{"id":13252,"date":"2011-11-11T14:32:20","date_gmt":"2011-11-11T19:32:20","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=interventional&#038;p=13252"},"modified":"2011-11-11T14:32:20","modified_gmt":"2011-11-11T19:32:20","slug":"shaky-start-ends-staccato","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2011\/11\/11\/shaky-start-ends-staccato\/","title":{"rendered":"Shaky Start Ends STACCATO"},"content":{"rendered":"<p>The STACCATO trial planned to randomize 200 low-risk patients to transcatheter aortic heart valve implantation (TAVI) via the transapical approach (with the Sapien valve from Edwards Lifesciences) or surgical aortic valve replacement (AVR).\u00a0 The primary endpoint was a composite of death, stroke, and renal failure at one month.\u00a0 After enrolling only 70 patients (34 TAVI and 36 surgical AVR), the study was <a href=\"http:\/\/www.eurekalert.org\/pub_releases\/2011-11\/crf-rot_2111011.php\">stopped prematurely by the data safety and monitoring board<\/a> because of an excess of events in the TAVI arm. \u00a0The primary endpoint was met in five patients in the TAVI group (2 deaths, 2 strokes, and 1 case of renal failure) and one patient (stroke) in the AVR group.<\/p>\n<p>It is distinctly unusual to stop a study prematurely after only one third of the enrollment has occurred.<\/p>\n<p><strong><em>What went wrong?<\/em><\/strong><\/p>\n<p>1)\u00a0\u00a0\u00a0\u00a0\u00a0 <a href=\"http:\/\/blogs.nejm.org\/cardioexchange\/news\/tavi-at-tct-enthusiasm-tempered-by-poor-transapical-outcomes\/\">Is TAVI via the transapical approach inherently dangerous?<\/a><\/p>\n<p>2)\u00a0\u00a0\u00a0\u00a0\u00a0 Were the physicians inadequately trained or inept?<\/p>\n<p>3)\u00a0\u00a0\u00a0\u00a0\u00a0 Were the patients selected for TAVI unsuitable for it?<\/p>\n<p>4)\u00a0\u00a0\u00a0\u00a0\u00a0 Is application of TAVI to low-risk patients inappropriate?<\/p>\n<p>As a condition of FDA approval of the Sapien valve, Edwards Lifesciences committed to monitoring the outcomes with the valve through a national registry on transcatheter valve therapy. \u00a0The American College of Cardiology and the Society of Thoracic Surgeons have been working with the FDA and the Centers for Medicare and Medicaid Services to create this national registry, which will serve as a platform for post-market evaluation of the Sapien valve and future transcatheter devices.<\/p>\n<p>However, STACCATO sends a clear message. \u00a0To quote our NASA friends, \u201c<em>Houston, we have a problem.\u201d<strong> \u00a0<\/strong><\/em><\/p>\n<p><strong>It\u2019s critical that we find out what went wrong in STACCATO before Edwards embarks on its ambitious efforts to roll out TAVI to 150-250 sites in the first year of commercialization.<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The STACCATO trial planned to randomize 200 low-risk patients to transcatheter aortic heart valve implantation (TAVI) via the transapical approach (with the Sapien valve from Edwards Lifesciences) or surgical aortic valve replacement (AVR).\u00a0 The primary endpoint was a composite of death, stroke, and renal failure at one month.\u00a0 After enrolling only 70 patients (34 TAVI [&hellip;]<\/p>\n","protected":false},"author":190,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[9],"tags":[423],"class_list":["post-13252","post","type-post","status-publish","format-standard","hentry","category-interventional-cardiology","tag-tavi"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/13252","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\/190"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=13252"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/13252\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=13252"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=13252"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=13252"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}