Background Long-term administration of beta-adrenergic blockersto patients after myocardial infarction improves survival. However,physicians are reluctant to administer beta-blockers to manypatients, such as older patients and those with chronic pulmonarydisease, left ventricular dysfunction, or non–Q-wave myocardialinfarction.
Methods The medical records of 201,752 patients with myocardialinfarction were abstracted by the Cooperative CardiovascularProject, which was sponsored by the Health Care Financing Administration.Using a Cox proportional-hazards model that accounted for multiplefactors that might influence survival, we compared mortalityamong patients treated with beta-blockers with mortality amonguntreated patients during the two years after myocardial infarction.
Results A total of 34 percent of the patients received beta-blockers.The percentage was lower among the very elderly, blacks, andpatients with the lowest ejection fractions, heart failure,chronic obstructive pulmonary disease, elevated serum creatinineconcentrations, or type 1 diabetes mellitus. Nevertheless, mortalitywas lower in every subgroup of patients treated with beta-blockadethan in untreated patients. In patients with myocardial infarctionand no other complications, treatment with beta-blockers wasassociated with a 40 percent reduction in mortality. Mortalitywas also reduced by 40 percent in patients with non–Q-waveinfarction and those with chronic obstructive pulmonary disease.Blacks, patients 80 years old or older, and those with a leftventricular ejection fraction below 20 percent, serum creatinineconcentration greater than 1.4 mg per deciliter (124 µmolper liter), or diabetes mellitus had a lower percentage reductionin mortality. Given, however, the higher mortality rates inthese subgroups, the absolute reduction in mortality was similarto or greater than that among patients with no specific riskfactors.
Conclusions After myocardial infarction, patients with conditionsthat are often considered contraindications to beta-blockade(such as heart failure, pulmonary disease, and older age) andthose with nontransmural infarction benefit from beta-blockertherapy.
Several large trials have demonstrated that the long-term administrationof beta-adrenergic blockers to patients after myocardial infarctionimproves survival.1,2,3 Although the percentage of such patientsreceiving beta-blockade has recently increased, physicians stillreportedly prescribe beta-blockers for less than one third,4and cardiologists for less than half,5 of patients with myocardialinfarction. Older age, impaired left ventricular function, transientheart failure, and the use of diuretic drugs predict lack ofuse of these drugs.6 This suggests that physicians are concernedthat beta-blockers may be contraindicated in a substantial proportionof patients.
The Cooperative Cardiovascular Project, a program to evaluatethe care of Medicare patients with a diagnosis of myocardialinfarction, provides the opportunity to evaluate the relationbetween treatment and outcome in unselected patients, most ofwhom are over 65 years of age. With more than 200,000 chartsabstracted, this data base gives investigators the power toevaluate the effect of interventions in situations rarely studiedbefore. Moreover, this data base provides information on unselectedpatients with conditions that often keep them out of randomized,controlled trials.
We sought to use the Cooperative Cardiovascular Project datato determine which patients benefit from the use of beta-blockers.We compared the mortality rates of patients in high- and low-risksubgroups who were treated with beta-blockers with the ratesamong those not given those drugs. Correcting to the extentpossible for differences between the groups, we evaluated theeffects of beta-blockers in patients with presumed contraindicationsto their use, such as older age, low ejection fraction, chronicobstructive pulmonary disease, diabetes mellitus, low bloodpressure, and low heart rate. In addition, the data base providedthe opportunity to look at beta-blockade in the setting of contemporarymedical practice.
Methods
The Cooperative Cardiovascular Project data base includes allacute care hospital claims for patients with a principal diagnosisof acute myocardial infarction that were submitted to the HealthCare Financing Administration for Medicare payment. A diagnosisof acute myocardial infarction was defined according to thecoding system of the International Classification of Diseases,9th Revision, Clinical Modification (ICD-9-CM), as code 410,with those with a fifth digit of 2 (for episode of care), thosereported by nonacute care hospitals, and those with missingmedical-record numbers excluded. The national sample consistedof all discharges involving cases of acute myocardial infarctionduring an eight-month period, with data from the various statescollected so that most discharges fell between February 1994and July 1995.
