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Lipoprotein(a), PCSK9 Inhibition, and Cardiovascular Risk: Insights From the FOURIER Trial
Open accessAbstract
Background: Lipoprotein(a) [Lp(a)] may play a causal role in atherosclerosis. PCSK9 (proprotein convertase subtilisin/kexin 9) inhibitors have been shown to significantly reduce plasma Lp(a) concentration. However, the relationship between Lp(a) levels, PCSK9 inhibition, and cardiovascular risk reduction remains undefined. Methods: Lp(a) was measured in 25 096 patients in the FOURIER trial (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk), a randomized trial of evolocumab versus placebo in patients with established atherosclerotic cardiovascular disease (median follow-up, 2.2 years). Cox models were used to assess the independent prognostic value of Lp(a) and the efficacy of evolocumab for coronary risk reduction by baseline Lp(a) concentration. Results: The median (interquartile range) baseline Lp(a) concentration was 37 (13–165) nmol/L. In the placebo arm, patients with baseline Lp(a) in the highest quartile had a higher risk of coronary heart disease death, myocardial infarction, or urgent revascularization (adjusted hazard ratio quartile 4: quartile 1, 1.22; 95% CI, 1.01–1.48) independent of low-density lipoprotein cholesterol. At 48 weeks, evolocumab significantly reduced Lp(a) by a median (interquartile range) of 26.9% (6.2%–46.7%). The percent change in Lp(a) and low-density lipoprotein cholesterol at 48 weeks in patients taking evolocumab was moderately positively correlated ( r =0.37; 95% CI, 0.36–0.39; P <0.001). Evolocumab reduced the risk of coronary heart disease death, myocardial infarction, or urgent revascularization by 23% (hazard ratio, 0.77; 95% CI, 0.67–0.88) in patients with a baseline Lp(a) >median, and by 7% (hazard ratio, 0.93; 95% CI, 0.80–1.08; P interaction=0.07) in those ≤median. Coupled with the higher baseline risk, the absolute risk reductions, and number needed to treat over 3 years were 2.49% and 40 versus 0.95% and 105, respectively. Conclusions: Higher levels of Lp(a) are associated with an increased risk of cardiovascular events in patients with established cardiovascular disease irrespective of low-density lipoprotein cholesterol. Evolocumab significantly reduced Lp(a) levels, and patients with higher baseline Lp(a) levels experienced greater absolute reductions in Lp(a) and tended to derive greater coronary benefit from PCSK9 inhibition. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01764633.
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“In the FOURIER trial, greater MACE reductions were seen among patients whose highly elevated Lp(a) levels were reduced by evolocumab [193].”
From Established and Emerging Lipid-Lowering Drugs for Primary and Secondary Cardiovascular Prevention (2023) · cites this paper as [193]
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“This finding has also been supported by randomised control trials which shown that PCSK9 inhibition with evolocumab provides modest (16%) reduction in Lp(a) levels in patients with high Lp(a) levels43.”
From Genetic insights into causal effects of lipids and lipid-modifying targets on calcific aortic valve stenosis: a Mendelian randomized study (2025) · cites this paper as [43]
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“The net effect is a muted class response, with Lp(a) typically lowering around 20 to 30%, well below the reductions seen with LDL C and ApoB [25].”
From Oral PCSK9 inhibitors for elevated LDL-C: A systematic review and meta-analysis of randomized trials (2026) · cites this paper as [25]
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“Although recent studies with PCSK9 inhibitors were not designed to target patients with high Lp(a) concentrations, they nevertheless revealed that patients with higher baseline Lp(a) concentration experienced greater absolute reductions in Lp(a) and tended to derive greater clinical benefit from PCSK9 inhibition [27,28].”
From Quantifying atherogenic lipoproteins for lipid-lowering strategies: Consensus-based recommendations from EAS and EFLM (2020) · cites this paper as [27]
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“evolocumab in the FOURIER trial reduced Lp(a) by a median of 26.9% at 48 weeks[2,25], and alirocumab in ODYSSEY OUTCOMES showed a median relative reduction of −23% by 4 months[3,26].”
From Oral PCSK9 inhibitors for elevated LDL-C: A systematic review and meta-analysis of randomized trials (2026) · cites this paper as [25]
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“In contrast, Mendelian randomization studies have consistently demonstrated that lifelong exposure to higher Lp(a) levels is strongly and causally associated with an increased risk of ASCVD [74,75].”
