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).

Abstract

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.

• Authors: 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
• Journal: Annals of surgery (Ann Surg) Vol. 249 Issue 6 Pg. 921-6 (Jun 2009) ISSN: 1528-1140 [Electronic] United States
• PMID: 19474688 (Publication Type: Comparative Study, Journal Article, Meta-Analysis, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Adrenergic beta-Antagonists
• Fatty Acids, Monounsaturated
• Hydroxymethylglutaryl-CoA Reductase Inhibitors
• Indoles
• Fluvastatin
• Bisoprolol

Topics

• Adrenergic beta-Antagonists (administration & dosage, therapeutic use)
• Aged
• Bisoprolol (administration & dosage, therapeutic use)
• Cohort Studies
• Drug Therapy, Combination
• Fatty Acids, Monounsaturated (administration & dosage, therapeutic use)
• Female
• Fluvastatin
• Heart Arrest (mortality, prevention & control)
• Humans
• Hydroxymethylglutaryl-CoA Reductase Inhibitors (administration & dosage, therapeutic use)
• Incidence
• Indoles (administration & dosage, therapeutic use)
• Male
• Middle Aged
• Myocardial Infarction (epidemiology, prevention & control)
• Postoperative Complications
• Risk Factors
• Treatment Outcome