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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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What do we know about the role of lipoprotein(a) in atherogenesis 57 years after its discovery?
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“43,46 Similar findings were also demonstrated with alirocumab as patients with Lp(a) levels at the 75th percentile (59.6 mg/dL) at baseline experienced a 25% relative risk reduction in major cardiovascular events.”
BackgroundInfluentialAdvances in targeting LDL cholesterol: PCSK9 inhibitors and beyond
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“Those with the LDL-C levels below 70 mg/dL on average demonstrated greater incremental clinical benefit with monoclonal antibodies (mAb) to PCSK9 with higher Lp(a) levels [78 – 80], suggesting benefit from a further personalized approach to lipid-lowering therapies.”
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“The study observed a significant relationship with a 15% lower risk (95% CI, 2–26%; p¼ 0.0199) per 25 nmol/L ( 10 mg/dL) reduction in Lp(a) after adjusting for the change in LDL-C (Table 1) (O’Donoghue et al. 2019).”
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“Evolocumab reduced risk of CHD death, MI, and urgent revascularization by 23 % in pts with baseline Lp (a) > median vs 7 % in those Lp(a) median [95].”
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“FOURIER revealed that evolocumab lowered Lp(a) levels by 27% from baseline and reduced the risk of coronary artery disease (CAD) death, MI, or urgent revascularization by 23% in patients with a baseline Lp(a) > 37 nmol/L (median baseline 37 nmol/L) [24, 26, 30].”
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“Recently, the FOURIER trial has demonstrated that the addition of evolocumab to background statin therapy decreases the risk of CV events in patients with established atherosclerotic CV disease, lowering LDL-C levels by at least 30% in 99% of subjects and Lp(a) levels by a median of 27% [79,80].”
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BackgroundInfluentialInsight into the Evolving Role of PCSK9
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“28%.(11) Of note, same trends were found in real-world cohorts that have reported mean Lp(a) reductions of about 20–25%.”
BackgroundLipoprotein (a)-mediated vascular calcification: population-based and in vitro studies
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Harnessing RNA Interference for Cholesterol Lowering: The Bench‐to‐Bedside Story of Inclisiran
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Ascaso, J. F., Civeira, F., Guijarro, C., López‐Miranda, J., Masana, L., Mostaza, J. M., Pedro‐Botet, J., Pintó, X., & Valdivielso, P. (2019) · Clínica e Investigación en Arteriosclerosis · doi:10.1016/j.arteri.2019.04.002 · Cited by 42
Liu, H., Guo, Y., Zhu, C., Wu, N., Gao, Y., Xu, R., Dong, Q., Qian, J., Dou, K., & Li, J. (2022) · Journal of Translational Medicine · doi:10.1186/s12967-022-03448-x · Cited by 37
Wang, Y., Zhao, X., Zhou, P., Liu, C., Chen, R., Sheng, Z., Li, J., Zhou, J., Song, L., Zhao, H., et al. (2021) · The American Journal of Cardiology · doi:10.1016/j.amjcard.2021.03.038 · Cited by 36
Surf4, cargo trafficking, lipid metabolism, and therapeutic implications
Shen, Y., Gu, H.-M., Qin, S., & Zhang, D. (2022) · Journal of Molecular Cell Biology · doi:10.1093/jmcb/mjac063 · Cited by 37
“In addition, inhibition of PCSK9 can reduce plasma levels of lipoprotein ( a ) and postprandial triglycerides ( Le May et al., 2009 ; Romagnuolo et al., 2015 ; O’Donoghue et al., 2019 ) .”
BackgroundThau, H., Neuber, S., Emmert, M. Y., & Nazari‐Shafti, T. Z. (2024) · Cardiology and Therapy · doi:10.1007/s40119-024-00353-w · Cited by 42
“In the FOURIER trial, evolo-cumab led to a 12 mg/dL reduction in Lp(a) levels, which was associated with a 15% relative risk reduction for CVD [161, 162].”
BackgroundGarwood, C. L., Cabral, K. P., Brown, R., & Dixon, D. L. (2024) · Pharmacotherapy The Journal of Human Pharmacology and Drug Therapy · doi:10.1002/phar.4635 · Cited by 45
Toth, P. P., Jones, S. R., Monsalvo, M. L., Elliott‐Davey, M., López, J. A. G., & Banach, M. (2020) · Journal of the American Heart Association · doi:10.1161/jaha.119.014129 · Cited by 36
“9%, consistent with our findings herein.(28) This analysis of FOURIER also demonstrated that higher baseline Lp(a) concentration helped to identify individuals with greater Figure 2.”
