Background There is no therapy known to reduce the risk of complicationsor death after coronary bypass surgery. Because platelet activationconstitutes a pivotal mechanism for injury in patients withatherosclerosis, we assessed whether early treatment with aspirincould improve survival after coronary bypass surgery.
Methods At 70 centers in 17 countries, we prospectively studied5065 patients undergoing coronary bypass surgery, of whom 5022survived the first 48 hours after surgery. We gathered dataon 7500 variables per patient and adjudicated outcomes centrally.The primary focus was to discern the relation between earlyaspirin use and fatal and nonfatal outcomes.
Conclusions Early use of aspirin after coronary bypass surgeryis safe and is associated with a reduced risk of death and ischemiccomplications involving the heart, brain, kidneys, and gastrointestinaltract.
First performed nearly four decades ago, surgical revascularizationof the coronary arteries is now performed in nearly 1 millionpatients annually — and its growth is likely to accelerate,given the aging of the world population and the increasing availabilityof this therapy in India and China.1,2,3 Although there havebeen substantial advances in surgical technique,4,5 myocardialpreservation,6,7 and hemodynamic monitoring and intensive care,8complication rates continue to be troubling — especiallyfor older and sicker patients and those in whom percutaneousinterventions have failed. In fact, these high-risk patientsnow represent the majority of patients who undergo bypass surgery,giving rise to rates of 15 percent or higher8 for complicationsthat affect not only the heart,9,10 but also the brain,11,12the kidneys,13 and the intestines.14,15 Furthermore, these complicationshave largely gone unchecked, since no preventive therapy hasbeen identified.
It is known that reperfusion of vital organs — achievedmedically or by percutaneous or surgical intervention —is associated with an intense inflammatory response,16,17 precipitatingcell and platelet activation and adherence to disrupted vascularendothelium, intravascular thrombosis, and eventually, organischemia and infarction.18 Consequently, therapies that facilitatethe inhibition of cell activation and adhesion, attenuationof the release of complement and cytokines, and blockage ofcalcium entry into the cell have been sought,19,20,21 albeitwith limited success, for patients undergoing surgical revascularization.Although antiplatelet therapy is now a mainstay of primary andsecondary prevention in patients with acute and chronic cardiovasculardisease,22,23,24 this therapy has not been considered for usein surgical patients, except in the improvement of late vein-graftpatency.25,26 Concern about bleeding has been paramount andhas resulted in the preoperative discontinuation of aspirintherapy, the abrupt reversal of antithrombotic therapy,27,28,29,30and even the active use of antifibrinolytic agents to promoteclotting during the early reperfusion period.31 Furthermore,thrombocytopenia and platelet dysfunction are common immediatelyafter surgical reperfusion,32,33,34,35 leading clinicians tosurmise that any additional interference with platelet functionwould be ineffective, if not unsafe.30,32,33,34,35
To address these issues, we conducted a prospective study todetermine the incidence of fatal and nonfatal ischemic eventsinvolving the heart, brain, kidneys, and gastrointestinal tractafter coronary bypass surgery and to assess the effect on theseoutcomes of aspirin use immediately after revascularization.
Methods
Study Design
The Multicenter Study of Perioperative Ischemia EpidemiologyII Study was prospective and longitudinal, including 5436 patientsadmitted with coronary artery disease that was refractory tomedication who were scheduled to undergo coronary-artery bypasssurgery at one of 70 medical institutions in 17 countries inNorth America, South America, Europe, the Middle East, and Asia.Enrollment began in November 1996 and ended in June 2000; thedata base was locked on October 15, 2001. After approval hadbeen obtained from the institutional review board at each institutionand written informed consent had been obtained from the patients,100 patients were to be prospectively enrolled at each institutionaccording to a systematic sampling scheme: given N = the numberof patients expected to undergo coronary-artery bypass graftingover a one-year period and R = N ÷ 50 (to the closestinteger), every Rth patient meeting the entry criteria was enrolled.If the Rth patient did not meet the criteria, then the nextpatient scheduled for coronary-artery bypass grafting was chosen,and so on. To be eligible for enrollment, the patient had tobe scheduled to undergo coronary-artery bypass grafting withthe use of cardiopulmonary bypass, had to be able to completethe preoperative interview, could not be enrolled in anotherstudy or a clinical trial, and had to give written informedconsent.
Study Data
For each enrolled patient, data on approximately 7500 variableswere collected by independent investigators during the courseof the hospitalization for coronary-artery bypass grafting (theindex hospitalization), and treating physicians were blindedto the research data. Data were adjudicated centrally, withall data for each patient examined for completeness and accuracybefore the data base was closed.