The total number of discharges in the national sample was 201,752.The abstraction was performed by trained medical abstractorsusing uniform criteria to define each data item. They had accessto all original hospital records. Extensive quality-controlmeasures were applied to validate the reliability and accuracyof the abstracts. Finally, extensive checks were run againstthe computerized abstracts to ensure internal consistency andto enforce common data standards.7
The data were nearly complete. Serum creatinine concentrationswere missing for 9575 patients, and most other data were missingfor even fewer patients. The ejection fraction was obtainedor documented in 134,238 patients. Patients for whom the ejectionfraction was missing were analyzed as a separate subgroup. Toavoid eliminating the few patients who had other missing datafrom the analyses, we combined patients with missing data intothe largest group for all variables other than the one beinganalyzed.
Whenever possible, the data reflect the values obtained on admissionto the hospital. The Health Care Financing Administration'ssurvival data were based on Social Security records and werecomplete, with accuracy of 98 to 99 percent, at 60 days.
In this study, the Cooperative Cardiovascular Project data wereused to address the question of who benefits from beta-blockertherapy. Initially, the patients prescribed and not prescribedbeta-blocker therapy were compared with regard to a number ofdemographic and clinical variables. Patients for whom any beta-blockerat any dose had been prescribed at the time of discharge wereclassified as having received a beta-blocker. The means andstandard deviations of continuous variables were compared. Bothcontinuous (in categories) and discrete variables were comparedwith contingency-table analyses.
Comparison of mortality rates between patients receiving andthose not receiving beta-blocker therapy was based on a time-to-eventanalysis. The Cox proportional-hazards model was used for thispurpose, because it permitted estimated survival time to becontrolled for differences in follow-up time and differencesin covariates that might affect survival, including both confoundingvariables and effect modifiers. The proportional-hazards assumptionwas initially checked with Kaplan–Meier analyses and wasfound to be adequately met. Only 8464 of the total of 201,752patients were not followed for 24 months.
Because of the size of the data set, emphasis was placed onthe magnitude rather than the statistical significance of differencesbetween groups. We recognized that very small differences could(and did) achieve statistical significance.
Results
Thirty-four percent of the patients received beta-blockers (Table 1).The percentage was lower among the very elderly, blacks,and those patients considered the sickest according to theirAcute Physiology and Chronic Health Evaluation (APACHE II)8and Killip9 scores. Similarly, patients with the lowest ejectionfractions, heart failure, chronic obstructive pulmonary disease,elevated serum creatinine concentrations, or type 1 diabetesmellitus were less likely to be treated with beta-blockade.Conversely, patients who had been given more aggressive treatment,including thrombolysis and angioplasty, but not bypass surgery,were more likely to be receiving beta-blockers.
Table 1. Characteristics of Patients Who Received or Did Not Receive Beta-Blockers at Hospital Discharge.
As a result of these prescribing practices, patients receivingbeta-blockers tended to have fewer risk factors for mortalitythan those not receiving beta-blockers. They were younger (mean[±SD] age, 73.3±8.8 vs. 74.5±9.0 years)and had lower (i.e., more favorable) APACHE II scores (7.9±3.4vs. 9.0±4.4) and lower Killip scores. Their hospitalstay was shorter (7.2±5.1 vs. 7.8±7.5 days), andtheir physiologic condition, as indicated by the serum creatinineconcentration (1.3±1.0 vs. 1.4±1.1 mg per deciliter[115±88 vs. 124±97 µmol per liter]) andleft ventricular ejection fraction (47±13 percent vs.44±14 percent), was better. They had fewer coexistingdiseases, including chronic obstructive pulmonary disease, diabetes,and congestive heart failure. Finally, they were more likelyto be given thrombolytic and reperfusion therapy. The only exceptionsto the favorable profile among those prescribed beta-blockerswere the slightly higher proportions of patients with hypertensionand of men in this group.
Because of the better risk-factor profile among those treatedwith beta-blockers, it was necessary to hold each risk factorconstant when comparing mortality among those treated and thosenot treated with beta-blockers. Each of the subsequent analysestook direct account of or held constant the following factors:age; race or ethnic group; sex; APACHE II score; length of hospitalstay; Killip score; physiologic condition at admission, as reflectedby the systolic blood pressure, pulse rate, and serum creatinineconcentration; left ventricular ejection fraction; presenceor absence of coexisting diseases, including diabetes, congestiveheart failure, chronic obstructive pulmonary disease, and asthma;type of myocardial infarction (anterior, inferior, or non–Q-wave);history of myocardial infarction, revascularization, or heartfailure; and treatment, including aspirin, angiotensin-converting–enzymeinhibitors, calcium-channel blockers, heparin, thrombolyticagents, coronary angioplasty, and bypass surgery.
