Correction: Device Closure Versus Medical Therapy Alone for Patent Foramen Ovale
Authors: Rahman Shah, MD, Mannu Nayyar, MD, Ion S. Jovin, MD, ScD, Abdul Rashid, MD, Beatrix R. Bondy, MD
Journal: Annals of Internal Medicine (2018)

Corrections18 September 2018Correction: Device Closure Versus Medical Therapy Alone for Patent Foramen OvaleFREEThis correction concerns the following article:ReviewsMar 2018Device Closure Versus Medical Therapy Alone for Patent Foramen Ovale in Patients With Cryptogenic StrokeRahman Shah, MD, Mannu Nayyar, MD, Ion S. Jovin, MD, ScD, Abdul Rashid, MD, Beatrix R. Bondy, MDRahman Shah, MDUniversity of Tennessee and Veterans Affairs Medical Center, Memphis, Tennessee (R.S., M.N., B.R.B., T.M.F.), Mannu Nayyar, MDUniversity of Tennessee and Veterans Affairs Medical Center, Memphis, Tennessee (R.S., M.N., B.R.B., T.M.F.), Ion S. Jovin, MD, ScDVirginia Commonwealth University, Richmond, Virginia (I.S.J.), Abdul Rashid, MDJackson Clinic and University of Tennessee, Jackson, Tennessee (A.R.), Beatrix R. Bondy, MDUniversity of Tennessee and Veterans Affairs Medical Center, Memphis, Tennessee (R.S., M.N., B.R.B., T.M.F.)Author, Article, and Disclosure Informationhttps://doi.org/10.7326/L18-0379 SectionsAboutVisual AbstractPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail There were errors in a recent meta-analysis that compared transcatheter patent foramen ovale (PFO) closure with medical therapy alone for prevention of recurrent stroke in patients with cryptogenic stroke (1). Some patients assigned to medical therapy in 1 of the trials (2) were double-counted. Data for the antiplatelet-only group of the trial (n = 235) are used in this correction because the numbers of events occurring in the anticoagulation group could not be ascertained from the trial report.The second sentence of the Data Synthesis section of the abstract should read as follows: "Four high-quality trials enrolling 2531 [not 2892] patients showed that PFO closure decreased the absolute risk for recurrent stroke by 3.3% [not 3.2%] (risk difference [RD], −0.033 [95% CI, −0.062 to −0.004]) [not −0.032 (95% CI, −0.050 to −0.014)] compared with medical therapy."The I2 value for atrial fibrillation in the abstract should be 81.9%, not 82.5%.In the Methods section under Data Synthesis and Analysis, the seventh sentence should read as follows: "The CLOSE (Patent Foramen Ovale Closure or Anticoagulants versus Antiplatelet Therapy to Prevent Stroke Recurrence) trial had 3 randomization groups: group 1: no contraindications to interventions; group 2: contraindications to oral anticoagulants; and group 3: contraindications to PFO closure). For our primary analysis, we compared the PFO closure (n = 238) to the antiplatelet-only (n = 235) patients from randomization groups 1 and 2," not: "In the CLOSE (Patent Foramen Ovale Closure or Anticoagulants versus Antiplatelet Therapy to Prevent Stroke Recurrence) trial, medical therapy was further stratified into antiplatelet and anticoagulant groups."In the Results section under Outcomes, the first paragraph should read: "Transcatheter device closure of PFO compared with medical therapy alone decreased the absolute risk for recurrent stroke by 3.3% (RD, −0.033 [95% CI, −0.062 to −0.004]; P = 0.037) (Figure 1)," not: "Transcatheter device closure of PFO compared with medical therapy alone decreased absolute risk for recurrent stroke by 3.2% (RD, −0.032 [95% CI, −0.050 to −0.014]; P = 0.011) (Figure 1). The summary result did not change when we used data only from the antiplatelet subgroup (RD, −0.033 [CI, −0.063 to −0.004]; P = 0.037) or anticoagulant subgroup (RD, −0.021 [CI, −0.040 to −0.002]; P = 0.037) from the medical therapy–alone group of the CLOSE trial."In the Results section under Outcomes, the second sentence in the second paragraph should read: "Major bleeding risks did not differ between the two groups (RD, −0.010 [CI, −0.037 to 0.016]; P = 0.24) (Figure 2, middle)," not: "Major bleeding risk did not differ between the 2 groups (RD, −0.021 [CI, −0.051 to 0.009]; P = 0.093) (Figure 2, middle)."In the Methods section under Outcomes, the statistics for heterogeneity (for atrial fibrillation) in the third paragraph should be: "(Q = 16.65; P < 0.001; I2 = 81.9%)," not: "(Q = 17.14; P < 0.001; I2 = 82.5%)."The first sentence of the Discussion section should read: "In this analysis of 2531 patients enrolled in 4 RCTs [randomized controlled trials], we found that transcatheter device closure of PFO decreased the absolute risk for recurrent stroke by 3.3% compared with medical therapy alone in patients with PFO and cryptogenic stroke," not: "In this analysis of 2892 patients enrolled in 4 RCTs, we found that transcatheter device closure of PFO decreased the absolute risk for recurrent stroke by 3.2% compared with medical therapy alone in patients with PFO and cryptogenic stroke."In Table 1, the total number of participants for the medical therapy–alone group for the CLOSE trial was listed incorrectly as 596. The correct number was 425. Also, the explanation of the asterisk was incorrect. It should read: "A total of 425 patients received antiplatelet or anticoagulant treatments following further stratification into 3 subgroups. However, for the main analysis, PFO closure was compared to the antiplatelet-only group (n = 235) from randomization groups 1 and 2," not: "This group was further stratified into the antiplatelet group (n = 409) and the anticoagulant group (n = 187)."Figure 1 and Figure 2 have been replaced with new analyses based on the corrected data and appear in the article.References1. Shah R, Nayyar M, Jovin IS, Rashid A, Bondy BR, Fan TM, et al. Device closure versus medical therapy alone for patent foramen ovale in patients with cryptogenic stroke: a systematic review and meta-analysis. Ann Intern Med. 2018;168:335-42. [PMID: 29310136]. doi:10.7326/M17-2679 LinkGoogle Scholar2. Mas JL, Derumeaux G, Guillon B, Massardier E, Hosseini H, Mechtouff L, et al; CLOSE Investigators. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med. 2017;377:1011-21. [PMID: 28902593] doi:10.1056/NEJMoa1705915 CrossrefMedlineGoogle Scholar Comments0 CommentsSign In to Submit A Comment Author, Article, and Disclosure InformationAffiliations: PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoDevice Closure Versus Medical Therapy Alone for Patent Foramen Ovale in Patients With Cryptogenic Stroke Rahman Shah , Mannu Nayyar , Ion S. Jovin , Abdul Rashid , Beatrix R. Bondy , Tai-Hwang M. Fan , Michael P. Flaherty , and Sunil V. Rao Metrics 18 September 2018Volume 169, Issue 6Page: 428KeywordsAnticoagulant therapyAnticoagulantsAntiplatelet therapyAtrial fibrillationHemorrhageStroke ePublished: 18 September 2018 Issue Published: 18 September 2018 Copyright & PermissionsCopyright © 2018 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...