From 2019 ESC/EAS guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk (2019) · cites this paper as [75]
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Lipoprotein(a), Oxidized Phospholipids, and Coronary Artery Disease Severity and Outcomes
Gilliland, T., Liu, Y., Mohebi, R., Miksenas, H., Haidermota, S., Wong, M., Hu, X., Cristino, J., Browne, A., Plutzky, J., et al. (2023) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2023.02.050 · Cited by 110
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Berman, A. N., Biery, D. W., Besser, S. A., Singh, A., Shiyovich, A., Weber, B., Huck, D. M., Divakaran, S., Hainer, J. M., Kaur, G., et al. (2024) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2023.12.031 · Cited by 124
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Bhatia, H. S., Wandel, S., Willeit, P., Lesogor, A., Bailey, K., Ridker, P. M., Nestel, P. J., Simes, R. J., Tonkin, A. M., Schwartz, G. G., et al. (2024) · Circulation · doi:10.1161/circulationaha.124.069556 · Cited by 127
“9 In ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab), which compared the PCSK9i alirocumab with placebo on a background of high-intensity or maximum-tolerated statin, baseline Lp(a) quartile strongly predicted risk of…”
Lipoprotein(a) as a Pharmacological Target: Premises, Promises, and Prospects
Greco, A., Finocchiaro, S., Spagnolo, M., Faro, D. C., Mauro, M. S., Raffo, C., Sangiorgio, G., Imbesi, A., Laudani, C., Mazzone, P. M., et al. (2025) · Circulation · doi:10.1161/circulationaha.124.069210 · Cited by 126
“53,66 The greater Lp(a) lowering with these drugs in individuals with higher baseline Lp(a) seems to have a modest impact in terms of cardiovascular risk reduction, and the exact magnitude of such effects remains to be determined.”
InfluentialLu, Y., Cui, X., Zhang, L., Wang, X., Xu, Y., Qin, Z., Liu, G., Wang, Q., Tian, K., Lim, K. S., et al. (2022) · Aging and Disease · doi:10.14336/ad.2021.0929 · Cited by 117
“bococizumab and alirocumab showed improved reduction of Lp(a) compared with statins [121, 134].”
BackgroundO’Donoghue, M. L., López, J. A. G., Knüsel, B., Gencer, B., Wang, H., Wu, Y., Kassahun, H., & Sabatine, M. S. (2022) · American Heart Journal · doi:10.1016/j.ahj.2022.05.004 · Cited by 112
Self-citationEstablished and Emerging Lipid-Lowering Drugs for Primary and Secondary Cardiovascular Prevention
Michaeli, D. T., Michaeli, J. C., Albers, S., Boch, T., & Michaeli, T. (2023) · American Journal of Cardiovascular Drugs · doi:10.1007/s40256-023-00594-5 · Cited by 109
“In the FOURIER trial, greater MACE reductions were seen among patients whose highly elevated Lp(a) levels were reduced by evolocumab [193].”
BackgroundClinical Trial Design for Lipoprotein(a)-Lowering Therapies
Malick, W. A., Goonewardena, S. N., Köenig, W., & Rosenson, R. S. (2023) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2023.02.033 · Cited by 112
Lipoprotein(a) and Long-Term Cardiovascular Risk in a Multi-Ethnic Pooled Prospective Cohort
Wong, N. D., Fan, W., Hu, X., Ballantyne, C. M., Hoogeveen, R. C., Tsai, M. Y., Browne, A., & Budoff, M. J. (2024) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2024.02.031 · Cited by 118
Hagström, E., Steg, P. G., Szarek, M., Bhatt, D. L., Bittner, V. A., Danchin, N., Diaz, R., Goodman, S. G., Harrington, R. A., Jukema, J. W., et al. (2022) · Circulation · doi:10.1161/circulationaha.121.057807 · Cited by 118
“15,16 17–20 Moreover, lipid-lowering drugs reduce apoB to a lesser extent than LDL-C.”
