Intensive Lipid Lowering with Simvastatin and Ezetimibe in Aortic Stenosis
Open accessAbstract
BACKGROUND: Hyperlipidemia has been suggested as a risk factor for stenosis of the aortic valve, but lipid-lowering studies have had conflicting results. METHODS: We conducted a randomized, double-blind trial involving 1873 patients with mild-to-moderate, asymptomatic aortic stenosis. The patients received either 40 mg of simvastatin plus 10 mg of ezetimibe or placebo daily. The primary outcome was a composite of major cardiovascular events, including death from cardiovascular causes, aortic-valve replacement, nonfatal myocardial infarction, hospitalization for unstable angina pectoris, heart failure, coronary-artery bypass grafting, percutaneous coronary intervention, and nonhemorrhagic stroke. Secondary outcomes were events related to aortic-valve stenosis and ischemic cardiovascular events. RESULTS: During a median follow-up of 52.2 months, the primary outcome occurred in 333 patients (35.3%) in the simvastatin-ezetimibe group and in 355 patients (38.2%) in the placebo group (hazard ratio in the simvastatin-ezetimibe group, 0.96; 95% confidence interval [CI], 0.83 to 1.12; P=0.59). Aortic-valve replacement was performed in 267 patients (28.3%) in the simvastatin-ezetimibe group and in 278 patients (29.9%) in the placebo group (hazard ratio, 1.00; 95% CI, 0.84 to 1.18; P=0.97). Fewer patients had ischemic cardiovascular events in the simvastatin-ezetimibe group (148 patients) than in the placebo group (187 patients) (hazard ratio, 0.78; 95% CI, 0.63 to 0.97; P=0.02), mainly because of the smaller number of patients who underwent coronary-artery bypass grafting. Cancer occurred more frequently in the simvastatin-ezetimibe group (105 vs. 70, P=0.01). CONCLUSIONS: Simvastatin and ezetimibe did not reduce the composite outcome of combined aortic-valve events and ischemic events in patients with aortic stenosis. Such therapy reduced the incidence of ischemic cardiovascular events but not events related to aortic-valve stenosis. (ClinicalTrials.gov number, NCT00092677.)
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Several clinical trials evaluating statin therapy in mild to moderate aortic stenosis failed to demonstrate efficacy in lipid lowering as a strategy to mitigate adverse events.
“Several clinical trials evaluating statin therapy in mild to moderate AS failed to demonstrate efficacy in lipid lowering as a strategy to mitigate adverse events in the disease39–41.”
From Genomic and transcriptomic analyses of aortic stenosis enhance therapeutic target discovery and disease prediction (2026) · cites this paper as [40]
The Discussion (page unavailable) reports that intensive lipid lowering had no overall effect on aortic stenosis or the primary composite outcome, consistent with another trial's negative finding. But the Outcome Measures and Discussion report fewer ischemic cardiovascular events with treatment, especially fewer CABG procedures, so the broader claim that lipid lowering failed to mitigate adverse events is overstated. (LLM, conf=0.86)
Experimental — accuracy not yet measuredSimvastatin combined with ezetimibe reduced ischaemic cardiovascular events in patients with mild to moderate aortic stenosis.
“However, the combination of simvastatin (drug that lowers plasma LDL cholesterol levels) and ezetimibe (drug that decreases cholesterol absorption in the small intestine) did reduce ischaemic cardiovascular events in patients with mild to moderate AS153.”
From Calcific aortic stenosis (2016) · cites this paper as [153]
Randomized trials have shown no effect of statins on haemodynamic progression or aortic stenosis-related clinical events.
“several randomized trials showed no effect of statins on haemodynamic progression or AS-related clinical events152–154.”
From Calcific aortic stenosis (2016) · cites this paper as [153]
Three randomized clinical trials failed to show significant benefit of LDL lowering with statins on AS progression.
“However, three randomized clinical trials (RCTs) failed to demonstrate any significant benefit of LDL lowering with statins on the progression of AS152–154.”
From Calcific aortic stenosis (2016) · cites this paper as [153]
Several intervention studies tested whether lipid lowering with statins would slow aortic stenosis progression, but the results were generally disappointing.
“Several intervention studies have been performed to test the hypothesis that lipid lowering with statin medications would slow the progression of AS, however the results were generally disappointing152–154.”
From Calcific aortic stenosis (2016) · cites this paper as [153]
The SHARP and SEAS trials highlight ezetimibe's role in the prevention of ischaemic cardiovascular events.
“the SHARP and SEAS trials highlight ezetimibe’s role in the prevention of ischaemic cardiovascular events [62–65].”
From Established and Emerging Lipid-Lowering Drugs for Primary and Secondary Cardiovascular Prevention (2023) · cites this paper as [63]
Randomized controlled trials failed to demonstrate any benefit of statin therapy on retarding CAVS disease progression.