Table 2 shows the 24-month adjusted risks and relative risksof death among patients prescribed beta-blockers and those notprescribed the drugs. After demographic and physiologic measuresand coexisting diseases were accounted for, patients treatedwith beta-blockade had substantially lower mortality in everysubgroup. Among patients with myocardial infarction and no othercomplications, treatment with beta-blockers was associated witha 40 percent reduction in mortality during the follow-up period.Mortality was also reduced by 40 percent among patients withnon–Q-wave infarction (Figure 1) and patients with chronicobstructive pulmonary disease (Figure 2). However, the reductionin mortality among those treated with beta-blockers was smalleramong black patients (28 percent). Older patients (Figure 3)and those with a left ventricular ejection fraction below 20percent (Figure 4), a serum creatinine concentration higherthan 1.4 mg per deciliter, or diabetes mellitus also had a smallerpercentage reduction in mortality. However, because of the highermortality rates in these subgroups, the use of beta-blockersactually resulted in an absolute reduction in mortality similarto or greater than that in patients with no specific risk factors.
Figure 1. Adjusted Probability of Survival among Patients with Q-Wave and Non–Q-Wave Myocardial Infarction (MI) Who Received or Did Not Receive Beta-Blockers.
The patients with Q-wave infarction and those with non–Q-wave infarction had similar benefit with beta-blockade.
Figure 2. Adjusted Probability of Survival among Patients with or without a History of Chronic Obstructive Pulmonary Disease (COPD) Who Received or Did Not Receive Beta-Blockers.
Patients with chronic obstructive pulmonary disease had a larger absolute benefit with beta-blockade.
Figure 3. Adjusted Probability of Survival According to Age among Patients Who Received or Did Not Receive Beta-Blockers.
The oldest patients had a smaller relative benefit (32 percent reduction in the risk of death) but a larger absolute benefit than younger patients. The curve for the patients not receiving beta-blockers who were 70 to 79 years old overlaps that for the patients receiving beta-blockers who were 80 years old.
Figure 4. Adjusted Probability of Survival According to Left Ventricular Ejection Fraction among Patients Who Received or Did Not Receive Beta-Blockers.
Patients with ejection fractions under 20 percent had a smaller relative benefit but a larger absolute benefit than patients with normal ejection fractions. The curve for the patients not receiving beta-blockers who had left ejection fractions of 20 through 49 percent overlaps that for the patients receiving beta-blockers who had left ejection fractions below 20 percent.
Discussion
Patients who received beta-blockers had a 40 percent lower mortalityrate than those who did not have beta-blockers prescribed atthe time of discharge from the hospital. This reduction waseven greater than the 22 percent reduction found in a meta-analysisof 23 trials.10 Furthermore, all subgroups of patients had similarreductions in mortality in the present study.
Nonetheless, only 34 percent of patients were discharged witha prescription for beta-blockers. Low-risk patients were morelikely to be treated with beta-blockade, but nevertheless only41 percent of patients with normal ejection fractions receivedbeta-blockers. This finding is consistent with the results ofprevious studies that have shown low rates of use of beta blockersfor young, "ideal" candidates.5 The most severely ill patientswere even less likely to receive beta-blockers. If one assumesa mean reduction of 9.5 deaths per 100 patients with myocardialinfarction in 24 months, more than 19,000 patients could havebeen kept alive had beta-blockers been more widely prescribed.
Non–Q-Wave Infarction
The relative risk of death in patients with non–Q-waveinfarction who were prescribed beta-blockers was markedly decreased.This is important, because the use of beta-blockers in suchpatients has been questioned since the -Blocker Heart AttackTrial found no improvement in survival among patients with nontransmuralinfarction who were given beta-blockers.11 However, this studywas a subgroup analysis performed at a time when the treatmentof non–Q-wave infarction was substantially different frompresent practice. Indeed, the American College of Cardiologyand American Heart Association joint guidelines for the managementof acute myocardial infarction classify the evidence for theuse of beta-blockade in this subgroup as conflicting and possiblyunfavorable.12 The overwhelming evidence from our study, however,suggests that beta-blockade should be part of the treatmentof patients with non–Q-wave infarction.
