Evidence map›Paper›PMID 29500568›Full record

SynthesisClinical research in cardiology : official journal of the German Cardiac Society2018

Patent foramen ovale closure or medical therapy for cryptogenic ischemic stroke: an updated meta-analysis of randomized controlled trials.

Volker Schulze, Yingfeng Lin, Athanasios Karathanos, Maximilian Brockmeyer, Tobias Zeus, Amin Polzin, Stefan Perings, Malte Kelm, Georg Wolff

Abstract readMeta-AnalysisReview
PubMed Publisher
In one paragraph

Synthesis in Clinical research in cardiology : official journal of the German Cardiac Society, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. Interventional closure vs. medical therapy of patent foramen ovale for secondary prevention of stroke: updated meta-analysis.Clinical research in cardiology : official journal of the German Cardiac Society · 2019
    Pooled it
  2. Review
  3. Review
  4. Article
  5. Review
  6. Article
  7. Article
  8. Patent Foramen Ovale Closure: State of the Art.Interventional cardiology (London, England) · 2020
    Review
  9. Article
  10. Article
  11. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 1 institution in 1 country.

Volker SchulzeDepartment of Internal Medicine, Division of Cardiology, Pulmonology and Vascular Medicine, Heinrich-Heine-University, Moorenstr. 5, 40225, Düsseldorf, Germany.
Yingfeng LinDepartment of Internal Medicine, Division of Cardiology, Pulmonology and Vascular Medicine, Heinrich-Heine-University, Moorenstr. 5, 40225, Düsseldorf, Germany.
Athanasios KarathanosDepartment of Internal Medicine, Division of Cardiology, Pulmonology and Vascular Medicine, Heinrich-Heine-University, Moorenstr. 5, 40225, Düsseldorf, Germany.
Maximilian BrockmeyerDepartment of Internal Medicine, Division of Cardiology, Pulmonology and Vascular Medicine, Heinrich-Heine-University, Moorenstr. 5, 40225, Düsseldorf, Germany.
Tobias ZeusDepartment of Internal Medicine, Division of Cardiology, Pulmonology and Vascular Medicine, Heinrich-Heine-University, Moorenstr. 5, 40225, Düsseldorf, Germany.
Amin PolzinDepartment of Internal Medicine, Division of Cardiology, Pulmonology and Vascular Medicine, Heinrich-Heine-University, Moorenstr. 5, 40225, Düsseldorf, Germany.
Stefan PeringsDepartment of Internal Medicine, Division of Cardiology, Pulmonology and Vascular Medicine, Heinrich-Heine-University, Moorenstr. 5, 40225, Düsseldorf, Germany.
Malte KelmDepartment of Internal Medicine, Division of Cardiology, Pulmonology and Vascular Medicine, Heinrich-Heine-University, Moorenstr. 5, 40225, Düsseldorf, Germany.
Georg WolffDepartment of Internal Medicine, Division of Cardiology, Pulmonology and Vascular Medicine, Heinrich-Heine-University, Moorenstr. 5, 40225, Düsseldorf, Germany. georg.wolff@med.uni-duesseldorf.de.ORCID http://orcid.org/0000-0002-1734-6177
Heinrich Heine University Düsseldorf · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrevious 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.

methodsData 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; safety outcomes were mortality, major bleeding, venous thromboembolism (VTE), and new-onset atrial fibrillation/flutter (NOAF).

resultsFive trials including a total of 3440 patients were included in the meta-analysis. PFO-C significantly reduced recurrent stroke [odds ratio (OR) 0.41, 95% confidence interval (CI) 0.19-0.90; p = 0.03] and the combination of recurrent stroke + TIA (OR 0.53, CI 0.36-0.80; p = 0.002) compared to MT; recurrent TIA alone showed no differences (OR 0.77; CI 0.51-1.14; p = 0.19). NOAF was significantly more frequent after PFO-C (OR 5.75, CI 3.09-10.70; p < 0.00001). Mortality (OR 0.80, CI 0.39-1.67), major bleeding (OR 0.96, CI 0.48-1.92), and VTE (OR 2.45, CI 0.75-7.99) remained neutral. Trials with superior patient selection for PFO-C showed advantageous results compared to MT.

conclusionsPFO-C after cryptogenic ischemic stroke is safe and effective to reduce the risk of recurrent stroke and recurrent stroke + TIA, albeit with an increased risk for NOAF.

Indexed as

Septal Occluder DeviceBrain IschemiaFibrinolytic AgentsForamen Ovale, PatentHumansRandomized Controlled Trials as TopicRisk FactorsSecondary PreventionThrombolytic TherapyFibrinolytic AgentsClosureCryptogenic strokeOccluderPatent foramen ovalePFO

Identifiers

PMID29500568
OpenAlexW2792534640

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.