Evolocumab to Reduce First Major Cardiovascular Events in Patients Without Known Significant Atherosclerosis and With Diabetes: Results From the VESALIUS-CV Trial
Marston NA, Bohula EA, Bhatia AK, De Ferrari GM, Leiter LA, Nicolau JC, Park JG, Murphy SA, Walsh E, Liu L, Verma S, Sattar N, Nicholls SJ, Lopez-Sendon J, Gouni-Berthold I, Tokgozoglu L, Blankstein R, Cyrille M, da Silva Lima GP, Giugliano RP, Sabatine MS, VESALIUS-CV Investigators
JAMA · 16 citas
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2026-03-28 · JAMA · vol. 335 · número 16 · pág. 1400
- Editorial
- American Medical Association
- Citado
- 23 citas · más que el 100% de estudios similares · 145.3× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 16 trabajos
- Acceso
- Acceso abierto (copia en repositorio) · OTHER-OA
- Áreas de investigación
- Lipoproteins and Cardiovascular Health · Diabetes, Cardiovascular Risks, and Lipoproteins · Atherosclerosis and Cardiovascular Diseases
- Palabras clave
- PCSK9 inhibitors, major adverse cardiovascular events, diabetes mellitus, LDL cholesterol lowering, statin therapy, coronary artery disease, ischemic stroke, myocardial infarction, all-cause mortality, subgroup analysis, lipid-lowering therapy, cardiovascular disease prevention, arterial revascularization
- MeSH
- humans, cardiovascular diseases, coronary disease, myocardial infarction, diabetes mellitus, diabetes complications, vascular surgical procedures, injections, subcutaneous, double-blind method, aged, middle aged, female, male, atherosclerosis, cholesterol, ldl, kaplan-meier estimate, vascular grafting, antibodies, monoclonal, humanized, proprotein convertase 9, ischemic stroke, pcsk9 inhibitors
100 autores
- Nicholas Marston🇺🇸 · autor de correspondenciaBrigham and Women's Hospital; Thrombolysis in Myocardial Infarction Study Group
- Erin Ann Bohula🇺🇸Brigham and Women's Hospital; Thrombolysis in Myocardial Infarction Study Group
- Ajay K. Bhatia🇺🇸Amgen (United States)
- Gaetano M. De Ferrari🇮🇹Azienda Ospedaliera Citta' della Salute e della Scienza di Torino; University of Turin
- LA Leiter🇨🇦St. Michael's Hospital; University of Toronto
- José Carlos Nicolau🇧🇷Universidade de São Paulo; Instituto do Coração - HCFMUSP
- Jeong‐Gun Park🇺🇸Brigham and Women's Hospital; Thrombolysis in Myocardial Infarction Study Group
- S. A. Murphy🇺🇸Brigham and Women's Hospital; Thrombolysis in Myocardial Infarction Study Group
- Emileigh Walsh🇺🇸Amgen (United States)
- Lyrica Liu🇺🇸Amgen (United States)
- Subodh Verma🇨🇦St. Michael's Hospital; University of Toronto; Unity Health Toronto
- Naveed A. Sattar🇬🇧University of Glasgow
- Stephen J Nicholls🇦🇺Monash University
- Jose Luis Lopez-Sendon🇪🇸Hospital Universitario La Paz; Hospital La Paz Institute for Health Research
- Ioanna Gouni‐Berthold🇩🇪University of Cologne; University Hospital Cologne
- Lale S Tokgözoğlu🇹🇷Hacettepe University
- Ron Blankstein🇺🇸Brigham and Women's Hospital
- Marcoli Cyrille🇺🇸Amgen (United States)
- Gabriel Paiva da Silva Lima🇺🇸Amgen (United States)
- Robert Patrick Giugliano🇺🇸Brigham and Women's Hospital; Thrombolysis in Myocardial Infarction Study Group
- Marc Steven Sabatine🇺🇸Brigham and Women's Hospital; Thrombolysis in Myocardial Infarction Study Group
- VESALIUS-CV Investigators
- Alberto J. Lorenzatti
- MARCOS RAUL LITVAK BRUNO
- Ignacio J. Mackinnon
- Emilio Alaguibe
- Gustavo Giunta
- Oscar R. Montaña
- Daniel Vogel
- JORGELINA SALA
- Diego A. Besada
- Angela Romero Zarante
- Marisa L. Vico
- Tomas Smith Casabella
- Patricia del Carmen Gonzalez Colaso
- Eleonora Montenegro
- Cesar Javier Zaidman
- Maria C. de Salvo
- Eduardo Roque Perna
- CLAUDIO RODOLFO MAJUL
- RUBEN OMAR GARCIA DURAN
- MIGUEL ANGEL HOMINAL
- Sonia Hermida
- Carolina Chacón
- Andrea P. Serrano
- Juan Albisu Di Gennaro
- Walter Stoermann
- María Mansilla
- Martín Koretzky
- Leonardo P. Novaretto
- Lilia B. Schiavi
- André Domingo Oscar Orlandini
- Fernando O. Botto
- Elizabeth Gelersztein
- Eduardo Blumberg
- Stephen J Nicholls🇦🇺Monash University
- John V. Amerena
- Walter P. Abhayaratna
- Philip Roberts-Thomson
- Matthew Worthley
- C. Judkins
- Fiona Bisshop
- Alistair Begg
- David M. Colquhoun
- Karam Kostner
- Ktut Arya
- David Cross
- Andre Conradie
- JAMIE K. MORTON
- Peter Purnell
- Andrew Hamilton
- William Van Gaal
- Ali Safaa
- David S. Eccleston
- Christoph F. Ebenbichler
- Peter Fasching
- Ursula Hanusch
- Bernhard Ludvik
- Lukas Holzinger
- Christoph H. Saely
- Konstantin Alexander Krychtiuk
- Alexandra Kautzky‐Willer
- Thomas M. Stulnig
- Peter Sinnaeve
- STEPHANE G. CARLIER
- Marc De Meulemeester
- Bart Wollaert
- Andre Philippe Peeters
- Benjamin Scott
- Philippe Vanduynhoven
- Jan Verwerft
- Tom Sarens
- Luis Augusto Tavares Russo
- Celia R. Echeverria Sampaio
- Roberto R. Giraldez
- Pedro Pimentel Filho
- Joao L. Cunha Borges
- Miguel Nasser Hissa
- José Augusto Ribas Fortes
- Rodrigo Cerci
Resumen
El texto original del estudio, en el idioma en que se publicó.
Importance
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.
Objective
To investigate whether evolocumab could prevent a first major cardiovascular event (MACE) in patients without known significant atherosclerosis.
Design, setting, and participants
VESALIUS-CV was a randomized, double-blind, placebo-controlled trial of evolocumab conducted across 774 sites in 33 countries and enrolling 12 257 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 ≥50%, or coronary artery calcium score ≥100 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.
Intervention
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.
Main outcomes and measures
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.
Results
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 (P < .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]).
Conclusions and relevance
In high-risk patients without known significant atherosclerosis and with diabetes, evolocumab reduced the risk of a first major cardiovascular event.
Trial registration
ClinicalTrials.gov Identifier: NCT03872401.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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