{"id":5273,"date":"2010-12-08T15:28:10","date_gmt":"2010-12-08T20:28:10","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?p=5273"},"modified":"2011-07-19T17:45:11","modified_gmt":"2011-07-19T21:45:11","slug":"rocket-af-stroke-prevention-and-beyond","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2010\/12\/08\/rocket-af-stroke-prevention-and-beyond\/","title":{"rendered":"ROCKET-AF: Stroke Prevention and Beyond!"},"content":{"rendered":"<p><em>The ROCKET-AF trial, which was recently presented at AHA, showed that the experimental factor Xa inhibitor rivaroxaban  was as effective as warfarin in preventing stroke in 14,264 AF patients  and did not increase their risk of bleeding. CardioExchange welcomes one of the trial&#8217;s investigators, <strong>Manesh Patel <\/strong>of the Duke Clinical Research Institute, to answer our questions about ROCKET-AF.<\/em><\/p>\n<p><strong>Q: Not surprisingly, ROCKET-AF has generated a lot of interest both at AHA and beyond.\u00a0 It seems the effects in the rivaroxaban arm of the trial were similar compared to those seen in the warfarin arm, regardless of patients&#8217; time in therapeutic INR range during the trial.\u00a0 What about patients who were previously stable on warfarin, which is a subgroup that did not seem to benefit from dabigatran?<\/strong><\/p>\n<p>A: The effects of rivaroxaban were similar in both patients who were previously treated with vitamin K anatagonists (VKAs) and those who were naive to VKAs.<\/p>\n<p><strong>Q: Were the effects similar across all ranges of CHADS scores, with respect to trends and\/or interaction terms?<\/strong><\/p>\n<p>A: As described, the mean CHADs score was 3.5.\u00a0 The treatment effect was qualitatively consistent across all ranges of CHADS scores (2-6) with larger confidence intervals for the groups with smaller number of patients. There was no statistical interaction for effect across the CHADS scores.<br \/>\n<strong><br \/>\nQ: With respect to the superiority analysis, was this prespecified to be modified or non-modified intention to treat?<\/strong><\/p>\n<p>A: As stated, once noninferiority was established, the superiority analysis was prespecified to be analyzed first in patients who took at least one dose of the study drug with events while on treatment, and then by intention-to-treat principle.<\/p>\n<p><strong>Q: Given these data on rivaroxaban, now adding to the available data on dabigatran in a lower-risk sample, is there anybody whom you think should remain on warfarin as opposed to being on either of these two new agents?<\/strong><\/p>\n<p>A: There may be patients who have been stable on warfarin for years that may not need to be changed.\u00a0 However, for AF patients going on to therapy there are now good alternatives.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The ROCKET-AF trial, which was recently presented at AHA, showed that the experimental factor Xa inhibitor rivaroxaban was as effective as warfarin in preventing stroke in 14,264 AF patients and did not increase their risk of bleeding. CardioExchange welcomes one of the trial&#8217;s investigators, Manesh Patel of the Duke Clinical Research Institute, to answer our [&hellip;]<\/p>\n","protected":false},"author":154,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-5273","post","type-post","status-publish","format-standard","hentry","category-general"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/5273","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\/154"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=5273"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/5273\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=5273"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=5273"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=5273"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}