Trial reportThe New England journal of medicine2008

Intensive lipid lowering with simvastatin and ezetimibe in aortic stenosis.

Anne B Rossebø, Terje R Pedersen, Kurt Boman, Philippe Brudi, John B Chambers, Kenneth Egstrup, Eva Gerdts, Christa Gohlke-Bärwolf, Ingar Holme, Y Antero Kesäniemi and 7 more

6 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2008. The graph read 3 numbers from its abstract, feeding 4 cells of the map: it finds no clear difference in 4. It is linked to 6 registered trials, which are not on this map. Cited by 510 papers, 10 of them syntheses that pooled it.

3numbers the graph read from it
4cells of the map it votes in
510citing papers in PubMed, 10 pooled it
81.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

← favours the treatmentfavours the comparator →
1 · no effect
Aortic-valve replacementsimvastatin-ezetimibe vs placebono clear difference · ascvd, dyslipidemiafeeds 2 cells of the map
HR 1.000.84 to 1.18P=0.97
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).
Composite of major cardiovascular eventssimvastatin-ezetimibe vs placebono clear difference · ascvd, dyslipidemiafeeds 2 cells of the map
HR 0.960.83 to 1.12
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).
Ischemic cardiovascular eventssimvastatin-ezetimibe vs placebofavours the treatment · ascvd, dyslipidemiafeeds 2 cells of the map
HR 0.780.63 to 0.97P=0.02
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.

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

Other lipid agents×cardiovascular events

InconclusiveOpen on the map →What to test next →

10 readable studies in this cell: 5 favour the treatment, 5 find no difference, 0 favour the comparator.

Belief with this paper
0.80established · 4 families support, 1 contradict · against placebo
Without it
0.80This paper does not move the number.
← favours the treatmentfavours the comparator →
1 · no effect
This paper · 2008
HR 0.960.83 to 1.12
NCT0020287818,144 enrolled · 2005
HR 0.940.89 to 0.99
NCT0061899526 enrolled · 2007
Geometric least-squares mean ratio 0.940.77 to 1.14

Statins×cardiovascular events

InconclusiveOpen on the map →What to test next →

30 readable studies in this cell: 18 favour the treatment, 11 find no difference, 1 favour the comparator.

Belief with this paper
0.86replicated · 12 families support, 2 contradict · against placebo
Without it
0.86This paper does not move the number.
← favours the treatmentfavours the comparator →
1 · no effect
This paper · 2008
HR 0.960.83 to 1.12
HR 0.710.56 to 0.90
NCT023442907,769 enrolled · 2015
HR 0.640.48 to 0.84
HR 1.781.00 to 3.17
NCT03944512102 enrolled · 2019
RR 0.670.37 to 1.19

Other lipid agents×cardiac & vascular function

InconclusiveOpen on the map →What to test next →

4 readable studies in this cell: 0 favour the treatment, 4 find no difference, 0 favour the comparator.

Belief with this paper
0.00contested · 0 families support, 3 contradict · against placebo
Without it
0.00This paper does not move the number.
← favours the treatmentfavours the comparator →
1 · no effect
This paper · 2008
HR 1.000.84 to 1.18

Statins×cardiac & vascular function

InconclusiveOpen on the map →What to test next →

11 readable studies in this cell: 4 favour the treatment, 6 find no difference, 1 favour the comparator.

Belief with this paper
0.50contested · 3 families support, 3 contradict · against placebo
Without it
0.50This paper does not move the number.
← favours the treatmentfavours the comparator →
1 · no effect
This paper · 2008
HR 1.000.84 to 1.18
4 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00092677 phase3completednot on this map

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Effects of Ezetimibe + Simvastatin on Clinical Outcomes in Patients With Aortic Stenosis

TypeinterventionalSponsorOrganon and CoRan2001 to 2008Enrolled1,873ConditionsAortic StenosisArmsezetimibe (+) simvastatin, Comparator: Placebo
NCT02679261 phase3completednot on this mapstarted 2016, after this paper: background citation

Evaluating the Effectiveness of Atorvastatin on the Progression of Aortic Dilatation and Valvular Degeneration in Patients With Bicuspid Aortic Valve (BICATOR)

