{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T15:26:57Z","timestamp":1792855617170,"version":"4.5.0"},"reference-count":16,"publisher":"American Medical Association (AMA)","issue":"16","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA"],"published-print":{"date-parts":[[2026,4,28]]},"abstract":"\n Importance<\/jats:title>\n Intensive lowering of low-density lipoprotein cholesterol (LDL-C) levels with PCSK9 (proprotein convertase subtilisin\/kexin type 9) inhibitors for cardiovascular event reduction has largely been reserved for patients with significant atherosclerosis.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To investigate whether evolocumab could prevent a first major cardiovascular event (MACE) in patients without known significant atherosclerosis.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n VESALIUS-CV was a randomized, double-blind, placebo-controlled trial of evolocumab conducted across 774 sites in 33 countries and enrolling 12\u202f257 patients with no prior myocardial infarction or stroke, LDL-C level 90 mg\/dL or greater, and qualifying atherosclerosis or high-risk diabetes. This prespecified subgroup analysis examined outcomes in patients without known significant atherosclerosis (none of the following: prior arterial revascularization, arterial stenosis \u226550%, or coronary artery calcium score \u2265100 Agatston units), all of whom had diabetes. Enrollment started in June 2019 and the last patient visit was July 2025, with a median follow-up of 4.8 years.<\/jats:p>\n <\/jats:sec>\n \n Intervention<\/jats:title>\n Patients were randomized in a 1:1 ratio to subcutaneous administration of either evolocumab (140 mg every 2 weeks) or matching placebo added to optimally tolerated statin therapy.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n The dual primary end points were composites of coronary heart disease death, myocardial infarction, or ischemic stroke (3-P MACE) and 3-P MACE plus ischemia-driven arterial revascularization (4-P MACE). Secondary end points included all-cause mortality.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n 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 substudy, the median LDL-C level at 48 weeks was 52 mg\/dL in the evolocumab group vs 111 mg\/dL in the placebo group (\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001). 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];\n P<\/jats:italic>\n \u2009=\u2009.009; 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];\n P<\/jats:italic>\n \u2009=\u2009.001; 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]).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n In high-risk patients without known significant atherosclerosis and with diabetes, evolocumab reduced the risk of a first major cardiovascular event.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov Identifier\n : NCT03872401<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jama.2026.3277","type":"journal-article","created":{"date-parts":[[2026,3,28]],"date-time":"2026-03-28T21:30:19Z","timestamp":1774733419000},"page":"1400","source":"Crossref","is-referenced-by-count":26,"title":["Evolocumab to Reduce First Major Cardiovascular Events in Patients Without Known Significant Atherosclerosis and With Diabetes"],"prefix":"10.1001","volume":"335","author":[{"given":"Nicholas A.","family":"Marston","sequence":"first","affiliation":[{"name":"TIMI Study Group, Heart and Vascular Institute, Brigham and Women\u2019s Hospital, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erin A.","family":"Bohula","sequence":"additional","affiliation":[{"name":"TIMI Study Group, Heart and Vascular Institute, Brigham and Women\u2019s Hospital, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ajay K.","family":"Bhatia","sequence":"additional","affiliation":[{"name":"Amgen Inc, Thousand Oaks, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gaetano M.","family":"De Ferrari","sequence":"additional","affiliation":[{"name":"Cardiology Division, Department of Medical Sciences, University of Torino and Citt\u00e0 della Salute e della Scienza, Torino, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lawrence A.","family":"Leiter","sequence":"additional","affiliation":[{"name":"Division of Endocrinology and Metabolism, St Michael\u2019s Hospital, University of Toronto, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jose C.","family":"Nicolau","sequence":"additional","affiliation":[{"name":"Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeong-Gun","family":"Park","sequence":"additional","affiliation":[{"name":"TIMI Study Group, Heart and Vascular Institute, Brigham and Women\u2019s Hospital, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabina A.","family":"Murphy","sequence":"additional","affiliation":[{"name":"TIMI Study Group, Heart and Vascular Institute, Brigham and Women\u2019s Hospital, Boston, 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