The Effect of Bisoprolol on Perioperative Mortality and Myocardial Infarction in High-Risk Patients Undergoing Vascular Surgery
Don Poldermans, Ph.D., Eric Boersma, Ph.D., Jeroen J. Bax, Ph.D., Ian R. Thomson, Ph.D., Louis L.M. van de Ven, Ph.D., Jan D. Blankensteijn, Ph.D., Hubert F. Baars, M.D., Tik-Ien Yo, Ph.D., Giuseppe Trocino, M.D., Carlo Vigna, M.D., Jos R.T.C. Roelandt, Ph.D., Hero van Urk, Ph.D., Paolo M. Fioretti, Ph.D., Bernard Paelinck, M.D., for The Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography Study Group
Background Cardiovascular complications are the most importantcauses of perioperative morbidity and mortality among patientsundergoing major vascular surgery.
Methods We performed a randomized, multicenter trial to assessthe effect of perioperative blockade of beta-adrenergic receptorson the incidence of death from cardiac causes and nonfatal myocardialinfarction within 30 days after major vascular surgery in patientsat high risk for these events. High-risk patients were identifiedby the presence of both clinical risk factors and positive resultson dobutamine echocardiography. Eligible patients were randomlyassigned to receive standard perioperative care or standardcare plus perioperative beta-blockade with bisoprolol.
Results A total of 1351 patients were screened, and 846 werefound to have one or more cardiac risk factors. Of these 846patients, 173 had positive results on dobutamine echocardiography.Fifty-nine patients were randomly assigned to receive bisoprolol,and 53 to receive standard care. Fifty-three patients were excludedfrom randomization because they were already taking a beta-blocker,and eight were excluded because they had extensive wall-motionabnormalities either at rest or during stress testing. Two patientsin the bisoprolol group died of cardiac causes (3.4 percent),as compared with nine patients in the standard-care group (17percent, P=0.02). Nonfatal myocardial infarction occurred innine patients given standard care only (17 percent) and in noneof those given standard care plus bisoprolol (P<0.001). Thus,the primary study end point of death from cardiac causes ornonfatal myocardial infarction occurred in 2 patients in thebisoprolol group (3.4 percent) and 18 patients in the standard-caregroup (34 percent, P<0.001).
Conclusions Bisoprolol reduces the perioperative incidence ofdeath from cardiac causes and nonfatal myocardial infarctionin high-risk patients who are undergoing major vascular surgery.
Patients undergoing major vascular surgery are at risk for seriousperioperative cardiac complications, such as nonfatal myocardialinfarction and death.1 A combination of clinical assessmentand noninvasive cardiac testing can be used to identify patientsat high risk.2 Various interventions have been proposed to reducethe risk of cardiac complications in such patients after noncardiacsurgery, but none have been found to be efficacious.
Drugs that block beta-adrenergic receptors prevent cardiac complicationsin patients with acute myocardial infarction, silent ischemia,and heart failure.3,4,5,6 Perioperative blockade of beta-adrenergicreceptors has been proposed to reduce the risk of perioperativecardiac complications.7,8,9 However, previous trials lackedthe statistical power to evaluate the cardioprotective effectof beta-blockade on the incidence of serious cardiac events,such as death or nonfatal myocardial infarction.
We hypothesized that perioperative beta-blockade with bisoprololwould reduce the perioperative incidence of death from cardiaccauses and nonfatal myocardial infarction in high-risk patientsundergoing major vascular surgery. We therefore performed amulticenter study of a subgroup of high-risk patients who hadclinical predictors of cardiac risk together with positive resultson dobutamine echocardiography.
