التفاصيل البيبلوغرافية
| العنوان: |
Closure or medical therapy for cryptogenic stroke with patent foramen ovale. |
| المؤلفون: |
Furlan, Anthony J., Reisman, Mark, Massaro, Joseph, Mauri, Laura, Adams, Harold, Albers, Gregory W., Felberg, Robert, Herrmann, Howard, Kar, Saibal, Landzberg, Michael, Raizner, Albert, Wechsler, Lawrence, CLOSURE I Investigators (CORPORATE AUTHOR) |
| المصدر: |
New England Journal of Medicine. 3/15/2012, Vol. 366 Issue 11, p991-999. 9p. 2 Diagrams. |
| مصطلحات موضوعية: |
*STROKE, *RANDOMIZED controlled trials, *CARDIAC patients, *TRANSIENT ischemic attack, *HEART disease relapse |
| مستخلص: |
Background: The prevalence of patent foramen ovale among patients with cryptogenic stroke is higher than that in the general population. Closure with a percutaneous device is often recommended in such patients, but it is not known whether this intervention reduces the risk of recurrent stroke.Methods: We conducted a multicenter, randomized, open-label trial of closure with a percutaneous device, as compared with medical therapy alone, in patients between 18 and 60 years of age who presented with a cryptogenic stroke or transient ischemic attack (TIA) and had a patent foramen ovale. The primary end point was a composite of stroke or transient ischemic attack during 2 years of follow-up, death from any cause during the first 30 days, or death from neurologic causes between 31 days and 2 years.Results: A total of 909 patients were enrolled in the trial. The cumulative incidence (Kaplan-Meier estimate) of the primary end point was 5.5% in the closure group (447 patients) as compared with 6.8% in the medical-therapy group (462 patients) (adjusted hazard ratio, 0.78; 95% confidence interval, 0.45 to 1.35; P=0.37). The respective rates were 2.9% and 3.1% for stroke (P=0.79) and 3.1% and 4.1% for TIA (P=0.44). No deaths occurred by 30 days in either group, and there were no deaths from neurologic causes during the 2-year follow-up period. A cause other than paradoxical embolism was usually apparent in patients with recurrent neurologic events.Conclusions: In patients with cryptogenic stroke or TIA who had a patent foramen ovale, closure with a device did not offer a greater benefit than medical therapy alone for the prevention of recurrent stroke or TIA. (Funded by NMT Medical; ClinicalTrials.gov number, NCT00201461.). [ABSTRACT FROM AUTHOR] |
| قاعدة البيانات: |
Academic Search Index |
