Evidence map›Paper›PMID 29590333›Full record

SynthesisEuropean heart journal2018

Patent foramen ovale closure vs. medical therapy for cryptogenic stroke: a meta-analysis of randomized controlled trials.

Yousif Ahmad, James P Howard, Ahran Arnold, Matthew Shun Shin, Christopher Cook, Ricardo Petraco, Ozan Demir, Luke Williams, Juan F Iglesias, Nilesh Sutaria and 5 more

Registry-linked trialAbstract readComparative StudyMeta-Analysis
In one paragraph

Synthesis in European heart journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06504121 (PFO tRanscatether Occlusion Long-term Outcomes National Group), which is not on this map. Cited by 56 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed, 5 pooled it
–field-weighted citation impact
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.

NCT06504121 completednot on this map

PFO tRanscatether Occlusion Long-term Outcomes National Group (PROLONG) Registry

TypeobservationalSponsorIRCCS Ospedale San RaffaeleRan1999 to 2024Enrolled1,360ConditionsPatent Foramen Ovale, Stroke, Cryptogenic, Transient Ischaemic Attack Due to Embolism, Atrial Fibrillation New OnsetArmsSeptal Occluder Device
3 · Its place in the literature

Who cites it

56 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Article
  8. Article
  9. Bioresorbable patent foramen ovale closure-is less more?Cardiovascular diagnosis and therapy · 2026
    Article
  10. Review
  11. Article
  12. Article
  13. Stroke and transient ischemic attack recurrence after PFO closure in patients with cryptogenic embolism.Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation · 2026
    Article
  14. Article
  15. Review
  16. Article
  17. Article
  18. Stroke recurrence after transcatheter PFO closure in patients with cryptogenic stroke.International journal of stroke : official journal of the International Stroke Society · 2025
    Article
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors.

Yousif AhmadNational Heart and Lung Institute, 2nd Floor B Block, Hammersmith Hospital, Imperial College London W12 0HS, UK.
James P HowardNational Heart and Lung Institute, 2nd Floor B Block, Hammersmith Hospital, Imperial College London W12 0HS, UK.
Ahran ArnoldNational Heart and Lung Institute, 2nd Floor B Block, Hammersmith Hospital, Imperial College London W12 0HS, UK.
Matthew Shun ShinNational Heart and Lung Institute, 2nd Floor B Block, Hammersmith Hospital, Imperial College London W12 0HS, UK.
Christopher CookNational Heart and Lung Institute, 2nd Floor B Block, Hammersmith Hospital, Imperial College London W12 0HS, UK.
Ricardo PetracoNational Heart and Lung Institute, 2nd Floor B Block, Hammersmith Hospital, Imperial College London W12 0HS, UK.
Ozan DemirNational Heart and Lung Institute, 2nd Floor B Block, Hammersmith Hospital, Imperial College London W12 0HS, UK.
Luke WilliamsNational Heart and Lung Institute, 2nd Floor B Block, Hammersmith Hospital, Imperial College London W12 0HS, UK.
Juan F IglesiasNational Heart and Lung Institute, 2nd Floor B Block, Hammersmith Hospital, Imperial College London W12 0HS, UK.
Nilesh SutariaNational Heart and Lung Institute, 2nd Floor B Block, Hammersmith Hospital, Imperial College London W12 0HS, UK.
Iqbal MalikNational Heart and Lung Institute, 2nd Floor B Block, Hammersmith Hospital, Imperial College London W12 0HS, UK.
Justin DaviesNational Heart and Lung Institute, 2nd Floor B Block, Hammersmith Hospital, Imperial College London W12 0HS, UK.
Jamil MayetNational Heart and Lung Institute, 2nd Floor B Block, Hammersmith Hospital, Imperial College London W12 0HS, UK.
Darrel FrancisNational Heart and Lung Institute, 2nd Floor B Block, Hammersmith Hospital, Imperial College London W12 0HS, UK.
Sayan SenNational Heart and Lung Institute, 2nd Floor B Block, Hammersmith Hospital, Imperial College London W12 0HS, UK.

Funding

British Heart Foundation FS/10/38/28268British Heart Foundation FS/11/46/28861British Heart Foundation FS/14/27/30752Medical Research Council G1000357Medical Research Council MR/M018369/1Wellcome Trust
6 · The paper itself

Abstract

Aims: The efficacy of patent foramen ovale (PFO) closure for cryptogenic stroke has been controversial. We undertook a meta-analysis of randomized controlled trials (RCTs) comparing device closure with medical therapy to prevent recurrent stroke for patients with PFO. Methods and results: We systematically identified all RCTs comparing device closure to medical therapy for cryptogenic stroke in patients with PFO. The primary efficacy endpoint was recurrent stroke, analysed on an intention-to-treat basis. The primary safety endpoint was new onset atrial fibrillation (AF). Five studies (3440 patients) were included. In all, 1829 patients were randomized to device closure and 1611 to medical therapy. Across all patients, PFO closure was superior to medical therapy for prevention of stroke [hazard ratio (HR) 0.32, 95% confidence interval (95% CI) 0.13-0.82; P = 0.018, I2 = 73.4%]. The risk of AF was significantly increased with device closure [risk ratio (RR) 4.68, 95% CI 2.19-10.00, P<0.001, heterogeneity I2 = 27.5%)]. In patients with large shunts, PFO closure was associated with a significant reduction in stroke (HR 0.33, 95% CI 0.16-0.72; P = 0.005), whilst there was no significant reduction in stroke in patients with a small shunt (HR 0.90, 95% CI 0.50-1.60; P = 0.712). There was no effect from the presence or absence of an atrial septal aneurysm on outcomes (P = 0.994). Conclusion: In selected patients with cryptogenic stroke, PFO closure is superior to medical therapy for the prevention of further stroke: this is particularly true for patients with moderate-to-large shunts. Guidelines should be updated to reflect this.

Indexed as

Septal Occluder DeviceForamen Ovale, PatentHumansRandomized Controlled Trials as TopicRecurrenceStrokeTreatment Outcome

Identifiers

PMID29590333
PMCPMC5946888

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Registered trials

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.