scholarly journals The Efficacy of Percutaneous Patent Foramen Ovale Closure on Migraine: a Meta-Analysis of Randomized Controlled Trials and Observational Studies

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Quan-Quan Zhang ◽  
Jia-Jie Lu ◽  
Man-Yun Yan ◽  
Xiao-Wei Hu ◽  
Yi-Ren Qin ◽  
...  

Objectives. Whether patent foramen ovale (PFO) closure is effective on migraine is controversial. This article was aimed at assessing the efficacy of PFO closure on migraine based on randomized controlled trials (RCTs) and observational studies. Methods. We searched PubMed, Embase, and Cochrane databases up to October 2020 evaluating PFO closure versus control in patients with migraine, then conducted a meta-analysis of all RCTs and observational studies, respectively. The main outcomes were (1) respond rate: complete cessation of migraine; (2) reduction in the frequency of migraine attacks per month; and (3) reduction in migraine days per month. Results. Seven studies (3 RCTs and 4 observational studies), containing 887 migraine patients, were identified. (1) The respond rate of PFO closure on migraine was significantly higher than control group both in RCT subgroup and observational studies subgroup (OR 3.86, 95% CI 1.35-11.04, P = 0.01 in RCTs; OR 8.28, 95% CI 2.31-29.67, P = 0.001 in observational studies). (2) Reduction in frequency of migraine attacks was higher in PFO closure group compared with control group in the RCT subgroup analysis ( mean   difference   MD = 0.57 , 95% CI 0.23-0.90, P = 0.0009 ). (3) Reduction in migraine days was also higher in PFO closure group compared with control group in the RCT subgroup analysis ( MD = 1.33 , 95% CI 0.35-2.31, P = 0.008 ). Conclusions. PFO closure might be suitable for migraine patients, especially for migraine with aura, by cessation of migraine headaches or reducing migraine attacks and migraine days.

Cardiology ◽  
2019 ◽  
Vol 144 (1-2) ◽  
pp. 40-49 ◽  
Author(s):  
Aakash Garg ◽  
Mohammed Thawabi ◽  
Amit Rout ◽  
Chris Sossou ◽  
Marc Cohen ◽  
...  

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.


Neurology ◽  
2018 ◽  
Vol 91 (1) ◽  
pp. e1-e7 ◽  
Author(s):  
Hamidreza Saber ◽  
Mohan Palla ◽  
Shaghayegh Kazemlou ◽  
Mahmoud R. Azarpazhooh ◽  
Navid Seraji-Bozorgzad ◽  
...  

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.


2018 ◽  
Vol 107 (9) ◽  
pp. 745-755 ◽  
Author(s):  
Volker Schulze ◽  
Yingfeng Lin ◽  
Athanasios Karathanos ◽  
Maximilian Brockmeyer ◽  
Tobias Zeus ◽  
...  

Stroke ◽  
2019 ◽  
Vol 50 (11) ◽  
pp. 3135-3140 ◽  
Author(s):  
Dimitrios Sagris ◽  
Georgios Georgiopoulos ◽  
Kalliopi Perlepe ◽  
Konstantinos Pateras ◽  
Eleni Korompoki ◽  
...  

Background and Purpose— It is unclear whether treatment with anticoagulants or antiplatelets is the optimal strategy in patients with stroke or transient ischemic attack of undetermined cause and patent foramen ovale that is not percutaneously closed. We aimed to perform a systematic review and meta-analysis of randomized controlled trials to compare anticoagulant or antiplatelet treatment in this population. Methods— We searched PubMed until July 16, 2019 for trials comparing anticoagulants and antiplatelet treatment in patients with stroke/transient ischemic attack and medically treated patent foramen ovale using the terms: “cryptogenic or embolic stroke of undetermined source” and “stroke or cerebrovascular accident or transient ischemic attack” and “patent foramen ovale or patent foramen ovale or paradoxical embolism” and “trial or study” and “antithrombotic or anticoagulant or antiplatelet.” The outcomes assessed were stroke recurrence, major bleeding, and the composite end point of stroke recurrence or major bleeding. We used 3 random-effects models: (1) a reference model based on the inverse variance method with the Sidik and Jonkman heterogeneity estimator; (2) a strict model, implementing the Hartung and Knapp method; and (3) a commonly used Bayesian model with a prior that assumes moderate to large between-study variance. Results— Among 112 articles identified in the literature search, 5 randomized controlled trials were included in the meta-analysis (1720 patients, mean follow-up 2.3±0.5 years). Stroke recurrence occurred at a rate of 1.73 per 100 patient-years in anticoagulant-assigned patients and 2.39 in antiplatelet-assigned patients (hazard ratio, 0.68; 95% CI, 0.32–1.48 for the Sidik and Jonkman estimator). Major bleeding occurred at a rate of 1.16 per 100 patient-years in anticoagulant-assigned patients and 0.68 in antiplatelet-assigned patients (hazard ratio, 1.61; 95% CI, 0.72–3.59 for the Sidik and Jonkman estimator). The composite outcome occurred in 52 anticoagulant-assigned and 54 antiplatelet-assigned patients (odds ratio, 1.05; 95% CI, 0.65–1.70 for the Sidik and Jonkman estimator). Conclusions— We cannot exclude a large reduction of stroke recurrence in anticoagulant-assigned patients compared with antiplatelet-assigned, without significant differences in major bleeding. An adequately powered randomized controlled trial of a non–vitamin K antagonist versus aspirin is warranted.


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