Percutaneous closure of patent foramen ovale in cryptogenic embolism


Autoria(s): 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
Data(s)

21/03/2013

Resumo

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.).

Formato

application/pdf

Identificador

http://boris.unibe.ch/40743/1/Meier%20NEnglJMed%202013.pdf

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 <http://dx.doi.org/10.1056/NEJMoa1211716>

doi:10.7892/boris.40743

info:doi:10.1056/NEJMoa1211716

info:pmid:23514285

urn:issn:0028-4793

Idioma(s)

eng

Publicador

Massachusetts Medical Society MMS

Relação

http://boris.unibe.ch/40743/

Direitos

info:eu-repo/semantics/openAccess

Fonte

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 <http://dx.doi.org/10.1056/NEJMoa1211716>

Palavras-Chave #610 Medicine & health #360 Social problems & social services
Tipo

info:eu-repo/semantics/article

info:eu-repo/semantics/publishedVersion

PeerReviewed