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Effect of Bisoprolol on Perioperative Mortality and MI in High-Risk Patients Undergoing Vascular Surgery - Effect of Bisoprolol on Perioperative Mortality and MI in High-Risk Patients Undergoing Vascular Surgery
Description:
The goal of this study was to assess the safety and efficacy of perioperative bisoprolol among high-risk patients undergoing major vascular surgery.
Hypothesis:
It was hypothesized that the beta-blockade provided by bisoprolol therapy would be associated with a reduction in the incidence of perioperative cardiac mortality and nonfatal myocardial infarction (MI) in patients undergoing major vascular surgery.
Study Design
Study Design:
Patients Screened: 1,351
Patients Enrolled: 112
Mean Follow Up: 30 days
Mean Patient Age: 60-75
Female: 86
Patient Populations:
Patients with the following cardiac risk factors were screened: age >70 years, angina, prior MI by history or pathologic Q waves on electrocardiography, a history of congestive heart failure, current treatment for ventricular arrhythmias, current treatment for diabetes mellitus, or limited exercise capacity. If a patient had any one of these risk factors, he or she underwent dobutamine echocardiography. If the dobutamine echocardiography was positive, the patients were considered high-risk and were included.
Exclusions:
Individuals were excluded if they had extensive resting wall motion abnormalities on echocardiography (wall-motion index >1.70), asthma, or significant evidence of three-vessel or left main coronary artery disease. Additionally, patients who were already taking beta-blockers were excluded.
Primary Endpoints:
The combined primary endpoint was death from cardiac causes or nonfatal MI within the follow-up period.
Drug/Procedures Used:
Eligible patients were randomized to receive either bisoprolol or standard care. Therapy was to be initiated at least one week prior to surgery and continued for 30 days after surgery.
Bisoprolol was started at a dose of 5 mg orally once per day. One week after the initial dose, patients were evaluated and bisoprolol was titrated to a maximum of 10 mg per day if their resting heart rate was >60 beats per minute (bpm).
In the postoperative period, patients were maintained on their preoperative dose of bisoprolol. The bisoprolol was withheld if the systolic blood pressure was <100 mm Hg or the heart rate was <50 bpm.
Concomitant Medications:
In the immediate postoperative period, intravenous metoprolol was administered as necessary to maintain the heart rate below 80 bpm.
Principal Findings:
In the perioperative period, there was a significant reduction in cardiac mortality among patients in the bisoprolol group (3.4% vs. 17%, p=0.02). The incidence of nonfatal MI was also significantly reduced (0% vs. 17%, p<0.001). The combined endpoint of cardiac mortality or nonfatal MI was significantly reduced in those taking bisoprolol (3.4% vs. 34%, p<0.001).
Interpretation:
Among high-risk patients undergoing major vascular surgical procedures, perioperative bisoprolol was associated with a significant reduction in the primary endpoints of death from cardiac causes and nonfatal MI. These findings suggest that perioperative beta-blockade with bisoprolol therapy may be beneficial when initiated prior to major vascular surgery in high-risk patients.
References:
Poldermans D, Boersma E, Bax JJ, et al. The effect of bisoprolol on perioperative mortality and myocardial infarction in high-risk patients undergoing vascular surgery. Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography Study Group. N Engl J Med 1999;341:1789-94.
Keywords: Myocardial Infarction, Blood Pressure, Perioperative Period, Electrocardiography, Heart Rate, Vascular Surgical Procedures, Peripheral Vascular Diseases, Dobutamine, Heart Failure, Bisoprolol, Diabetes Mellitus, Echocardiography
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