Trial reportThe New England journal of medicine2009

A randomized trial of rosuvastatin in the prevention of venous thromboembolism.

Robert J Glynn, Eleanor Danielson, Francisco A H Fonseca, Jacques Genest, Antonio M Gotto, John J P Kastelein, Wolfgang Koenig, Peter Libby, Alberto J Lorenzatti, Jean G MacFadyen and 4 more

3 registry-linked trialsOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The New England journal of medicine, 2009. The graph read 5 numbers from its abstract, feeding 1 cell of the map: it supports the treatment in 1. It is linked to 3 registered trials, which are not on this map. Cited by 250 papers, 10 of them syntheses that pooled it.

5numbers the graph read from it
1cell of the map it votes in
250citing papers in PubMed, 10 pooled it
63.3field-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 →
0.250.51 · no effect
Deep-vein thrombosis onlyrosuvastatin, 20 mg per day vs placebofavours the treatment · ascvd, dyslipidemiafeeds one cell of the map
HR 0.450.25 to 0.79P=0.004
The rates of pulmonary embolism were 0.09 in the rosuvastatin group and 0.12 in the placebo group (hazard ratio, 0.77; 95% CI, 0.41 to 1.45; P=0.42), whereas the rates of deep-vein thrombosis only were 0.09 and 0.20, respectively (hazard ratio, 0.45; 95% CI, 0.25 to 0.79; P=0.004).
Symptomatic venous thromboembolismrosuvastatin, 20 mg per day vs placebofavours the treatment · ascvd, dyslipidemiafeeds one cell of the map
HR 0.570.37 to 0.860.007
The rates of venous thromboembolism were 0.18 and 0.32 event per 100 person-years of follow-up in the rosuvastatin and placebo groups, respectively (hazard ratio with rosuvastatin, 0.57; 95% confidence interval [CI], 0.37 to 0.86; P=0.007); the corresponding rates for unprovoked venous thromboembolism (i.e., occurring in the absence of a known malignant condition, trauma, hospitalization, or surgery) were 0.10 and 0.17 (hazard ratio, 0.61; 95% CI, 0.35 to 1.09; P=0.09) and for provoked venous thromboembolism (i.e., occurring in patients with cancer or during or shortly after trauma, hospitalization, or surgery), 0.08 and 0.16 (hazard ratio, 0.52; 95% CI, 0.28 to 0.96; P=0.03).
Unprovoked venous thromboembolismrosuvastatin, 20 mg per day vs placebono clear difference · ascvd, dyslipidemiafeeds one cell of the map
HR 0.610.35 to 1.09P=0.09
The rates of venous thromboembolism were 0.18 and 0.32 event per 100 person-years of follow-up in the rosuvastatin and placebo groups, respectively (hazard ratio with rosuvastatin, 0.57; 95% confidence interval [CI], 0.37 to 0.86; P=0.007); the corresponding rates for unprovoked venous thromboembolism (i.e., occurring in the absence of a known malignant condition, trauma, hospitalization, or surgery) were 0.10 and 0.17 (hazard ratio, 0.61; 95% CI, 0.35 to 1.09; P=0.09) and for provoked venous thromboembolism (i.e., occurring in patients with cancer or during or shortly after trauma, hospitalization, or surgery), 0.08 and 0.16 (hazard ratio, 0.52; 95% CI, 0.28 to 0.96; P=0.03).
Provoked venous thromboembolismrosuvastatin, 20 mg per day vs placebofavours the treatment · ascvd, dyslipidemiafeeds one cell of the map
HR 0.520.28 to 0.96P=0.03
The rates of venous thromboembolism were 0.18 and 0.32 event per 100 person-years of follow-up in the rosuvastatin and placebo groups, respectively (hazard ratio with rosuvastatin, 0.57; 95% confidence interval [CI], 0.37 to 0.86; P=0.007); the corresponding rates for unprovoked venous thromboembolism (i.e., occurring in the absence of a known malignant condition, trauma, hospitalization, or surgery) were 0.10 and 0.17 (hazard ratio, 0.61; 95% CI, 0.35 to 1.09; P=0.09) and for provoked venous thromboembolism (i.e., occurring in patients with cancer or during or shortly after trauma, hospitalization, or surgery), 0.08 and 0.16 (hazard ratio, 0.52; 95% CI, 0.28 to 0.96; P=0.03).
Pulmonary embolismrosuvastatin, 20 mg per day vs placebono clear difference · ascvd, dyslipidemiafeeds one cell of the map
HR 0.770.41 to 1.45P=0.42
The rates of pulmonary embolism were 0.09 in the rosuvastatin group and 0.12 in the placebo group (hazard ratio, 0.77; 95% CI, 0.41 to 1.45; P=0.42), whereas the rates of deep-vein thrombosis only were 0.09 and 0.20, respectively (hazard ratio, 0.45; 95% CI, 0.25 to 0.79; P=0.004).

