Long-Term Benefit of Primary Angioplasty as Compared with Thrombolytic Therapy for Acute Myocardial Infarction
Felix Zijlstra, Ph.D., Jan C.A. Hoorntje, Ph.D., Menko-Jan de Boer, Ph.D., Stoffer Reiffers, Ph.D., Kor Miedema, Ph.D., Jan Paul Ottervanger, Ph.D., Arnoud W.J. van 't Hof, Ph.D., and Harry Suryapranata, Ph.D.
Background As compared with thrombolytic therapy, primary coronaryangioplasty results in a higher rate of patency of the infarct-relatedcoronary artery, lower rates of stroke and reinfarction, andhigher in-hospital or 30-day survival rates. However, the comparativelong-term efficacy of these two approaches has not been carefullystudied.
Methods We randomly assigned a total of 395 patients with acutemyocardial infarction to treatment with angioplasty or intravenousstreptokinase. Clinical information was collected for a mean(±SD) of 5±2 years, and medical charges associatedwith the two treatments were compared.
Results A total of 194 patients were assigned to undergo primaryangioplasty, and 201 to receive streptokinase. Mortality was13 percent in the angioplasty group, as compared with 24 percentin the streptokinase group (relative risk, 0.54; 95 percentconfidence interval, 0.36 to 0.87). Nonfatal reinfarction occurredin 6 percent and 22 percent of the two groups, respectively(relative risk, 0.27; 95 percent confidence interval, 0.15 to0.52). The combined incidence of death and nonfatal reinfarctionwas also lower among patients assigned to angioplasty than amongthose assigned to streptokinase, with a relative risk of 0.13(95 percent confidence interval, 0.05 to 0.37) for early events(within the first 30 days) and a relative risk of 0.62 (95 percentconfidence interval, 0.43 to 0.91) for late events (after 30days). The rates of readmission for heart failure and ischemiawere also lower among patients in the angioplasty group thanamong patients in the streptokinase group. Total medical chargesper patient were lower in the angioplasty group ($16,090) thanin the streptokinase group ($16,813, P=0.05).
Conclusions As compared with thrombolytic therapy with streptokinase,primary coronary angioplasty is associated with better clinicaloutcomes over five years.
In recent years, the prognosis for patients with acute myocardialinfarction has been improved mainly by timely restoration ofblood flow in the infarct-related coronary artery. Intravenousthrombolytic therapy lowers the early mortality rate by an estimated20 to 30 percent.1,2,3 Primary angioplasty, when performed byexperienced clinicians, restores normal blood flow (grade 3flow, according to the Thrombolysis in Myocardial Infarction[TIMI] classification) in 80 to 95 percent of patients.4,5,6,7,8This result compares favorably with the 50 to 70 percent ofpatients in whom normal flow is restored after thrombolytictherapy.3,5,9 Publication of the results of three randomizedtrials4,5,6 prompted a debate about the benefits and limitationsof these two treatments,10,11 but the discussion has been hamperedby a lack of data on long-term follow-up. A recent analysisof data pooled from 10 randomized trials confirmed that duringthe first weeks after an acute myocardial infarction, the ratesof death, nonfatal reinfarction, and stroke are lower afterprimary angioplasty than after thrombolytic therapy.12
Therefore, three questions about primary angioplasty shouldbe resolved before it can be considered the most efficacioustherapy for patients with evolving myocardial infarction. Doesthe higher rate of patency of the infarct-related coronary arteryresult in a more favorable clinical outcome during long-termfollow-up? Is the survival benefit sustained? What is the rateof morbidity due to coronary artery disease during long-termfollow-up? We addressed these questions in a study of 395 patientsrandomly assigned to treatment with primary angioplasty or intravenousstreptokinase and followed for a mean (±SD) of 5±2years.