ResultBanach, M., Burchardt, P., Chlebus, K., Dobrowolski, P., Dudek, D., Dyrbuś, K., Gąsior, M., Jankowski, P., Jozwiak, J. J., Kłosiewicz−Latoszek, L., et al. (2021) · Diagnostyka Laboratoryjna · doi:10.5604/01.3001.0015.4805 · Cited by 36
Loh, W. J., Chang, X., Aw, T. C., Phua, S. K., Low, A. F.-H., Chan, M. Y., Watts, G. F., & Heng, C. (2021) · Atherosclerosis · doi:10.1016/j.atherosclerosis.2021.11.018 · Cited by 36
Sohn, W. Y., Winkle, P. J., Neutel, J., Wu, Y., Jabari, F., Terrio, C., Varrieur, T., Wang, J., & Hellawell, J. L. (2022) · Clinical Therapeutics · doi:10.1016/j.clinthera.2022.07.008 · Cited by 36
Korneva, V., Kuznetsova, T. Y., & Julius, U. (2021) · Biomedicines · doi:10.3390/biomedicines9091271 · Cited by 35
“In the FOURIER analysis the median baseline Lp(a) value was 37 nmol/L, a higher rate of major coronary events (coronary heart disease (CHD), death, MI, or urgent revascularization) in patients with higher baseline Lp(a) values was shown [19].”
BackgroundDurlach, V., Bonnefont‐Rousselot, D., Boccara, F., Varret, M., Filippo, M. D., Cariou, B., Valéro, R., Charrière, S., Farnier, M., Morange, P., et al. (2021) · Archives of cardiovascular diseases · doi:10.1016/j.acvd.2021.10.009 · Cited by 37
“Lp(a) may therefore be a predisposing factor for VTE that is particularly relevant in patients at high-risk and in combination with other thrombophilic factors [99].”
Recent Advances in Gene Therapy for Familial Hypercholesterolemia: An Update Review
Fu, Q., Hu, L., Shen, T., Yang, R., & Jiang, L. (2022) · Journal of Clinical Medicine · doi:10.3390/jcm11226773 · Cited by 41
Ward, N. C., Watts, G. F., Bishop, W., Colquhoun, D., Hamilton-Craig, C. R., Hare, D. L., Kangaharan, N., Kostner, K., Kritharides, L., O’Brien, R. C., et al. (2023) · Heart Lung and Circulation · doi:10.1016/j.hlc.2022.11.015 · Cited by 37
Therapeutic Potential of Lipoprotein(a) Inhibitors
Nicholls, S. J. (2024) · Drugs · doi:10.1007/s40265-024-02046-z · Cited by 39
“Pharmacological inhibitors of pro-protein convertase subtilisin Kexin type 9 (PCSK9) have been reported to decrease Lp(a) by 25–30%, with post hoc evidence from large clinical outcome trials that independently this is associated with their clinical benefit [42, 43].”
BackgroundQin, T., Ma, T., Huang, K., Lu, S., Zhong, J., & Li, J. (2024) · Current Atherosclerosis Reports · doi:10.1007/s11883-024-01215-5 · Cited by 36
“For patients with initial Lp(a) levels above 37 nmol/L, PCSK9 inhibitors can lower the risk of ASCVD by 23% [83].”
BackgroundPotential of Lipoprotein(a)-Lowering Strategies in Treating Coronary Artery Disease
Gencer, B., & Mach, F. (2020) · Drugs · doi:10.1007/s40265-019-01243-5 · Cited by 35
Self-citationLipoprotein (a): Recent Updates on a Unique Lipoprotein
Saeed, A., Kinoush, S., & Virani, S. S. (2021) · Current Atherosclerosis Reports · doi:10.1007/s11883-021-00940-5 · Cited by 35
Olaniyi, K. S., & Areloegbe, S. E. J. (2022) · Life Sciences · doi:10.1016/j.lfs.2022.120560 · Cited by 34
Ueng, K., Chiang, C., Chao, T., Wu, Y., Lee, W.-L., Li, Y., Ting, K.-H., Su, C.-H., Lin, H., Su, T., et al. (2023) · PubMed Central · doi:10.6515/acs.202301_39(1).20221103a · Cited by 34
Novel Pharmacological Therapies for the Management of Hyperlipoproteinemia(a)
Kosmas, C. E., Bousvarou, M. D., Papakonstantinou, E. J., Tsamoulis, D., Koulopoulos, A., Uceta, R. E., Guzman, E., & Rallidis, L. S. (2023) · International Journal of Molecular Sciences · doi:10.3390/ijms241713622 · Cited by 36
Sniderman, A. D., Pencina, M. J., & Thanassoulis, G. (2019) · Circulation Research · doi:10.1161/circresaha.119.315019 · Cited by 34
“By contrast, evidence from randomized clinical trials suggests Lp(a) adds independent information.(12,13)”
Langsted, A., & Nordestgaard, B. G. (2020) · Current Opinion in Lipidology · doi:10.1097/mol.0000000000000681 · Cited by 33
Lipoprotein (a): When to Measure and How to Treat?
