| Title | 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). | | Author(s) | Dunkelgrun M, Boersma E, Schouten O, Koopman-van Gemert AW, van Poorten F, Bax JJ, Thomson IR, Poldermans D, Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography Study Group | | Institution | Departments of Vascular Surgery, Erasmus Medical Centre, Rotterdam, the Netherlands. | | Source | Ann Surg 2009 Jun; 249(6):921-6. | | MeSH | Adrenergic beta-Antagonists
Aged
Bisoprolol
Cohort Studies
Drug Therapy, Combination
Fatty Acids, Monounsaturated
Female
Heart Arrest
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Incidence
Indoles
Male
Middle Aged
Myocardial Infarction
Postoperative Complications
Risk Factors
Treatment Outcome
| | 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. | | Language | eng | | Pub Type(s) | Comparative Study
Journal Article
Meta-Analysis
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
| | PubMed ID | 19474688 |
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