Methods
The research protocol was reviewed and approved by our institutionalreview board. Patients were enrolled if they had no contraindicationsto thrombolytic intervention; had symptoms of acute myocardialinfarction lasting longer than 30 minutes, accompanied by anelectrocardiogram with ST-segment elevation of more than 1 mm(0.1 mV) in two or more contiguous leads; and presented within6 hours after the onset of symptoms, or within 6 to 24 hoursafter the onset of symptoms if there was evidence of continuingischemia.5 The clinical description of these patients and theshort-term results of the study have been reported previously.5,7,13With rare exceptions, the study population consisted of a consecutiveseries of patients, since the majority of patients who presentedto our hospital with acute myocardial infarction accompaniedby ST-segment elevation agreed to participate.14 From August1990 through April 1993, all presenting patients were askedto participate,5,7,14 and thereafter patients with marked hemodynamicinstability or electrocardiographic signs of extensive infarctionwere excluded, as previously described in detail.13 Enrollmentended in April 1995. Base-line characteristics, clinical data,angiographic data, and outcomes were recorded in a dedicateddata base.
Randomization and Treatment
After informed consent had been obtained, patients were randomlyassigned to undergo primary coronary angioplasty or to receivestreptokinase. All the patients received aspirin and heparin.Patients randomly assigned to the streptokinase group received1.5 million units intravenously over a one-hour period. Patientsrandomly assigned to the angioplasty group were immediatelytransported to the catheterization laboratory; if the coronaryanatomy was suitable for angioplasty, the procedure was performedimmediately, with standard techniques. Global left ventricularejection fraction was measured by equilibrium radionuclide ventriculographybetween days 4 and 10 after treatment.5 Coronary angiographywas performed during follow-up in all patients to assess theextent to which the patency of the infarct-related artery wasmaintained, as previously described.7,8 For purposes of thisstudy, patency in the angioplasty group was defined as grade3 blood flow (according to the TIMI classification) after theangioplasty procedure and on follow-up angiograms. In the streptokinasegroup, patency was also defined as TIMI grade 3 blood flow asassessed by coronary angiography.8 In the latter group, an initial,conservative approach of watchful waiting after treatment wasfollowed by elective coronary angiography. For all the patients,additional revascularization procedures were performed if indicatedfor symptoms or signs of myocardial ischemia.15,16
Follow-up information was obtained in September 1998. All outpatientreports were reviewed, and general practitioners were contactedby telephone. For patients who had died or who had had clinicalevents during follow-up, hospital records were reviewed. Allsubsequent hospital admissions (for angina, recurrent infarction,additional intervention, or heart failure) and medications usedduring follow-up were recorded. Nonfatal recurrent myocardialinfarction was defined as the combination of chest pain, changesin the ST-T segment, and a second increase in the serum creatinekinase level to more than two times the upper limit of normal.If the creatine kinase level had not decreased to normal values,a second increase of more than 200 U per liter over the previousvalue was regarded as indicating a recurrent infarction.5 Allelectrocardiograms and laboratory results were reviewed forevidence of recurrent ischemia by two cardiologists who wereunaware of the treatment assignments.5
Medical Charges
Medical charges were calculated on the basis of estimated unitcharges for all aspects of medical care — namely, daysspent in the hospital (for standard care, coronary care, orpostoperative intensive care), diagnostic and therapeutic procedures,and medications (including thrombolytic drugs given as the studytreatment). Data were collected for the initial admission, readmissions,and visits to the outpatient clinic. Unit charges for proceduresand hospital days were calculated on the basis of hospital recordsfor 1992. These included professional charges and were adjustedfor increased charges on nights or weekends. Charges per patientfor diagnostic catheterization were $716; for angioplasty, $3,818;and for bypass surgery, $8,591. Charges for one day on a generalward were $238; for one day in the coronary care unit, $740;and for one day in the postoperative intensive care unit, $1,074.The charge for streptokinase was $191. Charges for additionalpharmacologic treatment were based on the average charges in1992 for the various drugs, including pharmacy charges. Chargesper patient per month were estimated as follows: for aspirin,$5; for nitrates, $9; for diuretics, $15; for warfarin, $16(including coagulation tests); for antiarrhythmic drugs, $17;for beta-blockers, $28; for calcium-channel blockers, $34; forangiotensin-converting–enzyme inhibitors, $50; and forcholesterol-lowering drugs, $64. This method has been describedpreviously.17
Statistical Analysis
The outcomes assessed were death and the combined incidenceof death and nonfatal reinfarction.
In univariate analyses we investigated the association betweenthese study outcomes and the following risk factors: left ventricularejection fraction (in quartiles), patency of the infarct-relatedartery, diabetes, age (as a continuous variable), multivesseldisease, treatment assignment (angioplasty vs. streptokinase),infarct location (anterior vs. other), presence or absence ofprevious myocardial infarction, time from onset of symptomsto admission, and sex. Multivariate analyses included infarctlocation, left ventricular ejection fraction, age, and sex.
