Document Detail

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).
MedLine Citation:
PMID:  19474688     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: This 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. METHODS: In 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. RESULTS: Patients 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). CONCLUSION: Bisoprolol was associated with a significant reduction of 30-day cardiac death and nonfatal MI, while fluvastatin showed a trend for improved outcome.
Martin Dunkelgrun; Eric Boersma; Olaf Schouten; Ankie W M M Koopman-van Gemert; Frans van Poorten; Jeroen J Bax; Ian R Thomson; Don Poldermans;
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Publication Detail:
Type:  Comparative Study; Journal Article; Meta-Analysis; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Annals of surgery     Volume:  249     ISSN:  1528-1140     ISO Abbreviation:  Ann. Surg.     Publication Date:  2009 Jun 
Date Detail:
Created Date:  2009-06-02     Completed Date:  2009-06-25     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0372354     Medline TA:  Ann Surg     Country:  United States    
Other Details:
Languages:  eng     Pagination:  921-6     Citation Subset:  AIM; IM    
Departments of Vascular Surgery, Erasmus Medical Centre, Rotterdam, the Netherlands.
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MeSH Terms
Adrenergic beta-Antagonists / administration & dosage,  therapeutic use*
Bisoprolol / administration & dosage,  therapeutic use*
Cohort Studies
Drug Therapy, Combination
Fatty Acids, Monounsaturated / administration & dosage,  therapeutic use*
Heart Arrest / mortality,  prevention & control*
Hydroxymethylglutaryl-CoA Reductase Inhibitors / administration & dosage,  therapeutic use*
Indoles / administration & dosage,  therapeutic use*
Middle Aged
Myocardial Infarction / epidemiology,  prevention & control*
Postoperative Complications*
Risk Factors
Treatment Outcome
Reg. No./Substance:
0/Adrenergic beta-Antagonists; 0/Fatty Acids, Monounsaturated; 0/Hydroxymethylglutaryl-CoA Reductase Inhibitors; 0/Indoles; 66722-44-9/Bisoprolol; 93957-54-1/fluvastatin

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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