{"id":15408,"date":"2012-01-18T13:28:14","date_gmt":"2012-01-18T18:28:14","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=15408"},"modified":"2012-01-18T13:28:14","modified_gmt":"2012-01-18T18:28:14","slug":"new-enrollment-in-fame-ii-halted-after-interim-analysis-shows-benefits-of-ffr","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2012\/01\/18\/new-enrollment-in-fame-ii-halted-after-interim-analysis-shows-benefits-of-ffr\/","title":{"rendered":"New Enrollment in FAME II Halted After Interim Analysis Shows Benefits of FFR"},"content":{"rendered":"<p>Following a positive interim analysis showing that fractional flow reserve-guided PCI was superior to optimal medical treatment, an independent data and safety monitoring board (DSMB) has recommended that patient enrollment in\u00a0the ongoing\u00a0<a href=\"http:\/\/clinicaltrials.gov\/ct2\/show\/NCT01132495?term=fame+II&amp;rank=1\">FAME II trial<\/a> be stopped.\u00a0<a href=\"http:\/\/investors.sjm.com\/phoenix.zhtml?c=73836&amp;p=irol-newsArticle&amp;ID=1649160\">The news was announced<\/a>\u00a0by the trial sponsor, St. Jude Medical.<\/p>\n<p>FAME II (Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Plus Optimal Medical Treatment Versus Optimal Medical Treatment Alone in Patients with Stable Coronary Artery Disease) investigators had planned to randomize 1832 patients with stable coronary artery disease to either PCI guided by FFR plus optimal medical treatment (OMT) or OMT alone. At\u00a0the time of the announcement, 1219 patients had been randomized.<\/p>\n<p>According to the company, the DSMB recommendation was based on an increase in the risk of major adverse cardiac events in patients randomized to OMT alone. &#8220;In particular, patients receiving OMT alone experienced a highly statistically significant increased risk of hospital readmission and urgent revascularization, and the DSMB determined that this difference was highly unlikely to change with inclusion of more patients,&#8221; the company stated. There were no significant differences between the groups in the rates of death or MI.<\/p>\n<p>It should be noted that all patients in FAME II underwent FFR\u00a0<em>prior<\/em>\u00a0to randomization, according to\u00a0<a href=\"http:\/\/www.sjm.com\/corporate\/media-room\/media-kits\/patient-conditions-and-therapies\/~\/media\/SJM\/corporate\/Media%20Kits\/PDFs\/FINAL%20FAME%20II.ashx\">the original announcement<\/a>\u00a0of the trial. Patients who had hemodynamically significant lesions as assessed by FFR were then randomized to PCI or OMT. The trial was designed to address the limitations of COURAGE, in which CAD patients as documented by angiography were randomized to PCI or OMT. However, the follow-up to COURAGE,\u00a0<a href=\"http:\/\/www.ischemiatrial.org\/\">the ISCHEMIA trial<\/a>, will randomize ischemic patients to PCI or OMT\u00a0<em>without<\/em>\u00a0prior angiography. FAME II does not appear to address the question of which patients should undergo angiography in the first place.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Following a positive interim analysis showing that fractional flow reserve-guided PCI was superior to optimal medical treatment, an independent data and safety monitoring board (DSMB) has recommended that patient enrollment in\u00a0the ongoing\u00a0FAME II trial be stopped.\u00a0The news was announced\u00a0by the trial sponsor, St. Jude Medical. FAME II (Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Plus Optimal [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-15408","post","type-post","status-publish","format-standard","hentry"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/15408","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=15408"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/15408\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=15408"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=15408"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=15408"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}