Percutaneous closure of patent foramen ovale in cryptogenic embolism

Meier, Bernhard; Kalesan, Bindu; Mattle, Heinrich P.; Khattab, Ahmed Aziz; Hildick-Smith, David; Dudek, Dariusz; Andersen, Grethe; Ibrahim, Reda; Schuler, Gerhard; Walton, Antony S.; Wahl, Andreas; Windecker, Stephan; Jüni, Peter (2013). Percutaneous closure of patent foramen ovale in cryptogenic embolism. New England journal of medicine NEJM, 368(12), pp. 1083-1091. Massachusetts Medical Society MMS 10.1056/NEJMoa1211716

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BACKGROUND The options for secondary prevention of cryptogenic embolism in patients with patent foramen ovale are administration of antithrombotic medications or percutaneous closure of the patent foramen ovale. We investigated whether closure is superior to medical therapy. METHODS We performed a multicenter, superiority trial in 29 centers in Europe, Canada, Brazil, and Australia in which the assessors of end points were unaware of the study-group assignments. Patients with a patent foramen ovale and ischemic stroke, transient ischemic attack (TIA), or a peripheral thromboembolic event were randomly assigned to undergo closure of the patent foramen ovale with the Amplatzer PFO Occluder or to receive medical therapy. The primary end point was a composite of death, nonfatal stroke, TIA, or peripheral embolism. Analysis was performed on data for the intention-to-treat population. RESULTS The mean duration of follow-up was 4.1 years in the closure group and 4.0 years in the medical-therapy group. The primary end point occurred in 7 of the 204 patients (3.4%) in the closure group and in 11 of the 210 patients (5.2%) in the medical-therapy group (hazard ratio for closure vs. medical therapy, 0.63; 95% confidence interval [CI], 0.24 to 1.62; P=0.34). Nonfatal stroke occurred in 1 patient (0.5%) in the closure group and 5 patients (2.4%) in the medical-therapy group (hazard ratio, 0.20; 95% CI, 0.02 to 1.72; P=0.14), and TIA occurred in 5 patients (2.5%) and 7 patients (3.3%), respectively (hazard ratio, 0.71; 95% CI, 0.23 to 2.24; P=0.56). CONCLUSIONS Closure of a patent foramen ovale for secondary prevention of cryptogenic embolism did not result in a significant reduction in the risk of recurrent embolic events or death as compared with medical therapy. (Funded by St. Jude Medical; ClinicalTrials.gov number, NCT00166257.).

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology
04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Neurology
04 Faculty of Medicine > Other Institutions > Teaching Staff, Faculty of Medicine
04 Faculty of Medicine > Pre-clinic Human Medicine > Institute of Social and Preventive Medicine
04 Faculty of Medicine > Pre-clinic Human Medicine > CTU Bern

UniBE Contributor:

Meier, Bernhard; Kalesan, Bindu; Mattle, Heinrich; Khattab, Ahmed Aziz; Wahl, Andreas; Windecker, Stephan and Jüni, Peter

Subjects:

600 Technology > 610 Medicine & health
300 Social sciences, sociology & anthropology > 360 Social problems & social services

ISSN:

0028-4793

Publisher:

Massachusetts Medical Society MMS

Language:

English

Submitter:

Doris Kopp Heim

Date Deposited:

12 Feb 2014 16:56

Last Modified:

16 Jul 2018 14:51

Publisher DOI:

10.1056/NEJMoa1211716

PubMed ID:

23514285

BORIS DOI:

10.7892/boris.40743

URI:

https://boris.unibe.ch/id/eprint/40743

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