Methods
Study Protocol
Between 1996 and 1999, we prospectively screened all patientsundergoing elective abdominal aortic or infrainguinal arterialreconstruction at seven participating centers. The ethics committeeat each center approved the study protocol. The patients werescreened for the following cardiac risk factors: age over 70years; angina; prior myocardial infarction on the basis of historyor a finding of pathologic Q waves on electrocardiography; compensatedcongestive heart failure or a history of congestive heart failure;current treatment for ventricular arrhythmias; current treatmentfor diabetes mellitus; or limited exercise capacity, definedas the inability to perform most normal daily activities. Anypatient with a risk factor underwent dobutamine echocardiography.Patients who had a positive result on dobutamine echocardiographywere considered at high risk.
Patients were excluded if they had extensive wall-motion abnormalities(wall-motion index more than 1.70 at rest), asthma, or strongevidence during stress testing of left main or severe three-vesselcoronary artery disease. Patients were also excluded if theywere already taking a beta-adrenergic–receptor antagonist.These patients either continued their usual medication or wereswitched to bisoprolol. They were treated similarly to patientsassigned to the bisoprolol group, but their data were analyzedseparately.
After giving written informed consent, eligible patients wererandomly assigned to receive either standard perioperative careor standard care plus bisoprolol. A computer algorithm was usedat each center to assign patients randomly, in a one-to-oneratio, to one of the two study groups. Treatment with bisoprolol,a selective ß1-adrenergic–receptor antagonist,was started at least 1 week before surgery and continued for30 days postoperatively.
The initial dose of bisoprolol was 5 mg orally once a day. Approximatelyone week after starting bisoprolol, the patients were reassessed,and the dose was increased to a maximum of 10 mg once dailyif the heart rate remained above 60 beats per minute. The samedose of bisoprolol was continued postoperatively except in patientswho were unable to take medication orally or by nasogastrictube postoperatively. In these patients, the heart rate wasmonitored continuously in the intensive care unit or hourlyon the ward, and intravenous metoprolol was administered ata dose sufficient to keep the heart rate below 80 beats perminute. The heart rate and blood pressure were measured immediatelybefore each scheduled dose of bisoprolol. Bisoprolol was withheldif the heart rate was under 50 beats per minute or the systolicblood pressure was under 100 mm Hg.
Dobutamine Echocardiography
Dobutamine echocardiography was performed as described previously.10The left ventricle was divided into 16 segments, and wall motionwas scored on a 5-point scale (with a score of 1 indicatingnormal, 2 mild hypokinesis, 3 severe hypokinesis, 4 akinesis,and 5 dyskinesis). The results were considered positive if wallmotion in any segment decreased by one or more grades duringtesting. The extent and location of ischemia were evaluatedin every patient, and a wall-motion index was calculated atrest.
Perioperative Management
Anesthetic management, monitoring, surgical technique, and otheraspects of perioperative management were at the discretion ofthe attending physicians. The attending physicians were awareof the patients' echocardiographic results and treatment groups.If symptoms or signs of perioperative myocardial ischemia accompaniedby tachycardia developed in a patient in the standard-care group,the attending physician was permitted to administer beta-adrenergic–receptorantagonists.
Follow-Up
The patients were monitored for cardiac events for 30 days aftersurgery. Twelve-lead echocardiography was performed and theserum creatine kinase level (with the MB fraction) was determinedone, three, and seven days after surgery. Additional measurementswere performed at the discretion of the attending physician.Outpatient follow-up was performed at 30 days if a patient hadbeen discharged from the hospital. All data were collected bythe participating centers and evaluated in a masked fashionby members of the adverse-events committee. The primary endpoints were death from cardiac causes or nonfatal myocardialinfarction during the perioperative period. The cause of deathwas determined by reviewing the clinical presentation, includingserum cardiac isoenzyme levels, 12-lead electrocardiograms,and, when available, autopsy results. Nonfatal myocardial infarctionwas defined by a serum creatine kinase level of more than 110U per liter, with an MB isoenzyme fraction of more than 10 percent,and a finding of new Q waves lasting more than 0.03 second onthe electrocardiogram.
