{"id":139678,"date":"2026-03-29T02:32:36","date_gmt":"2026-03-29T06:32:36","guid":{"rendered":"https:\/\/cardiologynownews.org\/?p=139678"},"modified":"2026-03-29T02:32:37","modified_gmt":"2026-03-29T06:32:37","slug":"evolocumab-reduces-cv-risk-in-diabetic-patients-without-ascvd-vesalius-cv-trial","status":"publish","type":"post","link":"https:\/\/cardiologynownews.org\/?p=139678","title":{"rendered":"Evolocumab Reduces CV Risk in Diabetic Patients Without ASCVD: VESALIUS-CV Trial"},"content":{"rendered":"\n<p>Key Points<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>In high-risk patients without known significant atherosclerosis and with diabetes, evolocumab reduced the risk of a first major cardiovascular event.<\/li>\n\n\n\n<li>LDL-C reduction was profound at approximately\u00a051%, achieving levels near 40-45 mg\/dL.\u00a0<\/li>\n\n\n\n<li>This is the first randomized controlled trial that\u00a0demonstrates\u00a0that\u00a0a PCSK-9 inhibitor improves outcomes in a primary-prevention population.\u00a0<\/li>\n\n\n\n<li>The medication safety profile was consistent with prior studies, with no major new concerns.\u00a0<\/li>\n<\/ul>\n\n\n\n<p>Lowering low-density lipoprotein cholesterol (LDL-C) is a cornerstone of cardiovascular prevention, with statins forming the foundation of therapy. While PCSK-9 inhibitors\u00a0such as\u00a0evolocumab\u00a0have\u00a0demonstrated\u00a0outcome benefits in secondary prevention, their role in primary prevention,\u00a0particularly among high-risk individuals without prior myocardial infarction (MI) or stroke,\u00a0remained uncertain. The VESALIUS- CV trial showed that PCSK9 inhibition with evolocumab led to a lower risk of first cardiovascular events than placebo among patients with atherosclerosis or diabetes and without a previous myocardial infarction or stroke. A prespecified analysis of this study assessed whether evolocumab could prevent a first major cardiovascular event (MACE) in patients without known significant atherosclerosis<em>.<\/em> The main trial results were presented at ACC with simultaneous publication in <a href=\"https:\/\/jamanetwork.com\/journals\/jama\/fullarticle\/2847162?guestAccessKey=ab0701f0-cada-4144-9cd8-82ff03fa6f9b&amp;utm_source=for_the_media&amp;utm_medium=referral&amp;utm_campaign=ftm_links&amp;utm_content=tfl&amp;utm_term=032826\">JAMA<\/a>.<\/p>\n\n\n\n<p>VESALIUS-CV (ClinicalTrials.gov: <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT03872401\">NCT03872401<\/a>) was a global, randomized, double-blind, placebo-controlled phase 3 trial enrolling 12,257 patients with atherosclerosis or high-risk diabetes but no prior MI or stroke. Participants had elevated atherogenic lipoproteins despite optimized lipid-lowering therapy and were randomized 1:1 to\u00a0evolocumab\u00a0140 mg\u00a0subcutaneously every 2 weeks or placebo. The dual primary endpoints included composites of coronary heart disease (CHD) death, MI, or ischemic stroke (3-P MACE), and an expanded composite including revascularization (4-P MACE).\u00a0Median\u00a0follow-up was 4.8 years.\u00a0<\/p>\n\n\n\n<p>This predefined subgroup included 3655 patients (1849 in the evolocumab group and 1806 in the placebo group) with a median age of 65 years (57%female). Among those in the lipid sub study, the median LDL-C level at 48 weeks was 52mg\/dL in the evolocumab group vs 111mg\/dL in the placebo group (P &lt; .001). A 3-P MACE event occurred in 83 patients (5-year Kaplan-Meier estimate, 5.0%) in the evolocumab group compared with 117 patients (5-year Kaplan-Meier estimate, 7.1%) in the placebo group (hazard ratio [HR], 0.69 [95%CI, 0.52-0.91]; P = .009; between-group difference, 2.1%[95%CI, 0.4%-3.8%]). A 4-P MACE event occurred in 127 patients (5-year Kaplan-Meier estimate, 7.6%) in the evolocumab group compared with 178 patients (5-year Kaplan-Meier estimate, 10.5%) in the placebo group (HR, 0.69 [95%CI, 0.55-0.86]; P = .001; between-group difference, 2.9%[95%CI, 0.9%-4.9%]). There were 136 deaths (5-year Kaplan-Meier estimate, 7.8%) in the evolocumab group compared with 172 deaths (5-year Kaplan-Meier estimate, 10.1%) in the placebo group (HR, 0.76 [95%CI, 0.61-0.95]).<\/p>\n\n\n\n<p>VESALIUS-CV extends the paradigm of intensive lipid lowering into earlier stages of cardiovascular disease,&nbsp;demonstrating&nbsp;that aggressive LDL-C reduction can prevent first events in high-risk populations.&nbsp;One key limitation is the&nbsp;relatively homogeneous&nbsp;study population and underrepresentation of diverse racial and ethnic groups, which may affect generalizability.&nbsp;Additionally,&nbsp;considerations&nbsp;regarding&nbsp;cost, access, and long-term adherence remain important for widespread implementation.&nbsp;However, these study findings support a broader role for PCSK9 inhibitors alongside statins, particularly in patients with residual risk despite guideline-directed therapy.&nbsp;<\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Key Points Lowering low-density lipoprotein cholesterol (LDL-C) is a cornerstone of cardiovascular prevention, with statins forming the foundation of therapy. While PCSK-9 inhibitors\u00a0such as\u00a0evolocumab\u00a0have\u00a0demonstrated\u00a0outcome benefits in secondary prevention, their role in primary prevention,\u00a0particularly among high-risk individuals without prior myocardial infarction (MI) or stroke,\u00a0remained uncertain. The VESALIUS- CV trial showed that PCSK9 inhibition with evolocumab led [&hellip;]<\/p>\n","protected":false},"author":40613,"featured_media":139679,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"aside","meta":{"footnotes":""},"categories":[1074,8],"tags":[1075,45,47,185],"ppma_author":[1067],"class_list":{"0":"post-139678","1":"post","2":"type-post","3":"status-publish","4":"format-aside","5":"has-post-thumbnail","7":"category-acc-2026","8":"category-news","9":"tag-acc-2026","10":"tag-conference","11":"tag-featured","12":"tag-news","13":"post_format-post-format-aside","14":"author-oludamilola-aladesanmi-md"},"authors":[{"term_id":1067,"user_id":40613,"is_guest":0,"slug":"oludamilola-aladesanmi-md","display_name":"Oludamilola Aladesanmi MD","avatar_url":"https:\/\/secure.gravatar.com\/avatar\/5e6ceb579581d61ff9a0d36b0fce74899a775ad4d72a95a58d4a9e17cf8d9ac5?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\/139678","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\/40613"}],"replies":[{"embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=139678"}],"version-history":[{"count":1,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts\/139678\/revisions"}],"predecessor-version":[{"id":139680,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts\/139678\/revisions\/139680"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/media\/139679"}],"wp:attachment":[{"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=139678"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=139678"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=139678"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fppma_author&post=139678"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}