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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\u003EAccording to the Primary Results of the Solitaire\u2122 FR With the Intention for Thrombectomy Multicenter, Randomized Clinical Trial [SWIFT; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01054560\u0026amp;atom=%2Fspmdc%2F12%2F1%2F17.atom\u0022\u003ENCT01054560\u003C\/a\u003E], the Solitaire flow restoration device is superior to the Merci Retrieval System\u00ae in achieving successful recanalization that is free of symptomatic hemorrhagic transformation.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ENeurology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EInterventional Techniques \u0026amp; Devices\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EIschemia\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EAccording to the Primary Results of the Solitaire\u2122 FR With the Intention for Thrombectomy Multicenter, Randomized Clinical Trial [SWIFT; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01054560\u0026amp;atom=%2Fspmdc%2F12%2F1%2F17.atom\u0022\u003ENCT01054560\u003C\/a\u003E], the Solitaire flow restoration (FR) device is superior to the Merci Retrieval System\u00ae in achieving successful recanalization that is almost free of symptomatic hemorrhagic transformation. Jeffrey L. Saver, MD, FAHA, FAAN, UCLA Stroke Center, Los Angeles, California, USA, reported outcomes from the study.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003ESWIFT was a 21-site, blinded endpoint observer, international, active comparator, noninferiority trial that tested the Solitaire\u2122 FR as the initial device against the Merci Retriever\u00ae as the initial device. The purpose of the study was to demonstrate substantial equivalence of the Solitaire FR revascularization device with the legally marketed Merci retrieval system.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EThe primary efficacy endpoint was successful recanalization\u2014TIMI 2 or 3 flow in all treatable vessels\u2014with no symptomatic intracranial hemorrhage, assessed at completion of the first device strategy prior to rescue therapy. Secondary efficacy endpoints were time to recanalization, good neurological outcome at 90 days, and global disability at 90 days. Key inclusion criteria included ability to be treated within 8 hours of onset, National Institute of Health Stroke Scale (NIHSS) 8 to 29, and proximal intracranial occlusion.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EEnrollment totaled 144 patients at 18 sites; 113 were randomized 1:1 to receive treatment with the Solitaire FR (n=58) or Merci device (n=55). All baseline demographic features were similar, with no significant differences. Higher rates of atrial fibrillation (p=0.02) was the only significant difference in medical and neurological history (44.8% in the Solitaire group vs 67.3% in the Merci group).\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EOf the 58 patients who were randomized to Solitaire FR, 60.7% (34\/56) achieved the primary trial endpoint versus 24.1% (13\/54) with the Merci device (noninferiority p\u0026lt;0.0001; superiority p=0.0001). Rescue therapy was used in 20.7% (12\/58) of Solitaire patients versus 43.6% (24\/55) of Merci patients (noninferiority p\u0026lt;0.0001; superiority p=0.015).\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EGood neurological outcomes at 90 days (defined as modified Rankin Scale [mRS] score \u22642 or equal to the prestroke mRS if \u0026gt;2, or NIHSS score improvement \u226510) were achieved by 58.2% (32\/55) of Solitaire patients versus 33.3% (16\/48) of Merci patients (noninferiority p=0.0001; superiority p=0.017). Mortality at 90 days occurred in 17.2% (10\/58) of the Solitaire patients versus 38.2% (21\/55) of the Merci patients (noninferiority p=0.0001; superiority p=0.020).\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EsICH occurred in 1.7% (1\/58) of the Solitaire FR patients versus 10.9% (6\/55) of the Merci patients (noninferiority p\u0026lt;0.0001; superiority p=0.057). Total intracranial hemorrhage percentages were 17.2% in the Solitaire FR group versus 38.2% in the Merci group (noninferiority p=0.0001; superiority p=0.020). In the Solitaire group, 8.6% of patients suffered study device-related serious adverse events (SAEs) versus 16.4% in the Merci group (p=0.26).\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EThe percentages for all procedure-related SAEs were 13.8% in the former versus 16.4% in the latter (p=0.80).\u003C\/p\u003E\u003Cp id=\u0022p-10\u0022\u003EThe first patient was enrolled in February 2010. At the end of July 2011, the trial met the interim efficacy stopping rule and was halted by the Data Safety Monitoring Board, Steering Committee, and sponsor for overwhelming efficacy.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2012 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\/12\/1\/17.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?nzniod\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}