{"id":7584,"date":"2011-04-05T12:07:24","date_gmt":"2011-04-05T16:07:24","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?p=7584"},"modified":"2011-07-19T17:44:28","modified_gmt":"2011-07-19T21:44:28","slug":"magellan-higher-bleeding-rates-cloud-rivaroxabans-effect-in-vte-prevention-in-acutely-ill-medical-patients","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2011\/04\/05\/magellan-higher-bleeding-rates-cloud-rivaroxabans-effect-in-vte-prevention-in-acutely-ill-medical-patients\/","title":{"rendered":"MAGELLAN: Higher Bleeding Rates Cloud Rivaroxaban&#8217;s Effect in VTE Prevention in Acutely Ill Medical Patients"},"content":{"rendered":"<p>The novel anticoagulant rivaroxaban is successful in preventing venous  thromboembolism (VTE) in acutely ill medical patients, but a high  bleeding rate means the drug probably won&#8217;t be used for this indication.  Alexander Cohen, presenting the results of the MAGELLAN trial at the  ACC in New Orleans, explained by way of background that 50% to 70% of  symptomatic thromboembolic events occur in nonsurgical patients.<\/p>\n<p>Some 8,101 patients were randomized to either oral rivaroxaban for 35 days  or subcutaneous enoxaparin for 10 days followed by placebo. Among the findings:<\/p>\n<ul>\n<li>At 10 days, the primary efficacy measure &#8211; a   composite of  asymptomatic proximal DVT,   symptomatic DVT, symptomatic nonfatal  PE,  and VTE-related death &#8211;\u00a0 demonstrated that rivaroxaban was noninferior to  enoxaparin. The primary outcome occurred in 2.7% of patients in each group  (RR = 0.968; p=0.0025).<\/li>\n<li>At 35  days, rivaroxaban was  significantly better than enoxaparin  and placebo, as the composite endpoint was reached by  4.4%\u00a0 of patients on rivaroxaban versus 5.7% on enoxaparin and placebo (RR 0.771,  p=0.0211).<\/li>\n<\/ul>\n<p>However, there was a significantly increased risk for bleeding with  rivaroxaban at both 10 and 35 days:<\/p>\n<ul>\n<li>At 10 days, clinically relevant bleeding occurred in 2.8% of  rivaroxaban patients versus 1.2% of enoxaparin patients (RR=2.3; p&lt; 0.0001).<\/li>\n<li>At 35 days, clinically relevant bleeding occurred in 4.1% of  rivaroxaban patients versus 1.7%\u00a0  of    enoxaparin patients (RR=2.5; p&lt;0.0001).<\/li>\n<\/ul>\n<p>At day 35, the net clinical benefit &#8211; defined as the composite of  asymptomatic proximal DVT, symptomatic DVT, symptomatic nonfatal PE,  \u000bVTE-related death, and treatment-emergent major plus non-major clinically  relevant bleeding &#8211; occurred in 9.4% of the rivaroxaban group versus 7.8%  of the enoxaparin\/placebo group.<\/p>\n<p>In response to a question after his presentation, Cohen explained  that very few AF patients were enrolled in the trial because most of  them would already have been receiving anticoagulation.<\/p>\n<p><em>For more of our ACC.11 coverage of late-breaking clinical trials,   interviews with the authors of the most important research, and blogs   from our fellows on the most interesting presentations at the meeting,   check out our <a href=\"..\/acc-11-cardioexchange-coverage-roundup\/\">Coverage Roundup<\/a>.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The novel anticoagulant rivaroxaban is successful in preventing venous thromboembolism (VTE) in acutely ill medical patients, but a high bleeding rate means the drug probably won&#8217;t be used for this indication. Alexander Cohen, presenting the results of the MAGELLAN trial at the ACC in New Orleans, explained by way of background that 50% to 70% [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[495,1,16],"tags":[492,220,366],"class_list":["post-7584","post","type-post","status-publish","format-standard","hentry","category-anticoagulation-2","category-general","category-vascular","tag-anticoagulation","tag-enoxaparin","tag-rivaroxaban"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/7584","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=7584"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/7584\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=7584"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=7584"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=7584"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}