Abstract 4536: Bisoprolol and Fluvastatin for the Reduction of Perioperative Cardiac Mortality and Myocardial Infarction in Intermediate-Risk Patients Undergoing Non-Cardiovascular Surgery; a Randomized Controlled Trial
Beta-blockers and statins reduce perioperative cardiac events in high-risk patients undergoing vascular surgery. This study evaluated the effectiveness and safety of these agents on cardiac outcome in intermediate-risk patients. Prior to surgery, 1066 intermediate-risk patients were randomly assigned to bisoprolol, fluvastatin, combination treatment or control therapy. Intermediate-risk patients were defined by an estimated risk of perioperative cardiac death and myocardial infarction (MI) of 1 – 6 percent, using clinical data and type of surgery. Medication started at median 34 days prior to surgery (interquartile range 21–53). Starting dose of bisoprolol was 2.5 mg daily, and titrated to a perioperative heart rate of 50 –70 beats per minute. Fluvastatin was prescribed in a fixed daily dose of 80 mg. The primary endpoint was the composite of cardiac death and MI 30 days after surgery. Patients randomized to bisoprolol (N=533) had a lower incidence of the primary endpoint than those randomized to bisoprolol-control therapy (2.1% vs. 6.0% events; hazard ratio [HR] 0.34; 95% confidence interval [CI]: 0.17– 0.67; p=0.002). The beneficial effects of bisoprolol were not modified by fluvastatin. Patients randomized to fluvastatin experienced a lower incidence of the primary efficacy endpoint than those randomized to fluvastatin-control therapy (3.2% vs. 4.9% events; HR 0.65; 95% CI 0.35–1.10), but statistical significance was not reached (p=0.17). In intermediate-risk surgical patients, bisoprolol was associated with a significant reduction of 30-day cardiac complications, while fluvastatin showed a trend for improved outcome.