{"id":10764,"date":"2011-08-10T17:00:35","date_gmt":"2011-08-10T21:00:35","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=10764"},"modified":"2011-08-10T18:57:23","modified_gmt":"2011-08-10T22:57:23","slug":"rivaroxaban-compared-with-warfarin-in-14000-af-patients","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2011\/08\/10\/rivaroxaban-compared-with-warfarin-in-14000-af-patients\/","title":{"rendered":"Rivaroxaban Compared with Warfarin in 14,000 AF Patients"},"content":{"rendered":"<p>In ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation), researchers tested rivaroxaban (20 mg\/day) against warfarin in 14,264 patients with nonvalvular atrial fibrillation (AF). The results of the trial, which were <a href=\"http:\/\/blogs.nejm.org\/cardioexchange\/news\/rocket-af-hits-chicago\/\">first presented last November at the American Heart Association meeting<\/a>, have now been <a href=\"http:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa1009638\">published in the <em>New England Journal of Medicine<\/em><\/a>.<\/p>\n<p>The primary per-protocol analysis demonstrated that rivaroxaban was noninferior to warfarin: the rate of stroke or systemic embolism was 1.7% per year in the rivaroxaban group compared with 2.2% per year in the warfarin group (HR for rivaroxaban: 0.79, CI 0.66-0.96, p&lt;0.001 for noninferiority).<\/p>\n<p>The intention-to-treat analysis also demonstrated noninferiority but did not demonstrate superiority: the event rate was 2.1% per year with rivaroxaban compared with 2.4% per year with warfarin (HR 0.88, CI 0.74-1.03, p&lt;0.001 for noninferiority, p=0.12 for superiority).<\/p>\n<p>The ROCKET AF investigators write that the difference between the two analyses &#8220;reflects the fact that among patients who discontinued therapy before the conclusion of the trial, no significant difference in outcomes would have been anticipated, and none was seen.&#8221;<\/p>\n<p>The rate of major and nonmajor clinically relevant bleeding did not differ significantly between the two groups, but rivaroxaban was associated with significant reductions in intracranial hemorrhage and fatal bleeds:<\/p>\n<ul>\n<li>Major and nonmajor clinically relevant bleeding: 14.9% per year with rivaroxaban and 14.5% per year with warfarin, HR 1.03, CI 0.96-1.11, p=0.44)<\/li>\n<li>Intracranial hemorrhage: 0.5% versus 0.7%, p=0.02<\/li>\n<li>Fatal bleeding: 0.2% versus 0.5%, p=0.003<\/li>\n<\/ul>\n<p>In<a href=\"http:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMe1107516\"> an accompanying editorial<\/a>, Gregory del Zoppo and Misha Eliasziw note that treatment with both rivaroxaban in ROCKET AF and dabigatran in RE-LY resulted in a lower rate of intracranial hemorrhage compared with warfarin, although no difference in overall major bleeding events was observed in either trial. They speculate that cerebral vascular beds may &#8220;have protective features that are more apparent at the doses of either of the new agents tested.&#8221;<\/p>\n<p>The editorialists conclude that &#8220;oral alternatives to warfarin have arrived,&#8221; but hedge their enthusiasm by noting that &#8220;comparisons seem to depend on how easily the patient can be treated with warfarin.&#8221;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>In ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation), researchers tested rivaroxaban (20 mg\/day) against warfarin in 14,264 patients with nonvalvular atrial fibrillation (AF). The results of the trial, which were first presented last November at the American [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[495,13],"tags":[366,342,489],"class_list":["post-10764","post","type-post","status-publish","format-standard","hentry","category-anticoagulation-2","category-electrophysiology","tag-rivaroxaban","tag-spaf","tag-stroke-prevention"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/10764","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=10764"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/10764\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=10764"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=10764"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=10764"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}