Older Age
The present study demonstrates that older patients have a greaterabsolute benefit when treated with beta-blockade. Indeed, evenamong those 80 years of age or older, mortality was 32 percentlower when beta-blockers were prescribed. It is thus unfortunatethat the elderly often receive less treatment after a myocardialinfarction than younger patients.13 The present study foundthat only 27 percent of those over 84 years of age receivedbeta-blockers. In a previous study of elderly patients admittedto a nursing home with evidence of a prior myocardial infarction,only 8 percent were receiving beta-blockade. Interestingly,in that study 37 percent of the patients were receiving calcium-channelblockers, which have not been shown to improve survival andmay actually increase mortality.14
There are few studies of older patients, which might explainthe reluctance on the part of many physicians to use these agents.Previous studies, even of elderly patients, have generally limitedanalysis to patients less than 69 or 75 years of age.15 Nevertheless,the results of our study are consistent with those of an analysisof 5332 Medicare patients without relative contraindicationsto beta-blockade.16
Diabetes Mellitus
Diabetic patients treated with beta-blockers had a 36 percentreduction in mortality. The present study supports previouswork demonstrating that patients with diabetes have a worseoutcome after myocardial infarction than those without diabetes.17,18However, physicians have been reluctant to treat diabetic patientswith beta-blockers because of the risk of worsening the diabetesor of masking hypoglycemic symptoms. Although it is true thatblood glucose concentrations may increase with the use of somebeta-blockers,19 our study confirms previous studies that havedocumented the benefit of beta-blockade in patients with diabetesmellitus.20,21 Because of the high mortality rate among diabeticpatients after myocardial infarction, the absolute survivalbenefit is particularly large in this group of patients.
Pulmonary Disease
Patients with a history of chronic obstructive pulmonary diseasehad a high mortality rate but had a risk reduction of 40 percentwith beta-blockade. Even patients with a history of asthma hadlower mortality with beta-blockers, although these might bethe patients under observation who tolerated the drug.
Many physicians withhold beta-blockers from patients with pulmonarydisease because of concern about bronchoconstriction. It istrue that beta-blockers cause bronchoconstriction in patientswith asthma,22 and bronchial hyperresponsiveness has even beenreported in patients with chronic obstructive pulmonary disease.23Indeed, such patients have generally not been evaluated in studiesof beta-blockers because of concern about bronchial hyperresponsiveness.However, the stimuli to hyperresponsiveness in patients withchronic obstructive pulmonary disease may be different fromthose in patients with asthma, and beta-blockade may not causebronchoconstriction in patients with chronic obstructive pulmonarydisease.23 This may be the reason that in a study of 50 patientswith chronic obstructive pulmonary disease who were given esmolol,there was no change in pulmonary function.24
It appears clear that beta-blockers should be tried in patientswith chronic obstructive pulmonary disease who have had myocardialinfarction. It may be necessary in a very few patients to discontinuethe drug because of bronchoconstriction, but the potential benefitappears large enough to warrant this small risk. We did notcompare 1-selective and nonselective drugs. It is possible thatthey may have different effects on mortality because 1-selectivedrugs have less pulmonary effect.25
Congestive Heart Failure
Whether beta-blockers should be given to patients with bothcongestive heart failure and myocardial infarction remains controversial.Despite initial concern that the negative inotropic effectsof beta-blockade would be detrimental in patients with heartfailure, recent studies have suggested that the long-term effectsof beta-blockade are beneficial.26,27,28 However, patients withischemic cardiomyopathy may not fare as well,29 and many studiesof heart failure have evaluated patients with nonischemic cardiomyopathy.
There are no randomized studies evaluating the effects of beta-blockersin patients with recent myocardial infarction and poor cardiacfunction. In one retrospective analysis, propranolol was effectivein patients with a history of congestive heart failure,30 butthe sickest patients have traditionally been excluded from studies.
The present analysis suggests that patients with the poorestcardiac function benefit as much as patients with better function.Patients with congestive heart failure had a 40 percent reductionin mortality when they received beta-blockers. The relativerisk of death decreased by 40 percent in patients with an ejectionfraction between 20 percent and 49 percent and by 32 percentin patients with an ejection fraction below 20 percent. However,since patients with the lowest ejection fractions have the highestmortality rate, the absolute benefit for these patients is actuallygreater than for those with higher ejection fractions. The estimatesof ejection fraction are obtained by various methods and shouldnot be considered precise. They do show, however, that patientscan benefit from beta-blockade regardless of their ejectionfraction.
Low-Risk Patients
The risks of a drug could conceivably be greater than the benefitsin relatively healthy patients. Indeed, the recommendationsof the American Heart Association for the treatment of myocardialinfarction state that "there is continued debate about whetherlow-risk subjects . . . should be treated with -adrenoceptorblockers because their long-term prognosis is extremely favorableirrespective of such therapy."12 In the present study, however,the lowest-risk subgroups had a decrease in mortality of 40percent with beta-blockade. These subgroups included patientswith normal ejection fractions, patients with low serum creatinineconcentrations, and those who had undergone revascularizationor thrombolysis.
