Financiado en parte por Amgen
Lipoprotein(a) Levels, Risk of Cardiovascular Events, and Benefit of Evolocumab: Findings From the VESALIUS-CV Trial
Monguillon V, Marston NA, Bohula EA, Park JG, Kuder JF, Murphy SA, De Ferrari GM, Leiter LA, Nicolau JC, Ebenbichler C, Sinnaeve P, Goudev A, Budaj A, Averkov O, Tokgözoğlu L, Blankstein R, Vinereanu D, Giugliano RP, Sabatine MS, O'Donoghue ML
Circulation · 2 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
- 2026-05-25 · Circulation · vol. 153 · número 25 · págs. 1960–1968
- Editorial
- Lippincott Williams & Wilkins
- Citado
- 6 citas · más que el 100% de estudios similares · 37.9× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 26 trabajos
- Acceso
- De pago
- Áreas de investigación
- Lipoproteins and Cardiovascular Health · Atherosclerosis and Cardiovascular Diseases · Acute Myocardial Infarction Research
- Palabras clave
- lipoprotein(a), evolocumab, PCSK9 inhibition, cardiovascular risk, major coronary events, myocardial infarction, ischemic stroke, atherosclerosis, LDL cholesterol, treatment benefit stratification, LDL cholesterol lowering
- MeSH
- humans, cardiovascular diseases, lipoprotein(a), anticholesteremic agents, risk factors, double-blind method, aged, middle aged, female, male, antibodies, monoclonal, humanized, biomarkers, pcsk9 inhibitors
20 autores
- Victorien Monguillon🇺🇸Brigham and Women's Hospital; Harvard University; Thrombolysis in Myocardial Infarction Study Group
- Nicholas Marston🇺🇸Brigham and Women's Hospital; Harvard University; Thrombolysis in Myocardial Infarction Study Group
- Erin Ann Bohula🇺🇸Brigham and Women's Hospital; Harvard University; Thrombolysis in Myocardial Infarction Study Group
- Jeong‐Gun Park🇺🇸Brigham and Women's Hospital; Harvard University; Thrombolysis in Myocardial Infarction Study Group
- Julia Kuder🇺🇸Brigham and Women's Hospital; Harvard University; Thrombolysis in Myocardial Infarction Study Group
- Sabina A. Murphy🇺🇸Brigham and Women's Hospital; Harvard University; Thrombolysis in Myocardial Infarction Study Group
- Gaetano M. 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
- Christoph F. Ebenbichler🇦🇹Innsbruck Medical University; Universität Innsbruck
- Peter Sinnaeve🇧🇪Universitair Ziekenhuis Leuven; KU Leuven
- Assen Goudev🇧🇬Medical University of Sofia
- Andrzej Budaj🇵🇱Grochowski Hospital
- Аверков Олег Валерьевич🇷🇺Pirogov Russian National Research Medical University
- Lale S Tokgözoğlu🇹🇷Hacettepe University
- Ron Blankstein🇺🇸Brigham and Women's Hospital; Harvard University
- Dragoş Vinereanu🇷🇴Carol Davila University of Medicine and Pharmacy
- Robert Patrick Giugliano🇺🇸Brigham and Women's Hospital; Harvard University; Thrombolysis in Myocardial Infarction Study Group
- Marc Steven Sabatine🇺🇸Brigham and Women's Hospital; Harvard University; Thrombolysis in Myocardial Infarction Study Group
- Michelle L. O’Donoghue🇺🇸Brigham and Women's Hospital; Harvard University; Thrombolysis in Myocardial Infarction Study Group
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Lp(a) (lipoprotein[a]) is a risk factor for coronary heart disease. Whether baseline Lp(a) identifies higher-risk patients who derive more benefit from evolocumab is not established in a population without previous myocardial infarction (MI) or stroke.
Methods
From June 2019 to November 2021, the VESALIUS-CV trial (Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarctions or Stroke) enrolled patients with qualifying atherosclerosis or high-risk diabetes without previous MI or stroke and randomized them to evolocumab or placebo (median follow-up 4.6 years). In a prespecified analysis, Lp(a) was assessed at baseline in 7557 patients. Cox models were used to assess the adjusted risk of cardiovascular events by baseline Lp(a) in the placebo arm, and the efficacy of evolocumab by baseline Lp(a). The primary outcome of interest was the composite of major coronary events (coronary heart disease death, MI, or urgent coronary revascularization).
Results
Median age was 66 [interquartile range, 60-71] years, and 42.8% were women; median Lp(a) was 28 [interquartile range, 9-132] nmol/L. Higher baseline Lp(a) was associated with an increased risk of major coronary events (adjusted hazard ratio [HRadjusted] per 100 nmol/L increase in Lp(a), 1.15 [95% CI, 1.05-1.26]; P=0.004), particularly for MI (HRadjusted, 1.23 [95% CI, 1.10-1.38]; Padjusted, 1.00 [95% CI, 0.84-1.19]; P=0.99). After 48 weeks, evolocumab reduced LDL-C (low-density lipoprotein cholesterol) by 66.8 mg/dL and Lp(a) by 38.0 nmol/L in patients with baseline Lp(a) >105 nmol/L versus 61.1 mg/dL and 6.0 nmol/L in those with baseline Lp(a) ≤105 nmol/L. The relative reductions in the rate of major coronary events were 41% (HR, 0.59 [95% CI, 0.41-0.83]) in those with Lp(a) >105 nmol/L compared with 35% (HR, 0.65 [95% CI, 0.51-0.82]) in those below (P-interaction=0.45 for Lp[a] modeled as continuous variable). The corresponding absolute reductions were 3.7% versus 2.5% (P-interaction=0.09), corresponding to a number needed to treat of 28 versus 40 to prevent 1 major coronary event at 5 years.
Conclusions
In patients with atherosclerosis or high-risk diabetes but without previous MI or stroke, Lp(a) was independently associated with an increased risk of major coronary events but not ischemic stroke. Evolocumab reduced the relative risk of major coronary events to a similar degree irrespective of baseline Lp(a), with a numerically greater absolute risk reduction in patients with elevated Lp(a).
Registration
URL: https://www.clinicaltrials.gov; Unique identifier: NCT03872401.
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