TypeinterventionalSponsorHospital Universitari Vall d'Hebron Research InstituteRan2016 to 2021Enrolled220ConditionsBicuspid Aortic ValveArmsAtorvastatin, Placebo
NCT04968509 phase3recruitingnot on this mapstarted 2024, after this paper: background citation

A Randomized Trial of PCSK9 Inhibitors in Calcific Aortic Valve Stenosis

TypeinterventionalSponsorBeijing Anzhen HospitalRan2024 to 2028Enrolled160ConditionsAortic StenosisArmsPCSK9 inhibitors and statins with or without ezetimibe, Statins with or without ezetimibe
NCT05847751 active not recruitingnot on this mapstarted 2024, after this paper: background citation

The Use of ACURATE Neo 2 Valve in Patients With Symptomatic Aortic Valve Stenosis

Typeobservational_patient_registrySponsorCeric SàrlRan2024 to 2026Enrolled51ConditionsSevere Aortic Valve StenosisArmsAortic valve replacement
NCT06660524 phase4recruitingnot on this mapstarted 2024, after this paper: background citation

Clinical Study on the Influence of Calcium and Phosphorus Regulation Therapy on Valvular Heart Disease.

TypeinterventionalSponsorChina National Center for Cardiovascular DiseasesRan2024 to 2025Enrolled196ConditionsDegenerative Heart Valve Disease, Heart Valve Calcification, Chronic Kidney Disease(CKD), Calcium-Phosphorus Metabolism DisordersArmsSevelamer, Calcium carbonate
NCT07256197 phase3not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Effect and Safety of PCSK9 Inhibitors on the Progression of Mild/Middle Calcific Aortic Stenosis: A Randomized Controlled Clinical Trial

TypeinterventionalSponsorBeijing Anzhen HospitalRan2026 to 2029Enrolled160ConditionsAortic Stenosis, CalcificArmsTreatment with PCSK9 inhibitors, Treatment without PCSK9 inhibitors
5 · Its place in the literature

Who cites it

510 citing papers in PubMed, 10 syntheses or guidelines pooled it, 1,607 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Benefits and Risks of Antihyperlipidemic Medication in Adults with Different Low-Density Lipoprotein Cholesterol Based on the Number Needed to Treat.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2024 · on this map
    Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Guideline
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Article
  19. Article
  20. Article

450 more citing papers are in PubMed but not listed here.

6 · The record

Corrections and comments

7 · Who and what money

Authors and funding

17 authors at 14 institutions in 9 countries.

Anne B RossebøDivision of Cardiology, Aker University Hospital, Trondheimsveien 235, N-0514 Oslo, Norway. anne@rossebo.net
Terje R Pedersen
Kurt Boman
Philippe Brudi
John B Chambers
Kenneth Egstrup
Eva Gerdts
Christa Gohlke-Bärwolf
Ingar Holme
Y Antero Kesäniemi
William Malbecq
Christoph A Nienaber
Simon Ray
Terje Skjaerpe
Kristian Wachtell
Ronnie Willenheimer
SEAS Investigators
Akdeniz University Hospital · TRLund University · SEMerck & Co., Inc., Rahway, NJ, USA (United States) · USMSD (Belgium) · BERigshospitalet · DKSt Olav's University Hospital · NOSt. Thomas Hospital · CASvendborg Sygehus · DKUmeå University · SEUniversitäts-Herzzentrum Freiburg-Bad Krozingen · DEUniversitätsmedizin Rostock · DEUniversity of Bergen · NOUniversity of Oslo · NOUniversity of Oulu · FI

Funding

No grant is acknowledged in the PubMed record.

8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

backgroundHyperlipidemia has been suggested as a risk factor for stenosis of the aortic valve, but lipid-lowering studies have had conflicting results.

methodsWe 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.

resultsDuring 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).

conclusionsSimvastatin 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.)

Indexed as

AdultAgedAged, 80 and overAlanine TransaminaseAnticholesteremic AgentsAortic Valve StenosisAspartate AminotransferasesAzetidinesCardiovascular DiseasesCholesterol, LDLCoronary Artery BypassDisease ProgressionDouble-Blind MethodDrug Therapy, CombinationEzetimibeFemaleAlanine TransaminaseAnticholesteremic AgentsAspartate AminotransferasesAzetidinesCholesterol, LDLEzetimibeSimvastatin

Identifiers

PMID18765433
OpenAlexW2167045683

What Socratic holds

Texttitle and abstract
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.