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.

Statins×cardiovascular events

SupportsOpen 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
0.85This paper moves it by +0.01.
← favours the treatmentfavours the comparator →
1 · no effect
This paper · 2009
HR 0.450.25 to 0.79
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
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.

NCT02428374 phase4unknown statusstarted 2015, after this paper: background citation

Role of Innate and Adaptive Immunity After Acute Myocardial Infarction BATTLE-AMI Study (B And T Types of Lymphocytes Evaluation in Acute Myocardial Infarction)

Ran2015Enrolled300Registered outcomes30Posted comparisons0ConditionsMyocardial FibrosisArmsRosuvastatin plus clopidogrel, Rosuvastatin plus ticagrelor, Simvastatin plus clopidogrel, Simvastatin plus ticagrelor
Open the trial in the graph
NCT00239681 phase3terminatednot on this map

A Randomized, Double-Blind, Placebo Controlled, Multicenter, Phase 3 Study of Rosuvastatin (CRESTOR®) 20 mg in the Prevention of Cardiovascular Events Among Subjects With Low Levels of Low Density Lipoprotein(LDL) Cholesterol & Elevated Levels of C-Reactive Protein

TypeinterventionalSponsorAstraZenecaRan2003 to 2008Enrolled17,802ConditionsElevated High-sensitivity C-Reactive Protein (hsCRP)ArmsRosuvastatin, Placebo
NCT04895059 phase1completednot on this mapstarted 2017, after this paper: background citation

Study of no Pharmacokinetic Interaction Between Rosuvastatin 20 mg and Ezetimibe 10 mg, Open Design, Randomized, Single Dose, 3x6, Crossove, Healthy Volunteers in Fasting, in Fixed Combination Against Individuals Components Managed

TypeinterventionalSponsorLaboratorios Silanes S.A. de C.V.Ran2017 to 2018Enrolled36ConditionsHealthyArmsRosuvastatin (20mg) /Ezetimibe (10mg) in fixed dose, Rosuvastatin 20mg, Ezetimibe 10mg
5 · Its place in the literature

Who cites it

250 citing papers in PubMed, 10 syntheses or guidelines pooled it, 744 citations in OpenAlex.

  1. Statins for the primary prevention of venous thromboembolism.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Statins for primary prevention of venous thromboembolism.The Cochrane database of systematic reviews · 2014
    Pooled it
  8. Statins for the primary prevention of cardiovascular disease.The Cochrane database of systematic reviews · 2013 · on this map
    Pooled it
  9. Statins, inflammation and deep vein thrombosis: a systematic review.Journal of thrombosis and thrombolysis · 2012
    Pooled it
  10. Guideline
  11. Trial
  12. Trial
  13. Efficacy of Atorvastatin Against Venous Thromboembolism After Total Hip Arthroplasty.Journal of musculoskeletal & neuronal interactions · 2025
    Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Trial
  20. Statin use decreases coagulation in users of vitamin K antagonists.European journal of clinical pharmacology · 2016
    Trial

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

6 · The record

Corrections and comments

7 · Who and what money

Authors and funding

14 authors at 10 institutions in 8 countries.