Rhainds, D., Brodeur, M. R., & Tardif, J. (2021) · Current Atherosclerosis Reports · doi:10.1007/s11883-021-00951-2 · Cited by 32
A Review of the Clinical Pharmacology of Pelacarsen: A Lipoprotein(a)-Lowering Agent
Hardy, J., Niman, S., Goldfaden, R. F., Ashchi, M., Bisharat, M. B., Huston, J., Hartmann, H., & Choksi, R. R. (2021) · American Journal of Cardiovascular Drugs · doi:10.1007/s40256-021-00499-1 · Cited by 35
Youssef, A., Clark, J. R., Marcovina, S. M., Boffa, M. B., & Koschinsky, M. L. (2022) · Arteriosclerosis Thrombosis and Vascular Biology · doi:10.1161/atvbaha.121.317335 · Cited by 34
Zheng, K. H., Arsenault, B. J., Kaiser, Y., Khaw, K., Wareham, N. J., Stroes, E. S. G., & Boekholdt, S. M. (2019) · Journal of the American Heart Association · doi:10.1161/jaha.119.013020 · Cited by 32
Self-citationInteractions between PCSK9 and NLRP3 inflammasome signaling in atherosclerosis
Wang, Y., Fang, D., Yang, Q., You, J., Wang, L., Wu, J., Zeng, M., & Luo, M. (2023) · Frontiers in Immunology · doi:10.3389/fimmu.2023.1126823 · Cited by 36
Lipoprotein(a) and Atherosclerotic Cardiovascular Disease: Where Do We Stand?
Tsioulos, G., Kounatidis, D. C., Vallianou, N. G., Poulaki, A., Kotsi, E., Christodoulatos, G. S., Tsilingiris, D., Karampela, Ι., Skourtis, A., & Dalamaga, Μ. (2024) · International Journal of Molecular Sciences · doi:10.3390/ijms25063537 · Cited by 36
“These inhibitors have also been shown to decrease Lp(a) levels by 19–27%, although the exact mechanisms behind this effect are not fully understood [127,128,197].”
BackgroundMahmood, T. A., Minnier, J., Ito, M. K., Li, Q. H., Koren, A., Kam, I. W., Fazio, S., & Shapiro, M. D. (2020) · European Journal of Preventive Cardiology · doi:10.1177/2047487320915803 · Cited by 32
Self-citationGene-based therapy in lipid management: the winding road from promise to practice
Tromp, T. R., Stroes, E. S. G., & Hovingh, G. K. (2020) · Expert Opinion on Investigational Drugs · doi:10.1080/13543784.2020.1757070 · Cited by 33
Self-citationLipoprotein(a) Lowering—From Lipoprotein Apheresis to Antisense Oligonucleotide Approach
Greco, M. F., Sirtori, C. R., Corsini, A., Владиславович, Е. М., Sampietro, T., & Ruscica, M. (2020) · Journal of Clinical Medicine · doi:10.3390/jcm9072103 · Cited by 33
“Overall, the same conclusions were reached in the FOURIER trial [84].”
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Jun, J. E., Kang, H., Hwang, Y., Ahn, K. J., Chung, H.-Y., & Jeong, I. (2020) · Diabetes Research and Clinical Practice · doi:10.1016/j.diabres.2020.108622 · Cited by 31
Cao, Y., Zhang, H., Jin, J., Liu, H., Zhang, Y., Zhang, M., Gao, Y., Guo, Y., Wu, N., Zhu, C., et al. (2020) · Thrombosis and Haemostasis · doi:10.1055/a-1340-2109 · Cited by 32
Lipoprotein(a) and subclinical coronary atherosclerosis in asymptomatic individuals
Lee, H., Park, K. S., Jeon, Y., Park, E. J., Park, S., Ann, S. H., Kim, Y., Lee, Y. J., Choi, S. H., & Park, G. (2021) · Atherosclerosis · doi:10.1016/j.atherosclerosis.2021.09.027 · Cited by 32
PCSK9 Inhibitors in the Management of Cardiovascular Risk: A Practical Guidance
Jia, X., Rifai, M. A., Saeed, A., Ballantyne, C. M., & Virani, S. S. (2022) · Vascular Health and Risk Management · doi:10.2147/vhrm.s275739 · Cited by 34
Lipid management for cardiovascular risk reduction in type 1 diabetes
Tell, S., Nadeau, K. J., & Eckel, R. H. (2020) · Current Opinion in Endocrinology, Diabetes & Obesity · doi:10.1097/med.0000000000000551 · Cited by 30
Chen, Z., Shao, W., Li, Y., Zhang, X., Geng, Y., Ma, X., Tao, B., Ma, Y., Yi, C., Zhang, B., et al. (2024) · Metabolism · doi:10.1016/j.metabol.2023.155774 · Cited by 36
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Blanchard, V., Chemello, K., Hollstein, T., Chong-Hong-Fong, C., Schumann, F., Grenkowitz, T., Nativel, B., Coassin, S., Croyal, M., Kassner, U., et al. (2021) · Cardiovascular Research · doi:10.1093/cvr/cvab247 · Cited by 32
Elevated Lipoprotein(a): Background, Current Insights and Future Potential Therapies
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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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