Self-citationNovel and future lipid-modulating therapies for the prevention of cardiovascular disease
Brandts, J., & Ray, K. K. (2023) · Nature Reviews Cardiology · doi:10.1038/s41569-023-00860-8 · Cited by 109
PCSK9 Inhibition: From Current Advances to Evolving Future
Liu, C., Chen, J., Chen, H., Zhang, T., He, D., Luo, Q., Chi, J., Hong, Z., Liao, Y., Zhang, S., et al. (2022) · Cells · doi:10.3390/cells11192972 · Cited by 108
Welsh, P. I., Welsh, C. E., Celis-Morales, C. A., Brown, R., Ho, F. K. W., Ferguson, L. D., Mark, P. B., Lewsey, J., Gray, S. R., Lyall, D. M., et al. (2020) · European Journal of Preventive Cardiology · doi:10.1093/eurjpc/zwaa063 · Cited by 106
The PCSK9 revolution: Current status, controversies, and future directions
Warden, B. A., Fazio, S., & Shapiro, M. D. (2019) · Trends in Cardiovascular Medicine · doi:10.1016/j.tcm.2019.05.007 · Cited by 103
Self-citationArnold, M., Schweizer, J., Nakas, C. T., Schütz, V., Westphal, L. P., Inauen, C., Pokorny, T., Luft, A. R., Leichtle, A. B., Arnold, M., et al. (2021) · European Heart Journal · doi:10.1093/eurheartj/ehab081 · Cited by 99
Evidence of an anti-inflammatory effect of PCSK9 inhibitors within the human atherosclerotic plaque
Marfella, R., Prattichizzo, F., Sardu, C., Paolisso, P., D’Onofrio, N., Scisciola, L., Grotta, R. L., Frigé, C., Ferraraccio, F., Panarese, I., et al. (2023) · Atherosclerosis · doi:10.1016/j.atherosclerosis.2023.06.971 · Cited by 103
Lipoprotein(a)—The Crossroads of Atherosclerosis, Atherothrombosis and Inflammation
Ugovšek, S., & Šebeštjen, M. (2021) · Biomolecules · doi:10.3390/biom12010026 · Cited by 102
“Evolocumab therapy in the first of these two trials, and alirocumab therapy in the second, reduced Lp(a) levels and cardiovascular disease risk independent of LDL cholesterol lowering [31,32].”
BackgroundResultInfluentialMenopause symptom management in women with dyslipidemias: An EMAS clinical guide
Anagnostis, P. G., Bitzer, J., Cano, A., Ceauşu, I., Chedraui, P. A., Durmuşoğlu, F., Erkkola, R., Goulis, D. G., Hirschberg, A. L., Kiesel, L., et al. (2020) · Maturitas · doi:10.1016/j.maturitas.2020.03.007 · Cited by 103
Pathophysiology of Aortic Stenosis and Future Perspectives for Medical Therapy
Zheng, K. H., Tzolos, E., & Dweck, M. R. (2019) · Cardiology Clinics · doi:10.1016/j.ccl.2019.09.010 · Cited by 106
Genetic and In Vitro Inhibition of PCSK9 and Calcific Aortic Valve Stenosis
Perrot, N., Valerio, V., Moschetta, D., Boekholdt, S. M., Dina, C., Chen, H. Y., Abner, E., Martinsson, A., Manikpurage, H. D., Rigade, S., et al. (2020) · JACC: Basic to Translational Science · doi:10.1016/j.jacbts.2020.05.004 · Cited by 91
Diet and Lp(a): Does Dietary Change Modify Residual Cardiovascular Risk Conferred by Lp(a)?
Enkhmaa, B., Petersen, K. H., Kris‐Etherton, P. M., & Berglund, L. (2020) · Nutrients · doi:10.3390/nu12072024 · Cited by 98
“A post hoc analysis of the FOURIER (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk) trial demonstrated that evolocumab, a PCSK9 inhibitor, reduced Lp(a) in patients with established CVD by ~27% [70].”
BackgroundMethodLipoprotein(a) and Cardiovascular Disease in Chinese Population
Li, J., Ma, C.-S., Zhao, D. H., Yan, X.-W., Li, J., Ma, C., Zhao, D. H., Yan, X.-W., Ye, P., Chen, H., et al. (2022) · JACC Asia · doi:10.1016/j.jacasi.2022.08.015 · Cited by 96
Ray, K. K., Corral, P., Morales, E., & Nicholls, S. J. (2019) · The Lancet · doi:10.1016/s0140-6736(19)31950-6 · Cited by 94
Lipoprotein(a) and Cardiovascular Diseases ― Revisited ―
Jang, A. Y., Han, S. H., Sohn, I. S., Oh, P. C., & Koh, K. K. (2020) · Circulation Journal · doi:10.1253/circj.cj-20-0051 · Cited by 97
Nissen, S. E., Wolski, K., Watts, G. F., Koren, M. J., Fok, H., Nicholls, S. J., Rider, D. A., Cho, L., Romano, S., Melgaard, C., et al. (2024) · JAMA · doi:10.1001/jama.2024.4504 · Cited by 91
Lipoprotein apheresis for lipoprotein(a) and cardiovascular disease
Moriarty, P. M., Gray, J. V., & Gorby, L. K. (2019) · Journal of clinical lipidology · doi:10.1016/j.jacl.2019.09.010 · Cited by 89
The dedicated “Lp(a) clinic”: A concept whose time has arrived?