Statistical Analysis
The calculation of sample size was based on a previous studyin which we noted a 28 percent incidence of serious perioperativecardiac events in patients who had clinical risk factors aswell as positive results on dobutamine echocardiography.11 Wecalculated that the inclusion of 266 patients would allow usto detect a reduction in the incidence of the primary end pointfrom 30 percent to 15 percent with an alpha level of 0.05 anda statistical power of 0.80. As part of the study design, aninterim analysis by an independent safety committee was plannedafter enrollment of the first 100 patients. In accordance withthe O'Brien and Fleming criteria,12 the protocol specified thatthe trial would be stopped if there was a significant differencein the rate of the primary end point between the bisoprololgroup and the control group (P=0.001).
Continuous data are presented as median values and corresponding25th and 75th percentiles, whereas dichotomous data are presentedas percentages. Differences between the groups of patients inclinical and surgical characteristics and in the results ofdobutamine echocardiography were evaluated by Wilcoxon's nonparametrictest or Fisher's exact test, whichever was appropriate. Differencesbetween the groups in the rates of occurrence of the primaryend point were evaluated by Fisher's exact test. Event rateswere further examined by the Kaplan–Meier method and acorresponding log-rank test. Cox proportional-hazards regressionanalysis was performed to estimate the relative risk of theend point. Analyses were performed according to the intentionto treat.
Results
Characteristics of the Patients
A total of 1351 patients were screened, and 846 were found tohave one or more cardiac risk factors. Stress-induced ischemiaoccurred in 173 of the 846 patients (20 percent) during dobutamineechocardiography. Of these patients, 112 underwent randomization:59 were assigned to receive bisoprolol plus standard care and53 to receive standard care alone. All but one patient underwentthe planned vascular surgical procedure after randomization.Sixty-one patients did not undergo randomization: 53 were alreadytaking a beta-blocker at enrollment and underwent the plannedvascular surgical procedure while continuing to take this medication,and 8 had extensive wall-motion abnormalities.
The clinical characteristics of the randomized patients arepresented in Table 1. The results of dobutamine echocardiography,details of the surgical procedure, and important aspects ofperioperative management are presented in Table 2 and Table 3.There were no significant differences between the groupswith respect to any of these variables. Patients in the bisoprololgroup had significantly lower heart rates before surgery andduring the perioperative period than did those given standardcare (Table 4).
Table 4. Mean Heart Rates of Randomized Patients at Base Line and One, Three, and Seven Days Postoperatively.
Beta-Blockade
In the bisoprolol group, bisoprolol was started an average of37 days (range, 7 to 89) before surgery. The daily dose was10 mg in 15 patients and 5 mg in 44. All these patients receivedbisoprolol orally on the morning of surgery. The day after surgery,bisoprolol was administered either orally or by nasogastrictube in 31 patients and intravenously in 28 patients. By thefourth day after surgery, all patients had resumed oral therapy.No patient in this group had a preoperative exacerbation ofunderlying peripheral vascular disease.
Cardiac Events in Randomized Patients
Nine patients in the standard-care group (17 percent) died ofcardiac causes during the perioperative period, as comparedwith two patients (3.4 percent) in the bisoprolol group (P=0.02).There were no deaths from other causes. Nine patients in thestandard-care group (17 percent) had a nonfatal myocardial infarction,as compared with none in the bisoprolol group (P<0.001).Eight of the infarctions occurred postoperatively, and one occurredpreoperatively. The one preoperative infarction was considereda primary end point, even though the surgery was canceled. Theoverall rate of the combined end point of death from cardiaccauses or nonfatal myocardial infarction was 34 percent (95percent confidence interval, 21 to 48 percent) in the standard-caregroup, as compared with 3.4 percent (95 percent confidence interval,0 to 8.0 percent; P<0.001) in the bisoprolol group. The estimatedrelative risk of death from cardiac causes or nonfatal myocardialinfarction during the perioperative period among patients receivingbisoprolol therapy, as compared with those receiving standardcare, was 0.09 (95 percent confidence interval, 0.02 to 0.37).Four patients in the standard-care group received beta-blockersperioperatively because of severe intraoperative myocardialischemia or postoperatively because of unstable angina.
