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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\u003ECryptogenic stroke remains a major challenge for clinicians taking care of patients who have had strokes. Patent foramen ovale (PFO) is a contributor to cryptogenic stroke due to paradoxical embolism [Furlan AJ et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2012], but the optimal management strategy for PFO has yet to be defined [Kitsios GD et al. \u003Cem\u003EStroke\u003C\/em\u003E 2012]. This article reports the results of a follow-up analysis of the RESPECT PFO Clinical Trial [RESPECT; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00465270\u0026amp;atom=%2Fspmdc%2F13%2F1%2F18.atom\u0022\u003ENCT00465270\u003C\/a\u003E] to characterize the qualifying and endpoint ischemic strokes.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ECerebrovascular Disease Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ENeurology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECerebrovascular Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENeurology Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003ECryptogenic stroke remains a major challenge for clinicians taking care of patients who have had strokes. Patent foramen ovale (PFO) is a contributor to cryptogenic stroke due to paradoxical embolism [Furlan AJ et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2012], but the optimal management strategy for PFO has yet to be defined [Kitsios GD et al. \u003Cem\u003EStroke\u003C\/em\u003E 2012]. Jeffrey L. Saver, MD, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA, reported the results of a follow-up analysis of the RESPECT PFO Clinical Trial [RESPECT; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00465270\u0026amp;atom=%2Fspmdc%2F13%2F1%2F18.atom\u0022\u003ENCT00465270\u003C\/a\u003E] to characterize the qualifying and endpoint ischemic strokes.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003ERESPECT included patients aged 18 to 60 with PFO who had a cryptogenic stroke within 270 days. Enrollment continued until the 25th endpoint. Patients were randomized to the device group (n=499) or the medical group (n=481). The device group received closure with the AMPLATZER PFO Occluder plus medical therapy, and the medical group was scheduled to receive 1 of 5 medical treatment regimens (aspirin, warfarin, clopidogrel, or aspirin with dipyridamole); however the fifth treatment regimen of aspirin with clopidogrel was removed from the protocol as it was no longer included in the American Heart Association\/American Stroke Association treatment guidelines.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EPatients were excluded from the trial if they had cerebral, cardiovascular, and\/or systemic conditions that suggested mechanisms other than PFO were responsible for the stroke. These mechanisms included atrial fibrillation, carotid disease, cardiomyopathy, small artery disease, uncontrolled diabetes mellitus or hypertension, arterial hypercoagulable states, or other sources of right-to-left shunt.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EPrimary analysis of the trial has previously shown that there was a 46.6% to 72.7% reduction in risk of stroke in the device versus the medical therapy group [Carrol JD. TCT 2012]. In the follow-up analysis, the basic features of the stroke patients were similar in the device and medical groups. The topography and lesion size of the qualifying strokes were also well balanced between the 2 groups. There was a trend towards magnified value of the device compared with the medical group in patients whose qualifying events occurred in the setting of atrial septal aneurysms (p=0.016), a large shunt size (p=0.012), or in an isolated superficial distribution (p=0.049).\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EThe topography of endpoint ischemic strokes was significantly different between the medical and device groups. The medical group had a larger proportion of strokes that were superficial, mixed superficial and deep, or otherwise not small and deep in distribution compared with the device group (p=0.04). In addition, the medical group experienced more infarcts \u22651.5 cm (69.2%) than the device group (14.3%; p=0.06). \u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E shows a general shift towards larger lesion size in the medical group compared with the device group.\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\/13\/1\/18\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Lesion Size of Endpoint Ischemic Strokes\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1234940613\u0022 data-figure-caption=\u0022Lesion Size of Endpoint Ischemic Strokes\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\/13\/1\/18\/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\/13\/1\/18\/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\/13\/1\/18\/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\/12850\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-7\u0022 class=\u0022first-child\u0022\u003ELesion Size of Endpoint Ischemic Strokes\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EReproduced with permission from JL Saver, MD.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-8\u0022\u003ELimitations of the RESPECT trial include the limited power of the subgroup interaction analysis with only 25 events to explore. In addition, the work-up of endpoint events was incomplete in some cases since some strokes were evaluated at nonstudy centers, and all patients had already had a complete evaluation for qualifying infarcts, so not all tests were repeated in every patient.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EDr. Saver said, \u201cConsideration of the neurovascular aspects of the RESPECT trial reinforce the primary analysis.\u201d When patients were stringently selected to identify those with a history of cryptogenic stroke and PFO, closure with the AMPLATZER PFO Occluder showed evidence of benefit over medical management alone. The device was more effective at averting infarcts associated with a paradoxical embolic stroke mechanism, including those with superficial vascular distribution, convexity strokes, and strokes of larger size, providing additional evidence of a biological effect of closure with the AMPLATZER PFO Occluder.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2013 MD Conference Express\u00ae\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\/13\/1\/18.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?nzo2q1\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?nzo2q1\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}