“randomized controlled trials (RCTs) failed to demonstrate any benefit of statin therapy on retard disease progression6–8.”
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 [7]
The ENHANCE trial could not confirm that an addition of ezetimibe to statins significantly reduces intima-media thickness in patients with familial hypercholesterolemia.
“Although the earlier ENHANCE trial could not confirm that an addition of ezetimibe to statins significantly reduces intima-media thickness in patients with familial hypercholesterolemia, the SHARP and SEAS trials highlight ezetimibe’s role in the prevention of ischaemic cardiovascular events [62–65].”
From Established and Emerging Lipid-Lowering Drugs for Primary and Secondary Cardiovascular Prevention (2023) · cites this paper as [63]
The Patient Population and Outcome Measures sections describe the SEAS trial in people with aortic-valve stenosis, not the ENHANCE trial. A search of our copy for ENHANCE, familial hypercholesterolemia, and intima-media thickness found no passage addressing the quoted claim. The paper does report fewer ischemic cardiovascular events with simvastatin–ezetimibe, which supports the separate SEAS portion of the citing sentence. (LLM, conf=0.76)
Experimental — accuracy not yet measuredThree randomized controlled trials of lipid-lowering therapy to delay AS progression all reported no significant benefit.
“lipid-lowering therapy to delay progression of AS has been evaluated in 3 randomized controlled trials; however, all trials reported no significant benefit.[12][13][14]”
From Rare Genetic Variants in <i>LDLR</i> , <i>APOB</i> , and <i>PCSK9</i> Are Associated With Aortic Stenosis (2024) · cites this paper as [14]
The SEAS trial (1873 patients) testing simvastatin and ezetimibe in advanced AS (mean peak velocity ≈3.1±0.55 m/s) did not show a significant reduction in AS progression or AVR rate.
“Similarly, the larger SEAS trial (Simvastatin and Ezetimibe in Aortic Stenosis; 1873 patients) that tested simvastatin and ezetimibe in patients with advanced AS (mean peak velocity, ≈3.1±0.55 m/s) did not demonstrate a significant reduction in AS progression or the rate of AVR. 14”
From Rare Genetic Variants in <i>LDLR</i> , <i>APOB</i> , and <i>PCSK9</i> Are Associated With Aortic Stenosis (2024) · cites this paper as [14]
The clinical trials aimed to halt progression of established AS.
“All of the clinical trials aimed to halt the progression of established AS.”
From Rare Genetic Variants in <i>LDLR</i> , <i>APOB</i> , and <i>PCSK9</i> Are Associated With Aortic Stenosis (2024) · cites this paper as [14]
The authors addressed potential bias by observing similar associations with AVR as a strict procedural outcome.
“Second, we observed similar associations with AVR as a strict procedural outcome, which is particularly meaningful in the context of previous neutral clinical trials of lipid-lowering therapies that used AVR as the study end point.[12][13][14]”
From Rare Genetic Variants in <i>LDLR</i> , <i>APOB</i> , and <i>PCSK9</i> Are Associated With Aortic Stenosis (2024) · cites this paper as [14]
The diabetes effect is probably related to statin mechanism, as Mendelian randomization studies have confirmed increased diabetes risk in individuals with HMG-CoA reductase polymorphisms that reduce cholesterol synthesis.
“This effect is probably related to the mechanism of action of statins, as Mendelian randomization studies have confirmed the increased risk of DM in individuals with HMG-CoA reductase polymorphisms that reduce cholesterol synthesis [250].”
From 2019 ESC/EAS guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk (2019) · cites this paper as [250]
In SEAS, ezetimibe plus simvastatin in asymptomatic aortic stenosis reduced ischaemic cardiovascular events-by up to 46% in less severe aortic stenosis-but not aortic valve stenosis events.
“The results of the SEAS study in patients with asymptomatic aortic stenosis showed that ezetimibe and simvastatin applied concomitantly reduce the incidence of ischaemic CVD events (up to 46% in the patients with less severe aortic stenosis) but not events related to aortic valve stenosis.38”
From ESC/EAS Guidelines for the management of dyslipidaemias (2011) · cites this paper as [38]
In the SEAS trial, ischaemic events were reduced by 21%.
“Ischaemic events were reduced by 21%.”
From ESC/EAS Guidelines for the management of dyslipidaemias (2011) · cites this paper as [38]
In the SEAS trial, despite 61% LDL-C lowering, progression of aortic stenosis was similar between simvastatin plus ezetimibe and simvastatin alone.
“Despite marked LDL-C lowering (61%), progression of aortic stenosis was similar in the two treatment groups.38”
From ESC/EAS Guidelines for the management of dyslipidaemias (2011) · cites this paper as [38]
A recent RCT did not confirm that lipid lowering slows aortic stenosis progression, but CAD was significantly reduced.