Randomized studies of beta-blocker therapy were performed inthe prethrombolytic era, raising the question of whether beta-blockersare beneficial in patients who have undergone reperfusion.31Previous smaller analyses of patients receiving thrombolyticagents have not clearly shown a long-term effect on mortality.For example, immediate use of beta-blockers did not improvelong-term survival in the II-B substudy of the Thrombolysisin Myocardial Infarction trial.32 We found a decrease in mortalityof 40 percent with the use of beta-blockers in this low-risksubgroup.
Because of their lower mortality rates, the absolute benefitis not as great in members of low-risk subgroups, but beta-blockerssubstantially improved survival in these patients. The questionposed by the American College of Cardiology and American HeartAssociation guidelines for the treatment of patients with acutemyocardial infarction appears to have been answered, at leastwith respect to the predominantly elderly patients analyzedin the present study.
Race
Black patients with hypertension do not respond as well as whitesto treatment with beta-adrenergic blockers.33,34 The reasonsare unknown, but they may be related to differences in beta-adrenoceptorsensitivity.35 This difference has aroused concern that blacksmay not benefit from beta-blockade after myocardial infarction.In contrast to the -Blocker Heart Attack Trial, which foundsimilar benefits in whites and blacks,36 the benefit in blacksappeared to be lower in the present study. This could be dueto differences in the sympathetic nervous system, differencesin the use of the drugs, or other factors. Nevertheless, itshould be noted that both blacks and whites had decreased mortalityrates when given beta-blockers.
Limitations
Our study was not a randomized, controlled trial, and its conclusionsmust be viewed with important reservations. We could not controlfor characteristics that may influence a physician's decisionto prescribe beta-blockers or the patient's decision to complywith a physician's choice of therapy. It is possible that patientswho received beta-blockers were healthier than patients whodid not or that they differed in some other way that causedthem to have lower mortality. They could have had better physiciansor have received different medications after discharge. Nevertheless,we attempted to control for or study the interactive effectsof most of the known risk factors.
It is also possible that there were a substantial number ofcrossovers between the groups. The data reflect beta-blockeruse at hospital discharge; some patients may have started treatmentlater, and some may have discontinued it. Such an effect, however,would be expected to decrease the power of the study.
The consistency among groups suggests that the results of thepresent analysis reflect the benefit of the intervention. Thepresent analysis also confirms previous studies, but it extendsthe evidence of the benefit of beta-blockade to groups not previouslyevaluated. In contrast to other studies, however, our analysisof a large number of patients did not exclude patients at highestrisk.
This analysis strongly indicates that beta-blockade is an underusedtherapy for patients who have had a myocardial infarction. Despitea decrease in mortality of between 28 and 40 percent, patientsin many subgroups are not being prescribed these drugs. In additionto otherwise healthy patients, those with nontransmural infarction,heart failure, pulmonary disease, and older age are likely tobenefit when given beta-blockers after a myocardial infarction.
Supported by a grant from the Delmarva Foundation for MedicalCare and by the Health Care Financing Administration.
We are indebted to Thomas Marciniak, M.D., and William Oetgen,M.D., for their help and support.
Source Information
From the Department of Medicine and the Department of Epidemiology and Preventive Medicine, University of Maryland School of Medicine, Baltimore.
Address reprint requests to Dr. Gottlieb at the Division of Cardiology, University of Maryland Medical Systems, 22 S. Greene St., Baltimore, MD 21201.
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(2005). Chronic kidney disease as cause of cardiovascular morbidity and mortality. Nephrol Dial Transplant
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Kuhlkamp, V., Seipel, L., Healy, E. C., Bhaskarabhatla, K., Manning, W. J., Wyse, D. G., Van Gelder, I. C., Crijns, H. J.G.M.
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[Abstract][Full Text]
-Blocker Heart Attack Trial found no improvement in survival among patients with nontransmural infarction who were given beta-blockers.11 However, this study was a subgroup analysis performed at a time when the treatment of non–Q-wave infarction was substantially different from present practice. Indeed, the American College of Cardiology and American Heart Association joint guidelines for the management of acute myocardial infarction classify the evidence for the use of beta-blockade in this subgroup as conflicting and possibly unfavorable.12 The overwhelming evidence from our study, however, suggests that beta-blockade should be part of the treatment of patients with non–Q-wave infarction. 
80 years old.