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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/cdn\/css\/http\/css_Xg7z6oCTVgud_Q0huYz9x9iiD5H_2YPSJ5z2ZViSWdY.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EThe CLOSURE I trial [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00201461\u0026amp;atom=%2Fspmdc%2F11%2F1%2F16.atom\u0022\u003ENCT00201461\u003C\/a\u003E] was conducted to determine if percutaneous patent foramen ovale closure using the STARFlex\u00ae Septal Closure System in combination with medical therapy, is superior to medical therapy alone to prevent recurrent ischemic neurological symptoms in patients with transient ischemic attack or ischemic stroke.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ENeurology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EInterventional Techniques \u0026amp; Devices\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EEpisodic \u0026amp; Paroxysmal Disorders Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003ELawrence Wechsler, MD, University of Pittsburgh, Pittsburgh, Pennsylvania, presented the results of the CLOSURE I trial (\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00201461\u0026amp;atom=%2Fspmdc%2F11%2F1%2F16.atom\u0022\u003ENCT00201461\u003C\/a\u003E). This trial was conducted to determine if percutaneous patent foramen ovale (PFO) closure using the STARFlex\u00ae Septal Closure System in combination with medical therapy, is superior to medical therapy alone to prevent recurrent ischemic neurological symptoms in patients with transient ischemic attack (TIA) or ischemic stroke.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003ECLOSURE I was a prospective, randomized, open-label, two-arm superiority trial. The study population included patients \u226460 years of age with a cryptogenic TIA or stroke and PFO, with or without atrial septal aneurysm, within 6 months of randomization. The primary endpoint was the 2-year incidence of stroke or TIA, all-cause mortality for the first 30 days, and neurological mortality from \u226531 days of follow-up, as adjudicated by a panel of physicians who were unaware of treatment allocation.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EAt 87 sites in the United States and Canada, subjects were randomized to either best medical therapy (n=462; aspirin 325 mg daily or warfarin [target INR 2.0\u20133.0] or a combination of the two) or percutaneous PFO closure with the STARFlex\u00ae system within 30 days of randomization followed by clopidogrel 75 mg for 6 months and aspirin 325 mg for 24 months (n=447). The mean age of study participants was \u223c46 years. Most (\u223c90%) were white, and approximately 50% were men. Large shunts were significantly (p=0.04) more common in the device group, and atrial septal aneurysms were present in about one-third of each group. About 70% of both groups had stroke as the entry event.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EThere was no significant difference between the two groups in the primary composite endpoint (5.9% in the device group and 7.7% in the medical group; p=0.30) or in either of the individual components: a 3.1% rate of stroke for the device group versus 3.4% for medical therapy (p=0.77); and a 3.3% rate of TIA for the device group versus 4.6% for medical therapy (p=0.39). No significant differences between the groups were noted when subjects with only subcortical or lacunar infarcts were excluded.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EThere were significantly more major vascular complications (eg, perforation; hematoma \u0026gt;5 cm at access site; retroperitoneal bleed) in the device group (3.2% vs 0.0% in the medical group; p\u0026lt;0.001). Significantly (p\u0026lt;0.001) more subjects in the device group experienced atrial fibrillation (AF; 5.7%) versus subjects in the medical group (0.7%). Sixty percent of the AF in the device group was periprocedural; 70% of AF lasted \u0026gt;24 hours. No significant relationship was identified between the rate of TIA or stroke and the presence of atrial septal aneurysm or the degree of PFO shunting. Recurrence rates did not differ between patients who presented with TIA versus stroke.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EAn alternative explanation was apparent for 80% of the recurrent strokes in this study, making it difficult to attribute them to paradoxical embolism. Potential alternate explanations for 9 of the 12 strokes in the device group were as follows: 3 were periprocedural, 3 subjects had typical lacunar events, 2 were associated with new AF, and one was related to cardiac catheterization. Alternative explanations were possible for the 13 strokes in the medical group: 8 subjects had multiple comorbidities (migraine, risk factors, etc), 4 were typical lacunar events, and one subject had possible vasculitis.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2011 MD Conference Express\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/11\/1\/16.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzn4kc\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}