{"id":27576,"date":"2012-03-26T17:28:38","date_gmt":"2012-03-26T21:28:38","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=27576"},"modified":"2012-03-26T17:28:38","modified_gmt":"2012-03-26T21:28:38","slug":"rivaroxaban-found-safe-and-effective-for-pulmonary-embolism","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2012\/03\/26\/rivaroxaban-found-safe-and-effective-for-pulmonary-embolism\/","title":{"rendered":"Rivaroxaban Found Safe and Effective for Pulmonary Embolism"},"content":{"rendered":"<p>In recent years rivaroxaban has been found to be effective in the prevention of venous thromboembolism (VTE) after orthopedic surgery, for the prevention of stroke in AF patients, and as additional therapy to conventional antiplatelet therapy in ACS patients. Now, a study presented at the American College of Cardiology meeting in Chicago and\u00a0<a href=\"http:\/\/www.nejm.org\/doi\/pdf\/10.1056\/NEJMoa1113572\">published simultaneously in the\u00a0<em>New England Journal of Medicine\u00a0<\/em><\/a>offers strong evidence that rivaroxaban is equally effective as standard therapy for the treatment of pulmonary embolism and may cause fewer bleeding complications.<\/p>\n<p>EINSTEIN-PE was a\u00a0randomized, open-label, non-inferiority study comparing rivaroxaban to conventional therapy with enoxaparin and a vitamin K antagonist in 4,832 patients with\u00a0pulmonary embolism. Rivaroxaban met the predefined margin for noninferiority to conventional treatment with respect to\u00a0both clinical efficacy and safety.<\/p>\n<p>Primary efficacy endpoint (first symptomatic recurrent VTE):<\/p>\n<ul>\n<li>2.1% \u00a0for rivaroxaban patients versus 1.8% for standard therapy (HR, 1.12; 95% CI, 0.75-1.68; P=0.003 for noninferiority)<\/li>\n<\/ul>\n<p>Principal safety outcome (major or clinically relevant bleeding):<\/p>\n<ul>\n<li>10.3% versus 11.4% (HR, 0.90; 95% CI, 0.76-1.07; P=0.23 for noninferiority) for\u00a0rivaroxaban and standard therapy, respectively<\/li>\n<\/ul>\n<p>Major bleeding was significantly lower in the rivaroxaban group:<\/p>\n<ul>\n<li>\u00a01.1% versus 2.2% (HR, 0.49; P=0.003)\u00a0for\u00a0rivaroxaban and standard therapy, respectively<\/li>\n<\/ul>\n<p>Net clinical benefit (VTE plus major bleeding):<\/p>\n<ul>\n<li>3.4% versus 4.0% (HR, 0.85; 95% CI, 0.63-1.14; P=0.28)\u00a0for\u00a0rivaroxaban and standard therapy, respectively<\/li>\n<\/ul>\n<div>\n<div>\n<p>\u201cPhysicians want to know about major bleeding, the most important safety outcome, and rivaroxaban was highly significantly superior. This was our most astonishing finding,\u201d said EINSTEIN chair Harry Buller in an ACC press release. \u201cRivaroxaban is just as good as standard treatment for PE \u2013 these data are pretty convincing \u2013 and this is an oral-only approach, which makes it very simple. The subcutaneous injections can be hazardous as well.\u201d<\/p>\n<p>The EINSTEIN investigators concluded that, in conjunction with the earlier EINSTEIN trial in DVT, the EINSTEIN PE trial supports &#8220;the use of rivaroxaban as a single oral agent for patients with venous thromboembolism.&#8221;<\/p>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>In recent years rivaroxaban has been found to be effective in the prevention of venous thromboembolism (VTE) after orthopedic surgery, for the prevention of stroke in AF patients, and as additional therapy to conventional antiplatelet therapy in ACS patients. Now, a study presented at the American College of Cardiology meeting in Chicago and\u00a0published simultaneously in [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[495,16],"tags":[1191,596,366],"class_list":["post-27576","post","type-post","status-publish","format-standard","hentry","category-anticoagulation-2","category-vascular","tag-pe","tag-pulmonary-embolism","tag-rivaroxaban"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/27576","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=27576"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/27576\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=27576"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=27576"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=27576"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}