The significant difference between groups in the incidence ofserious cardiac events prompted the safety committee to interruptthe study after the planned interim analysis. While the safetycommittee was evaluating the results, six additional patientsunderwent randomization. The number of patients who reachedthe end point is presented in Figure 1. The majority of eventsoccurred during the first seven days after surgery.
Figure 1. Kaplan–Meier Estimates of the Cumulative Percentages of Patients Who Died of Cardiac Causes or Had a Nonfatal Myocardial Infarction during the Perioperative Period.
I bars indicate standard errors. The difference between groups was significant (P<0.001 by the log-rank test).
Cardiac Events in Nonrandomized Patients
Among the 53 patients with positive results on dobutamine echocardiographywho were already taking a beta-blocker, 4 (7.5 percent) diedof cardiac causes during the perioperative period and none hada myocardial infarction. The eight patients who did not undergorandomization because of extensive resting or stress-inducedwall-motion abnormalities (or both) had a median wall-motionindex of 1.84 and had new wall-motion abnormalities in sevensegments. Four of these patients underwent coronary-artery bypassgrafting, and two of them died. The two surviving patients subsequentlyunderwent uneventful vascular surgery. The other four patientsunderwent vascular surgery without prior myocardial revascularizationbut with perioperative administration of beta-blockers. Noneof these four patients died, but one had a perioperative myocardialinfarction.
Discussion
In this randomized, multicenter study, we found that perioperativeadministration of bisoprolol reduced the perioperative incidenceof both death from cardiac causes and nonfatal myocardial infarctionin high-risk patients undergoing major vascular surgery. Thecombined incidence of these cardiac events was 34 percent inthe standard-care group, as compared with 3.4 percent in thebisoprolol group; this difference caused the safety committeeto interrupt the study after the first planned interim analysis.The observed treatment effect is not attributable to differencesbetween the two groups with respect to clinical characteristics,results on dobutamine echocardiography, surgical procedures,anesthetic or analgesic technique, or the duration of hospitalizationin the intensive care unit.
At first glance, the 34 percent rate of serious perioperativeevents in the standard-care group seems high. However, thisrate is consistent with the results of a previous study at oneof our institutions. In a group of 300 consecutive patients,the incidence of serious cardiac events was 28 percent in patientswith one or more risk factors and positive results on dobutamineechocardiography.11 Other investigators have noted high ratesof perioperative cardiac events in patients in whom ischemiacan be induced on perioperative testing.13,14,15
The cause of the perioperative cardiac events remains undefined.Such events occur almost exclusively among patients with positiveresults on dobutamine echocardiography,11 suggesting that hemodynamicallysignificant coronary-artery stenosis has an essential role inthe pathogenesis of perioperative coronary ischemic syndromes.Coronary stenosis may increase a patient's vulnerability toischemia or infarction caused by perioperative hemodynamic instability,anemia, hypoxemia, hypercoagulability, or rupture of coronaryatherosclerotic plaques.
The mechanism by which beta-blockade reduces perioperative cardiacevents is also unclear. Several mechanisms have been proposed.Myocardial oxygen balance may be improved by decreases in theheart rate and myocardial contractility, thus preventing myocardialischemia, reducing the size of the infarct, or both. Beta-blockademay reduce myocardial oxygen consumption by suppressing lipolysisand thus causing the myocardium to metabolize more glucose inrelation to free fatty acids. Beta-blocking drugs may increasethe stability of coronary atherosclerotic plaques or increasethe threshold for ventricular fibrillation in the presence ofischemia.6 Antagonists of beta-adrenergic receptors have alsobeen shown to improve the outcome among patients with acutemyocardial infarction, silent ischemia, and heart failure.3,4,5
The only previous randomized, controlled study evaluating thecardioprotective effect of beta-adrenergic antagonists in patientsundergoing major surgery was performed by Mangano and colleagues.7,8In this study, 200 patients who had or were at risk for coronaryartery disease were randomly assigned to receive atenolol orplacebo during the perioperative period. The patients were monitoredperioperatively for cardiac events and then followed for twoyears after surgery. During the first 48 hours after surgery,the incidence of myocardial ischemia, as detected by continuousthree-lead Holter monitoring, was reduced by 50 percent in patientsgiven atenolol. During the two-year follow-up period, the mortalityrate was 10 percent in patients given atenolol and 21 percentin the controls. However, atenolol did not significantly reducethe incidence of death from cardiac causes during hospitalizationor that of perioperative myocardial infarction.
