{"id":5287,"date":"2010-12-08T06:26:12","date_gmt":"2010-12-08T11:26:12","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?p=5287"},"modified":"2011-07-19T17:44:40","modified_gmt":"2011-07-19T21:44:40","slug":"protect-ii-study-of-impella-stopped-early-for-futility","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2010\/12\/08\/protect-ii-study-of-impella-stopped-early-for-futility\/","title":{"rendered":"PROTECT II Study of Impella Stopped Early for Futility"},"content":{"rendered":"<p>The PROTECT II study has been stopped early. The trial had been comparing the Impella circulatory support device to the intra-aortic balloon in high-risk PCI patients. The trial was terminated after an interim analysis by the Data and Safety Monitoring Board, which reached a \u201cfutility determination\u2026 regarding the primary end-point,\u201d according to a<a href=\"http:\/\/phx.corporate-ir.net\/phoenix.zhtml?c=95629&amp;p=irol-newsArticle&amp;ID=1504992&amp;highlight=\"> press release<\/a> from the trial\u2019s sponsor, Abiomed.<\/p>\n<p>In its press release, Abiomed said the source of the trial&#8217;s problem was likely an unexpected increase in the use of atherectomy in the Impella arm of the trial. The press release quoted the trial PI, William O&#8217;Neill:<\/p>\n<blockquote><p>\u201cAtherectomy was an unanticipated variable which resulted from the operators&#8217; decision to &#8216;do more with Impella.&#8217; Our investigators had unblinded knowledge of the treatment arm after randomization. It is interesting that operators felt that they could do more complex interventions once randomized to Impella and this in and of itself is an important finding.&#8221;<\/p><\/blockquote>\n<p>Abiomed also claimed that a number of &#8220;encouraging results&#8221; were seen in the trial.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The PROTECT II study has been stopped early. The trial had been comparing the Impella circulatory support device to the intra-aortic balloon in high-risk PCI patients. The trial was terminated after an interim analysis by the Data and Safety Monitoring Board, which reached a \u201cfutility determination\u2026 regarding the primary end-point,\u201d according to a press release [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[9],"tags":[604,605,301],"class_list":["post-5287","post","type-post","status-publish","format-standard","hentry","category-interventional-cardiology","tag-impella","tag-intra-aortic-balloon","tag-pci"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/5287","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/196"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=5287"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/5287\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=5287"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=5287"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=5287"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}