Evidence map›Paper›PMID 19474688›Full record

SynthesisAnnals of surgery2009

Bisoprolol and fluvastatin for the reduction of perioperative cardiac mortality and myocardial infarction in intermediate-risk patients undergoing noncardiovascular surgery: a randomized controlled trial (DECREASE-IV).

Martin Dunkelgrun, Eric Boersma, Olaf Schouten, Ankie W M M Koopman-van Gemert, Frans van Poorten, Jeroen J Bax, Ian R Thomson, Don Poldermans, Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography Study Group

Registry-linked trialAbstract readComparative StudyMeta-AnalysisRandomized Controlled Trial
PubMed Publisher
In one paragraph

Synthesis in Annals of surgery, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01543555 (Multicenter Randomized Controlled Trial of Loading Dose Statins for the Prevention of Cardiovascular Complications in High-Risk Non-Cardiac Surgery), which is not on this map. Cited by 51 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 13 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.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · 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
3 · Its place in the literature

Who cites it

51 citing papers in PubMed, 13 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019).Hypertension research : official journal of the Japanese Society of Hypertension · 2019
    Guideline
  4. Pooled it
  5. Arquivos brasileiros de cardiologia · 2017
    Guideline
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Guideline
  10. Pooled it
  11. Pooled it
  12. Perioperative statin therapy for improving outcomes during and after noncardiac vascular surgery.The Cochrane database of systematic reviews · 2013 · on this map
    Pooled it
  13. Guideline
  14. Trial
  15. Trial
  16. Trial
  17. Article
  18. Review
  19. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Martin DunkelgrunDepartments of Vascular Surgery, Erasmus Medical Centre, Rotterdam, the Netherlands.
Eric Boersma
Olaf Schouten
Ankie W M M Koopman-van Gemert
Frans van Poorten
Jeroen J Bax
Ian R Thomson
Don Poldermans
Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis study evaluated the effectiveness and safety of beta-blockers and statins for the prevention of perioperative cardiovascular events in intermediate-risk patients undergoing noncardiovascular surgery. SUMMARY BACKGROUND DATA: Beta-blockers and statins reduce perioperative cardiac events in high-risk patients undergoing vascular surgery by restoring the myocardial oxygen supply/demand balance and/or stabilizing coronary plaques. However, their effects in intermediate-risk patients remained ill-defined.

methodsIn this randomized open-label 2 x 2 factorial design trial 1066 intermediate cardiac risk patients were assigned to bisoprolol, fluvastatin, combination treatment, or control therapy before surgery (median: 34 days). Intermediate risk was defined by an estimated risk of perioperative cardiac death and myocardial infarction (MI) of 1% to 6%, using clinical data and type of surgery. Starting dose of bisoprolol was 2.5 mg daily, titrated to a perioperative heart rate of 50 to 70 beats per minute. Fluvastatin was prescribed in a fixed dose of 80 mg. The primary end point was the composite of 30-day cardiac death and MI. This study is registered in the ISRCTN registry and has the ID number ISRCTN47637497.

resultsPatients randomized to bisoprolol (N = 533) had a lower incidence of perioperative cardiac death and nonfatal MI than those randomized to bisoprolol-control (2.1% vs. 6.0% events; hazard ratios: 0.34; 95% confidence intervals: 0.17-0.67; P = 0.002). Patients randomized to fluvastatin experienced a lower incidence of the end point than those randomized to fluvastatin-control therapy (3.2% vs. 4.9% events; hazard ratios: 0.65; 95% confidence intervals: 0.35-1.10), but statistical significance was not reached (P = 0.17).

conclusionBisoprolol was associated with a significant reduction of 30-day cardiac death and nonfatal MI, while fluvastatin showed a trend for improved outcome.

Indexed as

Postoperative ComplicationsAdrenergic beta-AntagonistsAgedBisoprololCohort StudiesDrug Therapy, CombinationFatty Acids, MonounsaturatedFemaleFluvastatinHeart ArrestHumansHydroxymethylglutaryl-CoA Reductase InhibitorsIncidenceIndolesMaleMiddle AgedAdrenergic beta-AntagonistsBisoprololFatty Acids, MonounsaturatedFluvastatinHydroxymethylglutaryl-CoA Reductase InhibitorsIndoles

Identifiers

What OpenQuestion holds

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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 OpenQuestion graph.