The failure of atenolol to alter the perioperative outcome significantlyreflects the low incidence of serious perioperative cardiacevents in the study population (3 percent). The study includedboth patients with known coronary artery disease and those withonly coronary risk factors, and the patients underwent varioussurgical procedures. In contrast, we studied a population ofpatients who were undergoing vascular surgery who were identifiedby clinical screening and dobutamine echocardiography as beingat high risk, with an anticipated rate of cardiac events of28 percent. Our results demonstrate the importance of testingrisk-reduction strategies in a subgroup of high-risk patients.
Preoperative evaluation offers a unique opportunity to screenpatients for underlying coronary artery disease and cardiacrisk factors that affect the perioperative outcome. A task forceof the American College of Cardiology and the American HeartAssociation has published guidelines for the preoperative cardiovascularevaluation of patients scheduled for noncardiac surgery.2 Accordingto these guidelines, patients undergoing vascular surgery whohave intermediate risk factors (Canadian Cardiovascular Societyclass I or II angina, myocardial infarction, congestive heartfailure, or diabetes mellitus) or limited exercise capacityshould undergo a noninvasive cardiac evaluation before surgery.We prefer dobutamine echocardiography for this purpose, becauseof its extremely high negative predictive value and becauseit can be used in patients who cannot exercise. Patients withno clinical risk factors and without stress-induced ischemiahave a rate of serious perioperative cardiac events that isclose to zero.12 They can undergo surgery without extra evaluationor extensive monitoring. Patients with a positive test resultare at high risk and are candidates for perioperative risk-reductionmeasures.
On the basis of our results, we recommend that high-risk surgicalpatients receive beta-blockers perioperatively, beginning oneto two weeks before surgery. The goal should be to reduce theheart rate to less than 70 beats per minute preoperatively andto less than 80 beats per minute in the immediate postoperativeperiod. Therapy should be continued for at least two weeks postoperatively.An alternative to this approach would be to omit preoperativenoninvasive cardiac testing and prescribe a beta-blocker perioperativelyfor all patients with clinical risk factors who are undergoinghigh-risk surgery. Although our results applied to patientswho were undergoing major vascular surgery, we recommend thathigh-risk patients undergoing other types of noncardiac surgeryreceive a beta-blocker perioperatively.
Our study has several limitations. Most important, it was notconducted in a blinded fashion. The attending physicians knewwhich treatment had been prescribed, and bias on their partmay have affected the management and outcome. However, we foundno significant differences in major aspects of perioperativetreatment (e.g., anesthetic or analgesic technique or durationof hospitalization in the intensive care unit) between the twogroups. The rate of events in the standard-care group was nothigher than that predicted on the basis of our previous work.It is unlikely that factors other than the use of beta-blockerscan account for the reduced rate of events in the bisoprololgroup. For such factors to have affected the outcome, physiciansat eight different institutions would have had to use —consistently and exclusively — an unproved, but extremelyeffective, risk-reduction strategy in the bisoprolol group.
The lack of blinding may also have affected the reporting ofevents. Systematic screening for myocardial infarction withthe use of cardiac isoenzyme levels and electrocardiographywas performed only during the first week after surgery. Subsequenttesting was discretionary and may have been influenced by biason the part of the investigators. Such bias may have affectedthe diagnosis and reporting of myocardial infarctions afterthe first week. However, most infarctions occurred in the firstseven days after surgery and would have been detected by routinescreening.
