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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.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\u003EPercutaneous closure of patent foramen ovale does not reduce the risk of recurrent stroke or transient ischemic attack of unknown origin compared with standard medical therapy alone, according to new findings from the CLOSURE I trial.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EInterventional Techniques \u0026amp; Devices Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECerebrovascular Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EInterventional Techniques \u0026amp; Devices\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EEpisodic \u0026amp; Paroxysmal Disorders\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EPercutaneous closure of patent foramen ovale (PFO), an atrial septal defect that epidemiological studies have suggested is associated with cryptogenic stroke, does not reduce the risk of recurrent stroke or transient ischemic attack (TIA) of unknown origin compared with standard medical therapy alone, according to new findings from the CLOSURE I trial.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EThe prospective, randomized, multicenter CLOSURE I trial included 909 patients aged 60 years or younger with a history of cryptogenic stroke or TIA and PFO that was documented by transesophageal echocardiography (TEE) within 6 months of enrollment. Patients were randomly assigned to PFO closure using the STARFlex closure device within 30 days plus 6 months of aspirin and clopidogrel, followed by an additional 18 months of aspirin (n=447) or best medical therapy (n=462), defined as aspirin, warfarin, or the combination of aspirin and warfarin for 24 months.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EThe composite primary endpoint included the 2-year incidence of stroke or TIA, all-cause mortality at 30 days, and neurological mortality between 31 days and 2 years. Anthony J. Furlan, MD, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA, presented findings from the CLOSURE I study.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EAmong the patients who were randomized to the STARFlex closure device, the mean age was 46 years, 52% were male, and 38% had an atrial septal aneurysm \u226510 mm. Procedural success was achieved in 90%. In an intent-to-treat analysis, 5.9% of patients in the PFO closure group and 7.7% of those who were treated with medical therapy alone reached the primary endpoint (p=0.30; \u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E). Stroke risk was also similar in the PFO closure and the medical therapy groups (3.1% vs 3.4%; p=0.77), as was the risk for TIA (3.3% vs 4.6%; p=0.39).\u003C\/p\u003E\u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/10\/10\/22\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Risk of Recurrent Stroke or TIA, All-Cause Mortality, and Neurological Mortality at 2 Years.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-900719016\u0022 data-figure-caption=\u0022Risk of Recurrent Stroke or TIA, All-Cause Mortality, and Neurological Mortality at 2 Years.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/10\/10\/22\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/10\/10\/22\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 1.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/10\/10\/22\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/11388\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption attrib\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-6\u0022 class=\u0022first-child\u0022\u003ERisk of Recurrent Stroke or TIA, All-Cause Mortality, and Neurological Mortality at 2 Years.\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EReproduced with permission from A. Furlan, MD.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-7\u0022\u003EPercutaneous PFO closure was associated with significantly more major vascular complications than medical therapy (3.2% versus 0.0%; p\u0026lt;0.001), as well as an increased risk of atrial fibrillation (5.7% versus 0.7%; p\u0026lt;0.001). Most cases of atrial fibrillation in the device closure group (60%) were periprocedural. Patients in the PFO closure group also showed a trend toward increased major bleeding (2.6% vs 1.1%; p=0.11) but experienced no increase in the risk of nonendpoint deaths (0.5% vs 0.7%) or other serious adverse events (16.9% vs 16.6%).\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EGiven the high procedural success rate, the lack of benefit with PFO closure was not due to device failure. Thrombus formation was observed by TEE in 4 patients (1.0%), including 2 patients with a recurrent stroke on Days 4 and 52, respectively. The majority of patients maintained effective PFO closure, defined as no residual leaks by TEE at 6 months (86.1%), 12 months (86.4%), and 24 months (86.7%). Furthermore, there were no recurrent strokes or TIA in any of the patients with residual leaks. Finally, within the medical treatment group, there was no difference in the primary endpoint between aspirin alone and warfarin alone.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EAmong patients in the CLOSURE I trial who experienced recurrent stroke or TIA during follow-up, approximately 80% had an alternative explanation other than paradoxical embolism, Dr. Furlan said. These findings suggest that cryptogenic stroke and TIA include multiple etiologies other than PFO that are not adequately addressed with PFO closure or current medical therapy.\u003C\/p\u003E\u003Cp id=\u0022p-10\u0022\u003EAlthough the CLOSURE I trial showed no significant improvement with PFO closure over medical therapy alone, PFO closure may be beneficial in better-defined patient subgroups, Dr. Furlan said. Ongoing trials, including the Patent Foramen Ovale Closure or Anticoagulants Versus Antiplatelet Therapy to Prevent Stroke Recurrence (CLOSE) and Patent Foramen Ovale and Cryptogenic Embolism (PC) trials, are examining the role of PFO closure in other patient groups.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2010 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\/10\/10\/22.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_figures.js?nzmn71\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzmn71\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}