Tsimikas, S., & Stroes, E. S. G. (2020) · Atherosclerosis · doi:10.1016/j.atherosclerosis.2020.03.003 · Cited by 94
Self-citationPCSK9 Inhibition: Insights From Clinical Trials and Future Prospects
Katzmann, J. L., Gouni‐Berthold, I., & Laufs, U. (2020) · Frontiers in Physiology · doi:10.3389/fphys.2020.595819 · Cited by 91
Self-citationDyslipidemia Management in Adults With Diabetes
Lazarte, J., & Hegele, R. A. (2019) · Canadian Journal of Diabetes · doi:10.1016/j.jcjd.2019.07.003 · Cited by 88
Lipoprotein(a) in atherosclerosis: from pathophysiology to clinical relevance and treatment options
Likozar, A. R., Zavrtanik, M., & Šebeštjen, M. (2020) · Annals of Medicine · doi:10.1080/07853890.2020.1775287 · Cited by 91
“A post hoc analysis of the FOURIER trial also revealed an overall 16% risk reduction for major adverse cardiovascular events in patients treated with evolocumab, independent of LDL cholesterol lowering [81].”
BackgroundMethodExisting and emerging strategies to lower Lipoprotein(a)
Schwartz, G. G., & Ballantyne, C. M. (2022) · Atherosclerosis · doi:10.1016/j.atherosclerosis.2022.04.020 · Cited by 86
Highlighting Residual Atherosclerotic Cardiovascular Disease Risk
Matsuura, Y., Kanter, J. E., & Bornfeldt, K. (2018) · Arteriosclerosis Thrombosis and Vascular Biology · doi:10.1161/atvbaha.118.311999 · Cited by 88
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“3) An unknown cause of ischemic stroke.(20,97,101,104) IIb C-LD”
BackgroundInfluentialLipoprotein(a): a genetic marker for cardiovascular disease and target for emerging therapies
Cesaro, A., Schiavo, A., Moscarella, E., Coletta, S., Conte, M., Gragnano, F., Fimiani, F., Monda, E., Caiazza, M., Limongelli, G., et al. (2020) · Journal of Cardiovascular Medicine · doi:10.2459/jcm.0000000000001077 · Cited by 84
Lipoprotein(a): Knowns, unknowns and uncertainties
Ruscica, M., Sirtori, C. R., Corsini, A., Watts, G. F., & Sahebkar, A. (2021) · Pharmacological Research · doi:10.1016/j.phrs.2021.105812 · Cited by 84
Computed tomographic angiography in coronary artery disease
Serruys, P. W. J. C., Kotoku, N., Nørgaard, B. L., Garg, S., Nieman, K., Dweck, M. R., Bax, J. J., Knuuti, J. M., Narula, J., Perera, D., et al. (2023) · EuroIntervention · doi:10.4244/eij-d-22-00776 · Cited by 84
“…Elevated Risk) and ODYSSEY Outcomes (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trials showed that Lp(a) lowering by PCSK9 inhibitors was associated with a reduction in the rate of cardiovascular events in secondary prevention 69,70 .”
High lipoprotein(a): Actionable strategies for risk assessment and mitigation
Reyes‐Soffer, G., Yeang, C., Michos, E. D., Boatwright, W., & Ballantyne, C. M. (2024) · American Journal of Preventive Cardiology · doi:10.1016/j.ajpc.2024.100651 · Cited by 84
“Secondary analyses of the CV outcome trials, FOURIER and ODYS-SEY OUTCOMES, revealed that after lowering LDL-C with statins and anti-PCSK9 mAbs, high Lp(a) levels were associated with increased residual CVD risk [7,8].”