Our decision to exclude eight patients with extensive restingor stress-induced wall-motion abnormalities was arbitrary andmay have affected the results. Our exclusion criteria were establishedbefore the study began and reflected our belief that it wouldbe inappropriate to constrain the perioperative care of thesepatients in any way. There is little doubt that the randomizedpatients still constitute an appropriate high-risk group inwhich to test the value of perioperative beta-blockade.
There were doubtless minor variations between centers in theinterpretations of the results of dobutamine echocardiography,but the outcome in the standard-care group shows that the presenceof one or more risk factors plus a positive test result doesdefine a high-risk population. Furthermore, since randomizationwas performed at each participating center, differences in theresults of dobutamine echocardiography between centers wouldnot have biased the overall results.
In conclusion, we found that bisoprolol reduces the perioperativeincidence of death from cardiac causes and of nonfatal myocardialinfarction in high-risk patients undergoing abdominal aorticor infrainguinal arterial reconstructive surgery.
* The members of the study group are listed in the Appendix.
Source Information
From Erasmus Medical Center, Rotterdam, the Netherlands (D.P., E.B., J.J.B., L.L.M.V., J.R.T.C.R., H.U.); the University of Manitoba, Winnipeg, Canada (I.R.T.); University Hospital, Utrecht, the Netherlands (J.D.B.); Twee Steden Ziekenhuis, Tilburg, the Netherlands (H.F.B.); Sint Clara Ziekenhuis, Rotterdam, the Netherlands (T.-I.Y.); San Gerardo Hospital, Monza, Italy (G.T.); and Istituto di Ricovero e Cura a Carattere Scientifico Hospital, San Giovanni Rotondo, Italy (C.V.). Other authors were Paolo M. Fioretti, Ph.D., Istituto di Cardiologia, Azienda Ospedaliera, Santa Maria della Misericordia, Udine, Italy; and Bernard Paelinck, M.D., Ziekenhuis Middelheim, Antwerp, Belgium.
Address reprint requests to Dr. Poldermans at the Department of Vascular Surgery, Erasmus University Medical Center, Dr. Molewaterplein 40, 3015 GD Rotterdam, the Netherlands, or at poldermans{at}hlkd.azr.nl.
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Appendix
The members of the Dutch Echocardiographic Cardiac Risk EvaluationApplying Stress Echocardiography study group and the participatingcenters were as follows: Steering committee — D. Poldermans,I.R. Thomson, H. van Urk, J.J. Bax, P.M. Fioretti, A.J. Manin 't Veld, L.L.M. van de Ven, and J.R.T.C. Roelandt; Statisticalanalysis — E. Boersma; Data-base management — V.C.Poldermans and A. Schyns; Adverse-events committee — P.van de Meer and P. Klootwijk; Safety committee — M.L.Simoons and G.A. van Es; Participating centers — the Netherlands:Erasmus Medical Center, Rotterdam (D. Poldermans, M. van Nierop,H. van Urk); Sint Clara Ziekenhuis, Rotterdam (M.G. Scheffer,T.-I. Yo); Twee Steden Ziekenhuis, Tilburg (H.F. Baars, S. Berends,S.E. Kranendonk); Academisch Ziekenhuis, Utrecht (J.D. Blankensteijn,H.W.J. Meijburg, R. Rienks); and Medisch Centrum, Alkmaar (J.H.Cornel, H.A. van Dijk); Belgium: Ziekenhuis Middelheim Antwerp(B. Paelinck); Italy: San Gerardo Hospital, Monza (G. Emanuelli,G. Trocino, A. Virtuani, M. Zerbato); and Istituto di Ricoveroe Cura a Carattere Scientifico Hospital, San Giovanni Rotondo(C. Vigna, G. Colacchio).
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