All outcomes were analyzed according to the intention-to-treatprinciple. Differences between group means were assessed withthe two-tailed Student's t-test. Chi-square analysis or Fisher'sexact test was used to test differences between proportions.Survival was calculated by the Kaplan–Meier product-limitmethod.18 The Mantel–Cox (or log-rank) test was usedto evaluate differences in survival between the two treatmentgroups. The Cox proportional-hazards regression model was usedfor multivariate analysis.19 Left ventricular ejection fractionwas included as a categorized variable (in quartiles). Statisticalsignificance was considered to be indicated by a two-tailedP value of less than 0.05. Relative risks were calculated with95 percent confidence intervals.
Results
Of the 395 patients enrolled, 194 were randomly assigned toundergo primary angioplasty and 201 to receive streptokinase.According to the results of angiography at base line, 9 patientsin the angioplasty group were treated conservatively, and 7were referred for urgent coronary-artery bypass grafting; theother 178 patients underwent angioplasty. One patient in thestreptokinase group died before the infusion could be started;the other 200 patients received streptokinase. The clinicalcharacteristics of the two groups are shown in Table 1. Thegroups were similar with regard to age, sex, infarct location,and the presence or absence of a previous myocardial infarction,multivessel coronary artery disease, and diabetes mellitus.Patency of the infarct-related vessel was analyzed in all patientswho survived to the time of follow-up angiography: 191 patientsin the angioplasty group and 196 in the streptokinase group.The infarct-related coronary artery was patent in a greaterproportion of patients in the angioplasty group (90 percent)than in the streptokinase group (65 percent, P<0.001). Theleft ventricular ejection fraction was measured before dischargeby radionuclide imaging in 189 patients in the angioplasty groupand 188 patients in the streptokinase group. The proportionof patients with a left ventricular ejection fraction of lessthan 40 percent was higher in the streptokinase group (26 percent)than in the angioplasty group (14 percent, P=0.006).
Table 1. Base-Line Characteristics of Patients Assigned to Angioplasty or Streptokinase for Acute Myocardial Infarction.
Patients were followed for a mean of 5±2 years, and onlyone patient was lost to follow-up (after 1.5 years). A totalof 74 patients died, 21 from a proven noncardiac cause. Mortalityand causes of death are shown in Table 2. There were 26 deathsin the angioplasty group (13 percent) and 48 in the streptokinasegroup (24 percent) (relative risk of death for patients in theangioplasty group, 0.54; 95 percent confidence interval, 0.36to 0.87). There was a very strong relation between the leftventricular ejection fraction (in quartiles) and the incidenceof death due to cardiac causes. The rate of death from cardiaccauses was 23 percent for patients with a left ventricular ejectionfraction of less than 43 percent, 10 percent for those withan ejection fraction of 43 to 49 percent, 6 percent for thosewith an ejection fraction of 50 to 55 percent, and 4 percentfor those with an ejection fraction greater than 55 percent.
Table 2. Mortality and Causes of Early and Late Death.
Nonfatal reinfarction occurred in 56 patients: 12 in the angioplastygroup (6 percent) and 44 in the streptokinase group (22 percent)(relative risk, 0.27; 95 percent confidence interval, 0.15 to0.52). In the first 30 days after enrollment, there was 1 nonfatalreinfarction (0.5 percent) in the angioplasty group as comparedwith 19 (9 percent) in the streptokinase group (relative risk,0.06; 95 percent confidence interval, 0.01 to 0.40). After 30days, there were 11 reinfarctions (6 percent) in the angioplastygroup as compared with 25 (12 percent) in the streptokinasegroup (relative risk, 0.05; 95 percent confidence interval,0.02 to 0.85). All 20 reinfarctions that occurred within thefirst 30 days affected the same region of myocardium as theindex infarction. Of the 36 reinfarctions that occurred afterday 30 (15 during the first year of follow-up and 21 thereafter),20 involved the original infarct-related coronary artery, and16 involved another coronary artery. The 16 events that involvedanother artery were equally distributed between the two groups(8 in each). The difference in the rate of reinfarction wastherefore due entirely to events that affected the index infarct-relatedcoronary artery.