Robert J GlynnDivision of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02215, USA. rglynn@rics.bwh.harvard.edu
Eleanor Danielson
Francisco A H Fonseca
Jacques Genest
Antonio M Gotto
John J P Kastelein
Wolfgang Koenig
Peter Libby
Alberto J Lorenzatti
Jean G MacFadyen
Børge G Nordestgaard
James Shepherd
James T Willerson
Paul M Ridker
Brigham and Women's Hospital · USHarvard University · USMcGill University Health Centre · CAServicio Diabetología Hospital Córdoba · ARSt. Luke's Episcopal Hospital · USUniversidade Federal de São Paulo · BRUniversität Ulm · DEUniversity of Amsterdam · NLUniversity of Copenhagen · DKUniversity of Glasgow · GB

Funding

NIA NIH HHS AG031061NIA NIH HHS R01 AG031061
8 · The paper itself

Abstract

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

backgroundControversy persists regarding the extent of shared pathways between arterial and venous thrombosis and whether treatments of known efficacy for one disease process have consistent benefits for the other. Observational studies have yielded variable estimates of the effect of statin therapy on the risk of venous thromboembolism, and evidence from randomized trials is lacking.

methodsWe randomly assigned 17,802 apparently healthy men and women with both low-density lipoprotein (LDL) cholesterol levels of less than 130 mg per deciliter (3.4 mmol per liter) and high-sensitivity C-reactive protein levels of 2.0 mg per liter or higher to receive rosuvastatin, 20 mg per day, or placebo. We followed participants for the first occurrence of pulmonary embolism or deep-vein thrombosis and performed analyses of the data on an intention-to-treat basis.

resultsDuring a median follow-up period of 1.9 years (maximum, 5.0), symptomatic venous thromboembolism occurred in 94 participants: 34 in the rosuvastatin group and 60 in the placebo group. The rates of venous thromboembolism were 0.18 and 0.32 event per 100 person-years of follow-up in the rosuvastatin and placebo groups, respectively (hazard ratio with rosuvastatin, 0.57; 95% confidence interval [CI], 0.37 to 0.86; P=0.007); the corresponding rates for unprovoked venous thromboembolism (i.e., occurring in the absence of a known malignant condition, trauma, hospitalization, or surgery) were 0.10 and 0.17 (hazard ratio, 0.61; 95% CI, 0.35 to 1.09; P=0.09) and for provoked venous thromboembolism (i.e., occurring in patients with cancer or during or shortly after trauma, hospitalization, or surgery), 0.08 and 0.16 (hazard ratio, 0.52; 95% CI, 0.28 to 0.96; P=0.03). The rates of pulmonary embolism were 0.09 in the rosuvastatin group and 0.12 in the placebo group (hazard ratio, 0.77; 95% CI, 0.41 to 1.45; P=0.42), whereas the rates of deep-vein thrombosis only were 0.09 and 0.20, respectively (hazard ratio, 0.45; 95% CI, 0.25 to 0.79; P=0.004). Consistent effects were observed in all the subgroups examined. No significant differences were seen between treatment groups in the rates of bleeding episodes.

conclusionsIn this trial of apparently healthy persons, rosuvastatin significantly reduced the occurrence of symptomatic venous thromboembolism. (ClinicalTrials.gov number, NCT00239681.)

Indexed as

AgedCardiovascular DiseasesCholesterol, LDLC-Reactive ProteinDouble-Blind MethodFemaleFluorobenzenesHemorrhageHumansHydroxymethylglutaryl-CoA Reductase InhibitorsIncidenceMaleMiddle AgedPulmonary EmbolismPyrimidinesRiskCholesterol, LDLC-Reactive ProteinFluorobenzenesHydroxymethylglutaryl-CoA Reductase InhibitorsPyrimidinesRosuvastatin CalciumSulfonamides

Identifiers

PMID19329822
PMCPMC2710995
OpenAlexW1593008417

What Socratic holds

Texttitle and abstract
LicenceTDM
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.