{"id":138948,"date":"2025-11-09T01:58:41","date_gmt":"2025-11-09T06:58:41","guid":{"rendered":"https:\/\/cardiologynownews.org\/?p=138948"},"modified":"2026-01-28T19:23:52","modified_gmt":"2026-01-29T00:23:52","slug":"vesalius-cv-pcsk9-inhibitor-evolocumab-reduces-mace-for-primary-prevention","status":"publish","type":"post","link":"https:\/\/cardiologynownews.org\/?p=138948","title":{"rendered":"VESALIUS-CV: PCSK9-Inhibitor Evolocumab Reduces MACE for Primary Prevention"},"content":{"rendered":"<p>Key Points:<\/p>\n<ul>\n<li>PCSK9-inhibitors \u2013 including evolocumab \u2013 are highly effective LDL-C\u2013lowering medications that reduce major adverse cardiovascular events (MACE) in patients who have had a previous cardiovascular (CV) event, such as a prior myocardial infarction (MI) or stroke.<\/li>\n<li>Evolocumab was associated with a significant 25% relative risk reduction in a composite of coronary heart disease death, MI, or ischemic stroke compared with placebo in this population.<\/li>\n<li>This is the first trial to demonstrate that any non-statin LDL-C\u2013lowering therapy reduces major CV events in a primary prevention population.<\/li>\n<\/ul>\n<p><!--more--><\/p>\n<p>Previous studies have demonstrated that the proprotein convertase subtilisin\u2013kexin type 9 (PCSK9) inhibitor evolocumab reduces the risk of MACE among patients with a previous myocardial infarction, stroke, or symptomatic peripheral artery disease. However, whether evolocumab helps reduce MACE in patients without a prior MI or stroke is uncertain.<\/p>\n<p>On November 8th, 2025, the results of \u201cEvolocumab in Patients without a Previous Myocardial Infarction or Stroke\u201d (NCT03872401) were presented at the American Heart Association Scientific Sessions in New Orleans, LA, with simultaneous publication in <a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2514428\"><em>The New England Journal of Medicine<\/em><\/a>. The purpose of this trial was to determine whether evolocumab reduces MACE in a high-risk primary prevention population.<\/p>\n<p>This international, double-blind, randomized, placebo-controlled trial randomized 12,257 participants with atherosclerosis or diabetes and without a previous myocardial infarction or stroke, who had an LDL-C level of \u226590 mg\/dL, in a 1:1 ratio to evolocumab at a dose of 140 mg every 2 weeks or placebo. The two primary composite endpoints were 3-point MACE (death from coronary heart disease, myocardial infarction, or ischemic stroke) and 4-point MACE (3-point MACE plus ischemia-driven revascularization). The mean age of participants was 66 years, 43% were female, 93% were White, 67% had atherosclerosis, and 33% had diabetes without atherosclerosis. Over 90% were on background lipid-lowering therapy (68% on high-intensity statins), with a mean LDL-C of 122 mg\/dL.<\/p>\n<p>Compared to placebo, evolocumab was associated with a 19% relative risk reduction in the primary endpoint of 4-point MACE (16.2% vs. 13.4%; HR 0.81 [95% CI: 0.73, 0.89]) and a 25% relative risk reduction in 3-point MACE (8.0% vs. 6.2%; HR 0.75 [95% CI: 0.65, 0.86]) at five years. The median achieved LDL-C was 45 mg\/dL. In hypothesis-generating secondary endpoints, evolocumab was also associated with reductions in CV death and all-cause death. Results were consistent across key subgroups, including those with diabetes but no atherosclerosis. Limitations include a population that was 93% White and a small proportion of patients (8%) who were not on background lipid-lowering therapy.<\/p>\n<p>Erin Ann Bohula, MD, DPhil, FACC, of Brigham and Women\u2019s Hospital in Boston, MA, concluded: \u201cThe results from the VESALIUS-CV trial represent the first demonstration of improved cardiovascular outcomes with a PCSK9 inhibitor, or any non-statin for that matter, in patients without a previous heart attack or stroke who are already being treated with a high-intensity lipid-lowering regimen.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Key Points: PCSK9-inhibitors \u2013 including evolocumab \u2013 are highly effective LDL-C\u2013lowering medications that reduce major adverse cardiovascular events (MACE) in patients who have had a previous cardiovascular (CV) event, such as a prior myocardial infarction (MI) or stroke. Evolocumab was associated with a significant 25% relative risk reduction in a composite of coronary heart disease [&hellip;]<\/p>\n","protected":false},"author":40618,"featured_media":138950,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"aside","meta":{"footnotes":""},"categories":[906],"tags":[908,45,82,47,119,185],"ppma_author":[1072],"class_list":{"0":"post-138948","1":"post","2":"type-post","3":"status-publish","4":"format-aside","5":"has-post-thumbnail","7":"category-aha-2025","8":"tag-aha2025","9":"tag-conference","10":"tag-coronary-artery-disease","11":"tag-featured","12":"tag-interventional-cardiology","13":"tag-news","14":"post_format-post-format-aside","15":"author-lucas-marinacci-md"},"authors":[{"term_id":1072,"user_id":40618,"is_guest":0,"slug":"lucas-marinacci-md","display_name":"Lucas Marinacci MD","avatar_url":"https:\/\/secure.gravatar.com\/avatar\/cd81d2064c6f6263719c24aeb738faf718e9bd869c5a840718bc535238ae72f6?s=96&r=g","0":null,"1":"","2":"","3":"","4":"","5":"","6":"","7":"","8":""}],"_links":{"self":[{"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts\/138948","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/users\/40618"}],"replies":[{"embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=138948"}],"version-history":[{"count":1,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts\/138948\/revisions"}],"predecessor-version":[{"id":138951,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts\/138948\/revisions\/138951"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/media\/138950"}],"wp:attachment":[{"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=138948"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=138948"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=138948"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fppma_author&post=138948"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}