closure versus medical therapy, and randomized controlled trials have shown nonsignificant trends toward benefit. We systematically searched for randomized controlled trials of percutaneous PFO closure with medical therapy versus medical therapy alone in patients with cryptogenic stroke and performed a meta-analysis of treatment outcomes. The primary endpoint was combined death, stroke, and transient ischemic attack. We included 3 trials. Of 2,303 total patients, 1,150 underwent PFO closure and 1,153 received medical therapy (median follow-up period, 2.6 yr). The pooled incidence of the primary endpoint was 1.2 events per 100 patient-years in the closure group (95% confidence interval [CI], 0.2–2.3) and 1.8 in the therapy group (95% CI, 0.7–2.9) (P=0.32); the number needed to treat was 167 (range, 100–500). The corresponding pooled hazard ratio was 0.67 (95% CI, 0.44–1.01; P=0.054) in favor of closure. Closure was associated with an increased risk of atrial fibrillation: relative risk=3.51 (95% CI, 1.44–8.55; P=0.006). When stratified by device, use of the Amplatzer™ PFO Occluder resulted in significant stroke-prevention benefit over medical therapy alone: hazard ratio=0.44 (95% CI, 0.21–0.95; P=0.037). When compared with medical therapy alone, PFO closure with medical therapy showed a trend toward a decreased hazard of combined events, although the absolute event reduction was small and the number needed to treat was high.

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