“This was not confirmed in a recent RCT, yet the CAD was significantly reduced.38”
From ESC/EAS Guidelines for the management of dyslipidaemias (2011) · cites this paper as [38]
In the SEAS and SHARP trials, the simvastatin-ezetimibe arm showed a reduction in CV events compared to placebo.
“In both the SEAS and SHARP trials, a reduction in CV events was demonstrated in the simvastatin-ezetimibe arm vs. placebo.”
From 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias (2016) · cites this paper as [243]
Early observational noncontrolled trials suggested aggressive lipid lowering slowed progression of aortic stenosis, but this was not confirmed in RCTs.
“Suggestions for an association between aortic stenosis, LDL-C and Lp(a), as well as between cholesterol and increased risk for calcification of bioprosthetic valves, were matched with early observational noncontrolled trials that showed beneficial effects of aggressive lipid lowering in slowing the progression of aortic stenosis. However, this was not confirmed in RCTs. 243,377,378”
From 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias (2016) · cites this paper as [243]
In both the SEAS and SHARP trials, a reduction in cardiovascular events was demonstrated in the simvastatin-ezetimibe arm versus placebo.
“In both the SEAS and SHARP trials, a reduction in CV events was demonstrated in the simvastatineezetimibe arm vs. placebo.243,244”
From 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias (2016) · cites this paper as [243]
In the SEAS trial, ischaemic events were reduced by 21%.
“Notably, ischaemic events were reduced by 21% in the SEAS trial.”
From 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias (2016) · cites this paper as [243]
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Effects of the coronary artery disease associated LPA and 9p21 loci on risk of aortic valve stenosis
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Small, A. M., Yang, T.-Y., Itoh, S., Thériault, S., Dufresne, L., Kurosawa, R., Komuro, I., Matsuda, K., Vy, H. M. T., Farber-Eger, E. H., et al. (2026) · Nature Genetics · doi:10.1038/s41588-025-02417-6 · Cited by 12 · see citing works
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- Authors
- Rossebø, A. B., Pedersen, T. R., Boman, K., Brudi, P., Chambers, J. B., Egstrup, K., Gerdts, E., Gohlke-Bärwolf, C., Holme, I., Kesäniemi, Y. A., Malbecq, W., Nienaber, C. A., Ray, S., Skjærpe, T., Wachtell, K., & Willenheimer, R.
- Affiliations
- University of Oslo (NO)
- Umeå University (SE)
- Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
- Svendborg Sygehus (DK)
- Haukeland University Hospital (NO)
- Universitäts-Herzzentrum Freiburg-Bad Krozingen (DE)
- University of Oulu (FI)
- MSD (Belgium) (BE)
- Universitätsmedizin Rostock (DE)
- St Olav's University Hospital (NO)
- Rigshospitalet (DK)
- Lund University (SE)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2008-09-25
- Volume
- 359
- Issue
- 13
- Pages
- 1343-1356
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2167045683
- Semantic Scholar
- 17d4be70c41b37c9911ecea1af0967a762436d86
- Cited by
- 1,644
- References
- 44
- Citations by year
- 2026: 60 · 2025: 66 · 2024: 71 · 2023: 57 · 2022: 68 · 2021: 65 · 2020: 95 · 2019: 79 · 2018: 66 · 2017: 77 · 2016: 90 · 2015: 98 · 2014: 106 · 2013: 108 · 2012: 115
- FWCI
- 146.15
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Research Explorer (The University of Manchester) (publishedVersion)
- University of Southern Denmark Research Portal (University of Southern Denmark) (publishedVersion)
- Dépôt institutionnel de l'Université libre de Bruxelles (Université Libre de Bruxelles) (submittedVersion)
- Lund University Publications (Lund University) (submittedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (submittedVersion)
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Valve Diseases and Treatments
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
- Keywords
- aortic stenosis, simvastatin, ezetimibe, intensive lipid lowering, hyperlipidemia, aortic valve replacement, ischemic cardiovascular events, coronary artery bypass grafting, cancer risk, statins, asymptomatic aortic stenosis, cardiovascular mortality, heart failure, stroke, myocardial infarction, unstable angina
- MeSH terms
- Ezetimibe, Adult, Aged, Aged, 80 and over, Alanine Transaminase, Anticholesteremic Agents, Aortic Valve Stenosis, Coronary Artery Bypass, Aspartate Aminotransferases, Azetidines, Cardiovascular Diseases, Double-Blind Method, Drug Therapy, Combination, Female, Follow-Up Studies, Humans, Cholesterol, LDL, Male, Neoplasms, Treatment Outcome, Disease Progression, Simvastatin, Heart Valve Prosthesis Implantation, Kaplan-Meier Estimate
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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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