The combined incidence of death and nonfatal reinfarction waslower in the angioplasty group than in the streptokinase groupduring the first 30 days (relative risk, 0.13; 95 percent confidenceinterval, 0.05 to 0.37) and after 30 days (relative risk, 0.62;95 percent confidence interval, 0.43 to 0.91). Kaplan–Meiercurves for overall survival and for survival free of reinfarctionare shown in Figure 1 and Figure 2.
Figure 1. Kaplan–Meier Curves for Overall Survival in the Angioplasty and Streptokinase Groups during Follow-up.
The rate of survival was higher in the group of 194 patients assigned to undergo angioplasty than in the group of 201 assigned to receive streptokinase.
Figure 2. Kaplan–Meier Curves for Survival Free of Reinfarction in the Angioplasty and Streptokinase Groups during Follow-up.
The rate of survival free of reinfarction was higher in the group of 194 patients assigned to undergo angioplasty than in the group of 201 assigned to receive streptokinase.
The results of multivariate analysis of various characteristicsin relation to death and to the combined incidence of deathand nonfatal reinfarction are shown in Table 3.
Table 3. Multivariate Analyses of Risk Factors for Death from Cardiac Causes and for the End Point of Death or Nonfatal Reinfarction.
Data on additional revascularization procedures are shown inTable 4. Within the first 30 days, angioplasty was performedmore often in the streptokinase group than was a second angioplastyin the angioplasty group. After 30 days, the need for angioplastywas similar in the two groups. There were no significant differencesbetween the groups in the need for early coronary-artery bypassgrafting (within 30 days) or late grafting (after 30 days).
Table 4. Need for Additional Revascularization Procedures.
The use of medication at the end of the follow-up period isshown in Table 5. Warfarin, nitrates, and diuretics were usedsignificantly more frequently by patients assigned to streptokinase.The use of aspirin, statins, beta-blockers, angiotensin-converting–enzymeinhibitors, and other cardiac medications was similar in thetwo groups of patients. During the follow-up period, 74 patientsin the angioplasty group were readmitted to the hospital, witha total of 115 readmissions, as compared with 104 patients anda total of 221 readmissions in the streptokinase group (P<0.001). There were 101 readmissions for ischemia in the angioplastygroup, as compared with 180 in the streptokinase group (P<0.001).There were 14 readmissions for heart failure in the angioplastygroup, as compared with 41 in the streptokinase group (P<0.001).The New York Heart Association class was determined on the basisof information obtained from the patients' general practitioners.Of the patients in the angioplasty group who were alive at theend of follow-up, 149 were in class I, 17 in class II, and 1in class III, as compared with 113, 33, and 8, respectively,in the streptokinase group (P for trend <0.001).
Table 5. Use of Medications at the End of Follow-up.
The total medical charges per patient at the end of the follow-upperiod, including the initial hospital stay, readmissions, procedures,physicians' charges, and medications, were $16,090 for patientsassigned to angioplasty and $16,813 for patients assigned tostreptokinase (P=0.05). The total charges per patient for thosewho were alive at the end of follow-up were $18,664 in the angioplastygroup and $21,772 in the streptokinase group (P=0.008).
Discussion
This study shows that primary angioplasty, as compared withintravenous streptokinase therapy, results in lower mortalityand reinfarction rates both within the first 30 days and duringlong-term follow-up. The risk of death from cardiac causes isstrongly associated with the left ventricular ejection fractionas well as with whether there is early and sustained patencyof the infarct-related coronary artery. Readmission for heartfailure, the use of medications associated with poor left ventricularfunction, and New York Heart Association class as assessed bythe patients' general practitioners also suggest that left ventricularfunction is better preserved with primary angioplasty than withstreptokinase. Although angioplasty is initially more expensivethan thrombolytic therapy, long-term follow-up shows that angioplastyresults in comparatively lower charges, mainly because of amarked decrease in hospital readmissions for ischemia afterangioplasty.
