Who benefits from percutaneous closure of patent foramen ovale vs medical therapy for stroke prevention? In-depth and updated meta-analysis of randomized trials.

Who benefits from percutaneous closure of patent foramen ovale vs medical therapy for stroke prevention? In-depth and updated meta-analysis of randomized trials. World J Cardiol. 2019 Apr 26;11(4):126-136 Authors: Dahal K, Yousuf A, Watti H, Liang B, Sharma S, Rijal J, Katikaneni P, Modi K, Tandon N, Azrin M, Lee J Abstract BACKGROUND: A few randomized clinical trials (RCT) and their meta-analyses have found patent foramen ovale closure (PFOC) to be beneficial in prevention of stroke compared to medical therapy. Whether the benefit is extended across all groups of patients remains unclear. AIM: To evaluate the efficacy and safety of PFOC vs medical therapy in different groups of patients presenting with stroke, we performed this meta-analysis of RCTs. METHODS: Electronic search of PubMed, EMBASE, Cochrane Central, CINAHL and ProQuest Central and manual search were performed from inception through September 2018 for RCTs. Ischemic stroke (IS), transient ischemic attack (TIA), a composite of IS, TIA and systemic embolism (SE), mortality, major bleeding, atrial fibrillation (AF) and procedural complications were the major outcomes. Random-effects model was used to perform analyses. RESULTS: Meta-analysis of 6 RCTs including 3560 patients showed that the PFOC, compared to medical therapy reduced the risk of IS [odds ratio: 0.34; 95% confidence interval: 0.15-0.78; P = 0.01] and the composite of IS, TIA and SE [0.55 (0.32-0.93); P = 0.02] and i...
Source: World Journal of Cardiology - Category: Cardiology Authors: Tags: World J Cardiol Source Type: research

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Conclusions With the addition of anticoagulants, the benefit of PFO closure decreased gradually. Patient groups that adopt individualized medical therapy strategies may benefit more.
Source: Medicine - Category: Internal Medicine Tags: Research Article: Systematic Review and Meta-Analysis Source Type: research
Abstract Cardiogenic stroke (CS), characteristic causes of which include atrial fibrillation (AF) and right-to-left shunting due to a patent foramen ovale (PFO), has a well-known tendency to be associated with a more extensive ischemic area. This may result in severe neurological damage, and require strict life-long antithrombotic therapy. However, the fact that some patients have problems complying with the requirement for extended oral antithrombotic treatment has motivated the development of alternative approaches for stroke prevention. Heart structures such as the left atrial appendage (LAA) and PFO are potent...
Source: Journal of Cardiology - Category: Cardiology Authors: Tags: J Cardiol Source Type: research
Background: The efficacy of patent foramen ovale (PFO) closure remains controversial, and it is unclear which patient groups are best benefited. We performed this meta-analysis to clarify the efficacy of PFO closure of younger patients for prevention of recurrent ischemic neurological events. Methods: We systematically searched for studies of PFO closure for younger patients under the age of 55, and pooled available data on PFO closure of younger vs older patients and on PFO closure of younger patients vs medical therapy. The primary endpoints were the composite outcome of recurrent ischemic neurological events [strok...
Source: Medicine - Category: Internal Medicine Tags: Research Article: Systematic Review and Meta-Analysis Source Type: research
Authors: Campbell BC Abstract In recent years, reperfusion therapies such as intravenous thrombolysis and endovascular thrombectomy for ischaemic stroke have dramatically reduced disability and revolutionised stroke management. Thrombolysis with alteplase is effective when administered to patients with potentially disabling stroke, who are not at high risk of bleeding, within 4.5 hours of the time the patient was last known to be well. Emerging evidence suggests that other thrombolytics such as tenecteplase may be even more effective. Treatment may be possible beyond 4.5 hours in patients selected using brain imagi...
Source: Medical Journal of Australia - Category: General Medicine Tags: Med J Aust Source Type: research
Conclusion: PFO closure, as compared with medical therapy, was associated with decreased risk of recurrent stroke and increased risk of atrial fibrillation in cryptogenic stroke patients with PFO.
Source: Medicine - Category: Internal Medicine Tags: Research Article: Systematic Review and Meta-Analysis Source Type: research
Authors: Giacoppo D, Caronna N, Frangieh AH, Michel J, Andò G, Tarantini G, Kasel AM, Capodanno D, Byrne RA Abstract AIMS: Although three recent trials showed a significant stroke risk reduction after tPFOc, the impact on pooled evidence deserves attention and individual statistical power is limited. We aimed to pool available randomised clinical trials (RCT) to assess whether tPFOc is more effective and safe than antithrombotic therapy alone (ATA). METHODS AND RESULTS: Major electronic databases and tangential sources were searched and 6 trials (3560 patients) identified. At a median follow-up of 3.6 [2...
Source: EuroIntervention - Category: Cardiovascular & Thoracic Surgery Tags: EuroIntervention Source Type: research
This study was performed to evaluate the efficacy and safety of the device closure (DC) versus the medical therapy (MT) in patients with cryptogenic stroke or transient ischemic attack (TIA) and PFO.Summary: Randomized controlled trials with active and control groups receiving the DC plus MT and MT alone in patients with history of cryptogenic stroke/TIA and diagnosis of PFO were systematically searched. The main efficacy outcome was stroke recurrence. Subgroup-analyses were performed according to age, shunt size, and presence of atrial septal aneurysm (ASA). Safety endpoints included any serious adverse event (SAE), atria...
Source: Cerebrovascular Diseases - Category: Neurology Source Type: research
AbstractBackgroundWe performed an updated meta-analysis of all randomized-controlled trials (RCTs) comparing patent foramen ovale (PFO) closure with medical therapy for prevention of recurrent ischemic stroke.Methods and resultsWe searched Medline, EMBASE, and Cochrane databases, and proceedings of international meetings for RCTs of patients with cryptogenic stroke and PFO comparing percutaneous PFO closure versus medical therapy for prevention of recurrent ischemic stroke. The primary outcome was a composite ischemic/embolic endpoint comprising stroke, transient ischemic attack (TIA), peripheral embolism, and early death ...
Source: Clinical Research in Cardiology - Category: Cardiology Source Type: research
Abstract BACKGROUND: Cryptogenic strokes can be attributed to paradoxical emboli through patent foramen ovale (PFO). However, the effectiveness of PFO closure in preventing recurrent stroke is uncertain and the results of previous randomized clinical trials (RCTs) have been inconclusive. Hence, this study provides an updated meta-analysis of all RCTs comparing PFO closure with medical therapy for secondary prevention of cryptogenic stroke. METHODS: All RCTs were identified by a comprehensive literature search of PubMed, Embase, the Cochrane Collaboration Central Register of Controlled Trials, Scopus, and Clin...
Source: Cardiology Journal - Category: Cardiology Authors: Tags: Cardiol J Source Type: research
Abstract BACKGROUND: Previous randomized controlled trials (RCT) failed to demonstrate benefits of patent foramen ovale (PFO) closure (PFO-C) over medical therapy (MT) for secondary prevention of cryptogenic ischemic stroke. Three recently published RCTs, however, turned out positive for PFO-C and warrant an updated meta-analysis. METHODS: Data from all available RCTs on PFO-C vs. MT for secondary prevention of cryptogenic ischemic stroke up until October 2017 were abstracted and analyzed in a comprehensive meta-analysis. Clinical efficacy outcomes were recurrent stroke, recurrent TIA, and their combination; ...
Source: Clin Med Res - Category: Research Authors: Tags: Clin Res Cardiol Source Type: research
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