Financiado en parte por Amgen
Evolocumab in Patients without a Previous Myocardial Infarction or Stroke
Bohula EA, Marston NA, Bhatia AK, De Ferrari GM, Leiter LA, Nicolau JC, Park JG, Kuder JF, Murphy SA, Walsh E, Wang H, Blaha V, Budaj A, Cornel JH, Goudev A, Kiss RG, Lorenzatti AJ, Parkhomenko A, Cyrille M, Paiva da Silva Lima G, Ohman EM, Giugliano RP, Sabatine MS, VESALIUS-CV Investigators
The New England journal of medicine · 92 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
- Financiado por la industria
- Empresa
- Amgen
Según 1 financiador declarado.
Publicación
- Publicado
- 2025-11-08 · N Engl J Med · vol. 394 · número 2 · págs. 117–127
- Editorial
- Massachusetts Medical Society
- Citado
- 113 citas · más que el 100% de estudios similares · 98.7× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 16 trabajos
- Acceso
- De pago
- Áreas de investigación
- Lipoproteins and Cardiovascular Health · Acute Myocardial Infarction Research · Atherosclerosis and Cardiovascular Diseases
- Palabras clave
- evolocumab, PCSK9 inhibitors, major adverse cardiovascular events, atherosclerosis, diabetes mellitus, LDL cholesterol, ischemic stroke, myocardial infarction, coronary artery disease, ischemia-driven revascularization, cardiovascular risk reduction, primary prevention, LDL-C lowering therapy, safety and tolerability, hypertriglyceridemia, hypothyroidism
- MeSH
- humans, cardiovascular diseases, coronary disease, myocardial infarction, diabetes mellitus, anticholesteremic agents, treatment outcome, injections, subcutaneous, follow-up studies, double-blind method, aged, middle aged, female, male, atherosclerosis, cholesterol, ldl, stroke, kaplan-meier estimate, antibodies, monoclonal, humanized, proprotein convertase 9, pcsk9 inhibitors
23 autores
- Erin Ann Bohula🇺🇸Brigham and Women's Hospital; Thrombolysis in Myocardial Infarction Study Group
- Nicholas Marston🇺🇸Brigham and Women's Hospital; Thrombolysis in Myocardial Infarction Study Group
- Ajay K. Bhatia🇺🇸Amgen (United States)
- Gaetano Maria De Ferrari🇮🇹Azienda Ospedaliera Citta' della Salute e della Scienza di Torino; University of Turin
- Lawrence A. Leiter🇨🇦St. Michael's Hospital; University of Toronto
- José Carlos Nicolau🇧🇷Universidade de São Paulo; Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo; Instituto do Coração - HCFMUSP
- Jeong‐Gun Park🇺🇸Brigham and Women's Hospital; Thrombolysis in Myocardial Infarction Study Group
- Julia Kuder🇺🇸Brigham and Women's Hospital; Thrombolysis in Myocardial Infarction Study Group
- Sabina A. Murphy🇺🇸Brigham and Women's Hospital; Thrombolysis in Myocardial Infarction Study Group
- Emileigh Walsh🇺🇸Amgen (United States)
- Huei Wang🇺🇸Amgen (United States)
- Vladimir Blaha🇨🇿Charles University; University Hospital Hradec Králové
- Andrzej Budaj🇵🇱Grochowski Hospital
- Jan Hein Cornel🇳🇱Radboud University Medical Center; Noordwest Ziekenhuisgroep
- Assen Goudev🇧🇬Queen Giovanna Hospital; Medical University of Sofia
- Róbert Gábor Kiss🇭🇺Semmelweis University
- Alberto J. Lorenzatti🇦🇷Instituto Médico DAMIC
- Alexander N. Parkhomenko🇺🇦National Scientific Center "M.D. Strazhesko Institute of Cardiology"
- Marcoli Cyrille🇺🇸Amgen (United States)
- Gabriel Paiva da Silva Lima🇺🇸Amgen (United States)
- E. Magnus Ohman🇺🇸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
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
The proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitor evolocumab reduces the risk of major adverse cardiovascular events (MACE) among patients with a previous myocardial infarction, stroke, or symptomatic peripheral artery disease. The effect of evolocumab on the risk of MACE among patients without a previous myocardial infarction or stroke is unknown.
Methods
We conducted an international, double-blind, randomized, placebo-controlled trial of evolocumab in patients with atherosclerosis or diabetes and without a previous myocardial infarction or stroke who had a low-density lipoprotein cholesterol level of at least 90 mg per deciliter. Patients were randomly assigned in a 1:1 ratio to receive evolocumab at a dose of 140 mg every 2 weeks or placebo. The two primary end points were a composite of death from coronary heart disease, myocardial infarction, or ischemic stroke (3-point MACE) and a composite of 3-point MACE or ischemia-driven arterial revascularization (4-point MACE).
Results
A total of 12,257 patients were randomly assigned to receive evolocumab (6129 patients) or placebo (6128) and were included in the efficacy analyses. The median age of the patients was 66 years, 43% were women, and 93% were White. The median follow-up was 4.6 years. A 3-point MACE event occurred in 336 patients (5-year Kaplan-Meier estimate, 6.2%) in the evolocumab group, as compared with 443 (8.0%) in the placebo group (hazard ratio, 0.75; 95% confidence interval [CI], 0.65 to 0.86; P<0.001). A 4-point MACE event occurred in 747 patients (5-year Kaplan-Meier estimate, 13.4%) in the evolocumab group, as compared with 907 (16.2%) in the placebo group (hazard ratio, 0.81; 95% CI, 0.73 to 0.89; P<0.001). No evidence of a between-group difference was seen in the incidence of safety events.
Conclusions
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. (Funded by Amgen; VESALIUS-CV ClinicalTrials.gov number, NCT03872401.).
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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