The primary goal of all reperfusion therapies is rapid and completereopening of occluded coronary arteries. This concept has beenconfirmed by the results of the Global Utilization of Streptokinaseand Tissue Plasminogen Activator for Occluded Coronary Arteriestrial.9 Coronary patency, defined as the restoration of normalblood flow in the infarct-related vessel, preserves myocardialtissue and results in improved survival. Patency rates achievedwith primary angioplasty cannot currently be obtained with thrombolyticagents.4,5,6,8,9 Indeed, our data indicate that the higher patencyrate among patients assigned to angioplasty, as compared withthose assigned to streptokinase, resulted in a higher left ventricularejection fraction, a lower incidence of reinfarction, and improvedsurvival. These findings suggest that thrombolytic agents oradjunctive therapies that would result in a higher rate of earlyand sustained TIMI grade 3 flow might offer a similar benefit.
Successful primary angioplasty may also improve the long-termclinical outcome by reducing the incidence of reocclusion ofthe infarct-related artery to less than 10 percent,8 as comparedwith reocclusion rates of up to 30 percent after successfulreperfusion by thrombolytic agents.20 With regard to this differencein the rate of reocclusion, it should be realized that, especiallyduring the first year after the acute coronary event, reinfarctionsare generally related to the artery that was initially occludedand associated with infarction. This is in accordance with theconcept that coronary angioplasty has a plaque-sealing effect.21
The use of the left ventricular ejection fraction as an endpoint in trials of acute myocardial infarction has been controversial.22,23Some investigators have reported that early reperfusion limitsinfarct size and results in superior left ventricular function,9thereby improving long-term survival.24,25 Our data confirmthat higher rates of early and sustained patency of the infarct-relatedvessel are associated with superior left ventricular function.This association is probably due in part to the influence ofsuccessful reperfusion on left ventricular remodeling.26
Heart failure is a common cause of hospitalization and death,and the rates of admission and death due to heart failure, unlikethose due to ischemic heart disease, are increasing and arepredicted to continue to increase.27,28 A recent survey of general-practicesettings shows that myocardial infarction is an important riskfactor for the subsequent development of left ventricular dysfunctionand clinical signs of heart failure.29 In this regard, our findingthat the rate of admission for heart failure was lower amongpatients assigned to undergo angioplasty than among those assignedto receive streptokinase is of clinical importance. Togetherwith the differences in the use of medication and in functionalstatus at the end of follow-up, which favored the angioplastygroup, this finding suggests that the higher left ventricularejection fraction in the angioplasty group before the initialhospital discharge helped preserve long-term ventricular function.The greater use of warfarin and diuretics by patients in thestreptokinase group is probably related to the poorer left ventricularfunction in this group, since diuretics are used for heart failureand warfarin for severely depressed ventricular function oraneurysms. The use of nitrates is related to the occurrenceof angina in daily life. If we take into consideration the largenumber of patients who were hospitalized for treatment of heartfailure or ischemic events or for additional revascularizationprocedures, the number of patients who received beta-block-ersand angiotensin-converting–enzyme inhibitors is probablytoo low for optimal secondary prevention in both groups.30 Optimalprevention of a second myocardial infarction seems to be difficultto accomplish in general practice,31 and although use of thesedrugs is becoming more widespread, there are still many missedopportunities for prevention of reinfarction after an initialinfarction.32
Some limitations of our study should be noted. A trial comparingangioplasty with pharmacologic reperfusion therapy cannot beblinded. Furthermore, in contrast to multicenter trials thathave included thousands of patients undergoing reperfusion therapyfor acute myocardial infarction,1,2,9 our study included only395 patients from a single institution. During enrollment ofthe patients in our study, intracoronary stents and abciximabwere not used. Both additional therapeutic options may havea considerable effect on the clinical outcome in patients withischemic syndromes.33,34 Finally, our cost analysis is basedon estimated charges rather than actual charges.
Supported by a grant (92.321) from the Netherlands Heart Foundation.
We are indebted to the many general practitioners in our regionfor their speedy referral of patients with acute myocardialinfarction and for their superb assistance in obtaining follow-upinformation, and to Vera Derks for expert secretarial assistance.
Source Information
From the Departments of Cardiology (F.Z., J.C.A.H., M.-J.B., J.P.O., A.W.J.H., H.S.), Nuclear Medicine (S.R.), and Clinical Chemistry (K.M.), Hospital De Weezenlanden, Zwolle, the Netherlands.
Address reprint requests to Dr. Zijlstra at the Department of Cardiology, Hospital De Weezenlanden, Groot Wezenland 20, 8011 JW Zwolle, the Netherlands, or at v.derks{at}diagram-zwolle.nl.
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