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Bisoprolol Reduces Perioperative Events in Vascular Patients: Data From the Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echo Study Group - DECREASE
Description:
DECREASE was a multicenter, randomized trial to evaluate the effect of perioperative beta-blockade in patients undergoing major vascular surgery with clinical cardiac risk factors and ischemia on dobutamine echocardiography.
Hypothesis:
Compared to standard care, treatment with perioperative bisoprolol would be associated with a decreased incidence of cardiac death and nonfatal myocardial infarction (MI) in high-risk patients undergoing major vascular surgery.
Study Design
Study Design:
Patients Screened: 173
Patients Enrolled: 112
Mean Follow Up: 30 days
Mean Patient Age: 60-75
Female: 18
Patient Populations:
Patients undergoing elective abdominal aortic or infra-inguinal arterial reconstruction with one or more of the following cardiac risk factors: age over 70 years, angina, prior MI, compensated congestive heart failure or a history of congestive heart failure, current treatment for ventricular arrhythmias, current treatment for diabetes mellitus, or limited exercise capacity, defined as the inability to perform most normal daily activities.
Any patient with a risk factor underwent dobutamine echocardiography. Patients who had a positive result on dobutamine echocardiography were considered.
Exclusions:
Extensive wall-motion abnormalities (wall-motion index more than 1.70 at rest), asthma, or strong evidence during stress testing of left main or severe three vessel coronary artery disease. Patients were also excluded if they were already taking a beta-blocker. These patients either continued their usual medication or were switched to bisoprolol. They were treated similarly to patients assigned to the bisoprolol group, but their data were analyzed separately.
Primary Endpoints:
Composite of death from cardiac causes and nonfatal MI
Secondary Endpoints:
Death from other causes and heart rate
Drug/Procedures Used:
Bisoprolol plus standard care versus standard care
Standard care plus bisoprolol arm: Bisoprolol started at least one week before surgery and continued for 30 days postoperatively. The initial dose of bisoprolol was 5 mg orally daily (qd), and starting one week after initiating bisoprolol, the dose was increased to a maximum of 10 mg qd if the heart rate remained above 60 beats per minute (bpm).
The same dose of bisoprolol was continued postoperatively, except in patients who were unable to take medication orally or by nasogastric tube postoperatively. In these patients, IV metoprolol was administered at a dose sufficient to keep the heart rate below 80 bpm. The heart rate and blood pressure were measured immediately before each scheduled dose of bisoprolol. Bisoprolol was withheld if the heart rate was under 50 bpm or the systolic blood pressure was <100 mm Hg.
Concomitant Medications:
Standard perioperative care (beta-blockers were allowed in the standard care group in the circumstance of symptoms or signs of perioperative ischemia accompanied by tachycardia)
Principal Findings:
Of the 1,351 patients screened, 846 had one or more cardiac risk factors, and of these, 173 (20%) had ischemia on dobutamine echocardiography. A total of 112 patients were randomized (61 patients were excluded due to either extensive wall-motion abnormalities or prior beta-blocker use). The two study groups were well-balanced with respect to baseline characteristics, and patients in the bisoprolol group (drug started an average of 37 days prior to surgery) had lower heart rates prior to surgery (66 bpm vs. 79 bpm, p<0.001).
In the bisoprolol arm compared to the standard care arm, there was a lower incidence of cardiac death (3.4% vs. 17%, p=0.02), nonfatal MI (0% vs. 17%, p<0.001), and a 10-fold lower incidence of the combined primary endpoint (3.4% vs. 34%, p<0.001, relative risk of 0.09). Based on these findings, the study was terminated early after an interim analysis. In the eight patients not randomized due to extensive wall motion abnormalities, four underwent coronary artery bypass graft (of these, two died and two had an uneventful vascular surgery), and the other four underwent vascular surgery without revascularization, but with perioperative beta-blockers (there were no deaths, and one perioperative MI).
Interpretation:
Among high-risk patients, perioperative treatment with bisoprolol was associated with a markedly decreased incidence of cardiac death and nonfatal MI. Whether these benefits are sustained in patients undergoing preoperative revascularization has not been studied in a randomized fashion.
Caution should be exercised in generalizing these results to other beta-blockers. Nevertheless, the low event rate in the bisoprolol arm, despite the presence of clinical risk factors and inducible ischemia, lends support to the recommendations that beta-blocker therapy should be the standard of care among high-risk patients undergoing vascular surgery.
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, Standard of Care, Blood Pressure, Risk Factors, Heart Rate, Peripheral Vascular Diseases, Dobutamine, Heart Failure, Bisoprolol, Metoprolol, Coronary Artery Bypass, Diabetes Mellitus, Echocardiography
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