MethodAtar, D., Jukema, J. W., Molemans, B., Taub, P. R., Goto, S., Mach, F., Olmos, C. C., Underberg, J. A., KEECH, A. C., Tokgözoğlu, L. S., et al. (2021) · Atherosclerosis · doi:10.1016/j.atherosclerosis.2020.12.013 · Cited by 80
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Advances in biological therapies for dyslipidemias and atherosclerosis
Valanti, E.-K., Dalakoura-Karagkouni, K., Siasos, G., Kardassis, D., Eliopoulos, A. G., & Sanoudou, D. (2020) · Metabolism · doi:10.1016/j.metabol.2020.154461 · Cited by 68
Inclisiran: a novel agent for lowering apolipoprotein B–containing lipoproteins
Warden, B. A., & Duell, P. B. (2021) · Journal of Cardiovascular Pharmacology · doi:10.1097/fjc.0000000000001053 · Cited by 62
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“C) which also enables correction of LDL-cholesterol (LDL-C) as standard methods for measuring LDL-C also include Lp(a)-”
BackgroundInfluentialFarmakis, I. T., Doundoulakis, I., Pagiantza, A., Zafeiropoulos, S., Antza, C., Karvounis, H. I., & Giannakoulas, G. A. (2020) · Journal of Cardiovascular Pharmacology · doi:10.1097/fjc.0000000000000963 · Cited by 64
Metadata
- Authors
- O’Donoghue, M. L., Fazio, S., Giugliano, R. P., Stroes, E. S. G., Kanevsky, E., Gouni-Berthold, I., Im, K., Lira Pineda, A., Wasserman, S. M., Češka, R., Ezhov, M. V., Jukema, J. W., Jensen, H. K., Tokgözoğlu, S. L., Mach, F., Huber, K., Sever, P. S., Keech, A. C., Pedersen, T. R., & Sabatine, M. S.
- Affiliations
- Brigham and Women's Hospital (US)
- Oregon Health & Science University (US)
- Amsterdam UMC Location University of Amsterdam (NL)
- Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Germany (I.G.-B.).
- Amgen, Thousand Oaks, CA (A.L.P., S.M.W.).
- Amgen (United States) (US)
- Charles University (CZ)
- National Cardiology Research Center, Moscow, Russia (M.V.E.).
- Leiden University Medical Center (NL)
- Aarhus University (DK)
- Cardiovascular Division, Hacettepe University, Ankara, Turkey (S.L.T.).
- University of Geneva (CH)
- Sigmund Freud Privatuniversität Wien (AT)
- Imperial College London (GB)
- The University of Sydney (AU)
- Oslo University Hospital (NO)
- ORCID
- Venue
- Circulation
- Published
- 2019-03-19
- Volume
- 139
- Issue
- 12
- Pages
- 1483-1492
- ISSN
- 0009-7322 (ISSN-L)
- 1524-4539
- OpenAlex
- W2940327706
- Cited by
- 984
- References
- 33
- Citations by year
- 2026: 133 · 2025: 153 · 2024: 157 · 2023: 134 · 2022: 120 · 2021: 100 · 2020: 122 · 2019: 64
- FWCI
- 97.10
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Circulation (publishedVersion)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (publishedVersion, cc-by)
- Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Leiden Repository (Leiden University) (submittedVersion)
- Spiral (Imperial College London) (submittedVersion)
- Funders
- Abbott Laboratories
- Amgen
- Bristol-Myers Squibb
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Sanofi
- Brigham and Women's Hospital
- Gilead Sciences
- Alnylam Pharmaceuticals
- Univerzita Karlova v Praze
- Aarhus Universitet
- Aarhus Universitetshospital
- Regeneron Pharmaceuticals
- Intarcia Therapeutics
- Amarin Corporation
- Medicines Company
- Mylan
- MyoKardia
- Imperial College London
- Universiteit Leiden
- Daiichi-Sankyo
- Eisai
- Novo Nordisk
- Leids Universitair Medisch Centrum
- Universitetet i Oslo
- Hacettepe Üniversitesi
- Université de Genève
- Universität zu Köln
- Novo Nordisk Fonden (NNF18OC0031258)
- Servier
- Esperion Therapeutics
- Medical Research Council
- National Health and Medical Research Council
- Sydney Medical School
- Janssen Research and Development
- Daiichi Sankyo Europe
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipoproteins and Cardiovascular Health
- Life Sciences › Immunology and Microbiology › Immunology › Atherosclerosis and Cardiovascular Diseases
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipid metabolism and disorders
- Keywords
- lipoprotein(a), PCSK9 inhibitors, evolocumab, cardiovascular risk, atherosclerotic cardiovascular disease, coronary artery disease, myocardial infarction, urgent revascularization, LDL cholesterol, prognostic factors, FOURIER trial, LDL cholesterol lowering
- MeSH terms
- Proprotein Convertase 9, Adult, Aged, Aged, 80 and over, Anticholesteremic Agents, Double-Blind Method, Female, Humans, Cholesterol, LDL, Male, Middle Aged, Risk Factors, Placebo Effect, Proportional Hazards Models, Treatment Outcome, Lipoprotein(a), Atherosclerosis, Antibodies, Monoclonal, Humanized
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