Trial reportThe New England journal of medicine2009

Fluvastatin and perioperative events in patients undergoing vascular surgery.

Olaf Schouten, Eric Boersma, Sanne E Hoeks, Robbert Benner, Hero van Urk, Marc R H M van Sambeek, Hence J M Verhagen, Nisar A Khan, Martin Dunkelgrun, Jeroen J Bax and 2 more

2 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2009. The graph read 1 number from its abstract, feeding 1 cell of the map: it supports the treatment in 1. It is linked to 2 registered trials, which are not on this map. Cited by 73 papers, 10 of them syntheses that pooled it.

1number the graph read from it
1cell of the map it votes in
73citing papers in PubMed, 10 pooled it
field-weighted citation impact
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
Death from cardiovascular causes or myocardial infarctionfluvastatin vs placebofavours the treatment · ascvd, dyslipidemiafeeds one cell of the map
HR 0.470.24 to 0.94P=0.03
Death from cardiovascular causes or myocardial infarction occurred in 12 patients (4.8%) in the fluvastatin group and 25 patients (10.1%) in the placebo group (hazard ratio, 0.47; 95% CI, 0.24 to 0.94; P=0.03).

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 0.470.24 to 0.94
HR 0.760.64 to 0.91
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.

NCT01543555 phase3completedstarted 2012, after this paper: background citation

Multicenter Randomized Controlled Trial of Loading Dose Statins for the Prevention of Cardiovascular Complications in High-Risk Non-Cardiac Surgery

Ran2012Enrolled648Registered outcomes10Posted comparisons0ConditionsAortic Aneurism, Myocardial Infarction, Peripheral Vascular DiseaseArmsAtorvastatin, Placebo
Open the trial in the graph
NCT01186289 nawithdrawnnot on this mapstarted 2010, after this paper: background citation

Statin Therapy To Limit Cognitive Dysfunction After Cardiac Surgery

TypeinterventionalSponsorDuke UniversityRan2010 to 2012Enrolled0ConditionsNeurocognitive DysfunctionArmsatorvastatin
5 · Its place in the literature

Who cites it

73 citing papers in PubMed, 10 syntheses or guidelines pooled it.

  1. Preoperative statin therapy for adults undergoing cardiac surgery.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Arquivos brasileiros de cardiologia · 2017
    Guideline
  3. Guideline
  4. Pooled it
  5. Pooled it
  6. Perioperative statin therapy for improving outcomes during and after noncardiac vascular surgery.The Cochrane database of systematic reviews · 2013 · on this map
    Pooled it
  7. Guideline
  8. Guideline
  9. Guideline
  10. Guideline
  11. Trial
  12. Trial
  13. Trial
  14. Review
  15. Review
  16. Article
  17. Article
  18. Review
  19. Observational
  20. Article

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

6 · The record

Corrections and comments

7 · Who and what money

Authors and funding

12 authors.

Olaf SchoutenDepartment of Surgery, Erasmus Medical Center, Rotterdam, The Netherlands.
Eric Boersma
Sanne E Hoeks
Robbert Benner
Hero van Urk
Marc R H M van Sambeek
Hence J M Verhagen
Nisar A Khan
Martin Dunkelgrun
Jeroen J Bax
Don Poldermans
Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography Study Group

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.

backgroundAdverse cardiac events are common after vascular surgery. We hypothesized that perioperative statin therapy would improve postoperative outcomes.

methodsIn this double-blind, placebo-controlled trial, we randomly assigned patients who had not previously been treated with a statin to receive, in addition to a beta-blocker, either 80 mg of extended-release fluvastatin or placebo once daily before undergoing vascular surgery. Lipid, interleukin-6, and C-reactive protein levels were measured at the time of randomization and before surgery. The primary end point was the occurrence of myocardial ischemia, defined as transient electrocardiographic abnormalities, release of troponin T, or both, within 30 days after surgery. The secondary end point was the composite of death from cardiovascular causes and myocardial infarction.

resultsA total of 250 patients were assigned to fluvastatin, and 247 to placebo, a median of 37 days before vascular surgery. Levels of total cholesterol, low-density lipoprotein cholesterol, interleukin-6, and C-reactive protein were significantly decreased in the fluvastatin group but were unchanged in the placebo group. Postoperative myocardial ischemia occurred in 27 patients (10.8%) in the fluvastatin group and in 47 (19.0%) in the placebo group (hazard ratio, 0.55; 95% confidence interval [CI], 0.34 to 0.88; P=0.01). Death from cardiovascular causes or myocardial infarction occurred in 12 patients (4.8%) in the fluvastatin group and 25 patients (10.1%) in the placebo group (hazard ratio, 0.47; 95% CI, 0.24 to 0.94; P=0.03). Fluvastatin therapy was not associated with a significant increase in the rate of adverse events.

conclusionsIn patients undergoing vascular surgery, perioperative fluvastatin therapy was associated with an improvement in postoperative cardiac outcome. (Current Controlled Trials number, ISRCTN83738615.)

Indexed as

Vascular Surgical ProceduresAdrenergic beta-AntagonistsCardiovascular DiseasesCholesterolC-Reactive ProteinDouble-Blind MethodElectrocardiographyFatty Acids, MonounsaturatedFluvastatinHumansHydroxymethylglutaryl-CoA Reductase InhibitorsIndolesInterleukin-6Kaplan-Meier EstimateMyocardial IschemiaPerioperative CareAdrenergic beta-AntagonistsCholesterolC-Reactive ProteinFatty Acids, MonounsaturatedFluvastatinHydroxymethylglutaryl-CoA Reductase InhibitorsIndolesInterleukin-6Troponin T

Identifiers

PMID19726772

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.