Evidence map›Paper›PMID 32921262›Full record

Trial reportStroke2020

Risk of Paradoxical Embolism (RoPE)-Estimated Attributable Fraction Correlates With the Benefit of Patent Foramen Ovale Closure: An Analysis of 3 Trials.

David M Kent, Jeffrey L Saver, Robin Ruthazer, Anthony J Furlan, Mark Reisman, John D Carroll, Richard W Smalling, Peter Jüni, Heinrich P Mattle, Bernhard Meier and 1 more

2 registry-linked trialsOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Stroke, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 44 papers.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed
5.7field-weighted citation impact, top 3% 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.

NCT05907694 narecruitingnot on this mapstarted 2024, after this paper: background citation

Medical Treatment With or Without Transcatheter Patent Foramen Ovale CloSure for Older Patients With CrypTogenic StrOke and Patent Foramen Ovale. The STOP Trial

TypeinterventionalSponsorJosep Rodes-CabauRan2024 to 2037Enrolled714ConditionsPatent Foramen Ovale, Cryptogenic Stroke, Older Patients, Medical TreatmentArmsTranscatheter PFO closure, Optimal medical treatment
NCT06983795 not yet recruitingnot on this mapstarted 2025, after this paper: background citation

Pioneering Advancements in Cardiocerebrovascular Interactions in the Asia pacFIC - Patent Foramen Ovale Study

Typeobservational_patient_registrySponsorNational University Hospital, SingaporeRan2025 to 2030Enrolled1,000ConditionsIschemic Stroke, Patent Foramen OvaleArmsPFO closure using approved PFO closure devices, Surgical PFO closure, Medical management
3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 92 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Review
  14. Stroke recurrence after transcatheter PFO closure in patients with cryptogenic stroke.International journal of stroke : official journal of the International Stroke Society · 2025
    Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Review
  20. 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

11 authors at 8 institutions in 4 countries.

David M KentPredictive Analytics and Comparative Effectiveness (PACE) Center, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center/Tufts University School of Medicine, Boston, MA. (D.M.K., R.R.).
Jeffrey L SaverComprehensive Stroke Center and Department of Neurology, David Geffen School of Medicine/University of California Los Angeles (J.L.S.).
Robin RuthazerPredictive Analytics and Comparative Effectiveness (PACE) Center, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center/Tufts University School of Medicine, Boston, MA. (D.M.K., R.R.).
Anthony J FurlanDepartment of Neurology, Case Western Reserve University, Cleveland, OH (A.J.F.).
Mark ReismanDivision of Cardiology, University of Washington Medical Center, Seattle (M.R.).
John D CarrollDivision of Cardiology, Department of Medicine, University of Colorado Denver, Aurora (J.D.C.).
Richard W SmallingDivision of Cardiology, Department of Medicine, University of Texas Medical School at Houston (R.W.S.).
Peter JüniApplied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Department of Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, ON, Canada (P.J.).
Heinrich P MattleDepartment of Neurology, Bern University Hospital, Bern, Switzerland. (H.P.M.).
Bernhard MeierDepartment of Cardiology, Bern University Hospital, Bern, Switzerland. (B.M.).
David E ThalerDepartment of Neurology, Tufts Medical Center/Tufts University School of Medicine, Boston, MA. (D.M.K., D.E.T.).
Tufts University · USUniversity Hospital of Bern · CHCase Western Reserve University · USSt. Michael's Hospital · CATexas Medical Center · USUniversity of California, Los Angeles · USUniversity of Colorado Denver · USUniversity of Washington Medical Center · US

Funding

Tufts Clinical and Translational Science Institute (Pilot Supplement)UL1TR002544 · NCATS · TUFTS UNIVERSITY BOSTON · PI SELKER, HARRY P. · 2018 to 2022
$50.2M
NCATS NIH HHS UL1 TR002544Patient-Centered Outcomes Research Institute RR-1705-0001
6 · The paper itself

Abstract

background and purposeIn patients with cryptogenic stroke and patent foramen ovale (PFO), the Risk of Paradoxical Embolism (RoPE) Score has been proposed as a method to estimate a patient-specific "PFO-attributable fraction"-the probability that a documented PFO is causally-related to the stroke, rather than an incidental finding. The objective of this research is to examine the relationship between this RoPE-estimated PFO-attributable fraction and the effect of closure in 3 randomized trials.

methodsWe pooled data from the CLOSURE-I (Evaluation of the STARFlex Septal Closure System in Patients With a Stroke and/or Transient Ischemic Attack due to Presumed Paradoxical Embolism through a Patent Foramen Ovale), RESPECT (Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment), and PC (Clinical Trial Comparing Percutaneous Closure of Patent Foramen Ovale [PFO] Using the Amplatzer PFO Occluder With Medical Treatment in Patients With Cryptogenic Embolism) trials. We examine the treatment effect of closure in high RoPE score (≥7) versus low RoPE score (<7) patients. We also estimated the relative risk reduction associated with PFO closure across each level of the RoPE score using Cox proportional hazard analysis. We estimated a patient-specific attributable fraction using a PC trial-compatible (9-point) RoPE equation (omitting the neuroradiology variable), as well as a 2-trial analysis using the original (10-point) RoPE equation. We examined the Pearson correlation between the estimated attributable fraction and the relative risk reduction across RoPE strata.

resultsIn the low RoPE score group (<7, n=912), the rate of recurrent strokes per 100 person-years was 1.37 in the device arm versus 1.68 in the medical arm (hazard ratio, 0.82 [0.42-1.59]

conclusionsThe RoPE score estimated attributable fraction is highly correlated to the relative risk reduction of device versus medical therapy. This observation suggests the RoPE score identifies patients with cryptogenic stroke who are likely to have a PFO that is pathogenic rather than incidental.

Indexed as

Cardiac CatheterizationEmbolism, ParadoxicalForamen Ovale, PatentHumansRisk FactorsSecondary PreventionStrokeTreatment Outcomeembolism, paradoxicalforamen ovale, patentpatientspredictionrisk

Identifiers

PMID32921262
PMCPMC7831886
OpenAlexW3085403542

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.