Measurement of Outcomes
All outcomes were prespecified, defined by the protocol, anddetermined by investigators who were unaware of the treatment-groupassignment. Fatal and nonfatal outcomes occurring more than48 hours after surgery and during the index hospitalizationwere classified as cardiac (myocardial infarction or heart failure),cerebral (stroke or encephalopathy), renal (dysfunction or failure),gastrointestinal (ischemia or infarction), or other (e.g., adverseevents) complications. A diagnosis of myocardial infarction36was made if there were either new Q waves (Minnesota code 1-1-1to 1-2-7); new persistent ST-segment or T-wave changes (Minnesotacode 4-1, 4-2, 5-1, 5-2, or 9-2) and elevated values for theMB isoenzyme of creatine kinase; or evidence of acute myocardialinfarction on autopsy. A diagnosis of heart failure36 was madeif a ventricular assist device was used; if continuous inotropicsupport was required for at least 24 hours; or if there wasevidence of heart failure on autopsy. Cerebral outcomes11 wereclassified as clinically diagnosed stroke or encephalopathyor evidence of a focal or global defect on computed tomography,magnetic resonance imaging, or autopsy. Renal dysfunction13was defined by a serum creatinine level of at least 2.0 mg perdeciliter (177 µmol per liter), accompanied by an increaseof at least 0.7 mg per deciliter (62 µmol per liter) frombase line; and renal failure was defined by either renal dysfunctionand dialysis or evidence of renal failure on autopsy. Gastrointestinalischemia15 was defined as abdominal pain most likely associatedwith bowel ischemia or detected on exploration; gastrointestinalinfarction was defined by bowel resection or evidence of intestinalinfarction on autopsy.
Clinical Care and Assessment of Aspirin Use
Clinical decisions were not controlled by the study protocol,and all patients qualifying for enrollment within the prespecifiedperiod were enrolled. Of the 5436 patients enrolled, 371 wereexcluded from the analysis because they withdrew from the study(32 patients), died without having undergone surgery (2 patients),cancelled or rescheduled surgery (97 patients), cancelled coronary-arterybypass grafting with cardiopulmonary bypass during that admission(132 patients), inadvertently enrolled in another study (11patients), had incomplete data (86 patients), or had incompletesampling, shipping, or storage of blood (11 patients). A totalof 5065 patients remained in the analysis, of whom 3001 receivedaspirin (ranging from a total of 80 mg to a total of 650 mg)within 48 hours after revascularization. All medications —including prothrombotic and antithrombotic medications, procoagulantand anticoagulant medications, and blood products — werecharacterized according to day throughout the hospitalization,as well as at admission and at discharge or until death. Allpotential side effects associated with aspirin use, such asblood loss, gastric irritation, infection, and impaired woundhealing, were recorded daily by investigators who were unawareof the treatments received.
Statistical Analysis
A chi-square test was used to compare patients who had receivedaspirin within 48 hours after revascularization with those whohad not received aspirin in terms of the risk of death morethan 48 hours after surgery. Fisher's exact test or a chi-squaretest, as appropriate, was used in the analysis of the risksof individual ischemic outcomes occurring more than 48 hoursafter surgery and involving the heart, the brain, the kidneys,or the gastrointestinal tract (secondary end points), as wellas the risk of combined ischemic outcomes (composite outcome).For these analyses, odds ratios and 95 percent confidence intervalsare reported, with associated P values. All predictor variablesthat were significant at a two-tailed nominal P value of lessthan 0.15 in univariate analyses were then entered into a multivariatelogistic model. Stepwise logistic regression was performed,with variables retained that were significant at a two-tailednominal P value of less than 0.05, with the use of SAS software,version 8.12 (SAS Institute).
Results
Study Patients
Enrolled patients had evidence of chronic or acute cardiovasculardisease, as well as risk factors for or evidence of cerebral,renal, or gastrointestinal disease (Table 1). As expected, therewere small differences between the study groups. Although mostcardiac medications (e.g., beta-blockers, calcium-channel blockers,and angiotensin-converting–enzyme inhibitors) continuedto be administered until the time of surgery, the use of antiplateletmedications was discontinued in 50 percent of patients who hadbeen receiving them at the time of admission to the hospital.
Table 1. Base-Line Demographic and Medical Characteristics of the 5022 Study Patients Who Survived the First 48 Hours.
Adverse Outcomes
A total of 164 of the 5065 patients (3.2 percent) died duringthe index hospitalization, and 100 percent of these deaths wereassociated with one or more adverse ischemic events. Seventy-fourpercent of the deaths (those of 121 patients) and 65 percentof the nonfatal ischemic events (those affecting 530 additionalpatients) occurred at least 48 hours after revascularization.Patients who had received aspirin within 48 hours after revascularizationhad a risk of dying thereafter that was one third that amongpatients who had not received aspirin (1.3 percent vs. 4.0 percent,P<0.001) (Figure 1) and a risk of nonfatal ischemic complicationsinvolving the heart, brain, kidneys, or gastrointestinal tractthat was about 60 percent of that among patients who had notreceived aspirin (9.4 percent vs. 15.4 percent, P<0.001).The reduction in the combined rate of fatal and nonfatal outcomeswas 43 percent (Figure 1). The survival rate was higher throughouthospitalization among those who received aspirin (Figure 2).
Figure 1. Fatal and Nonfatal Ischemic Outcomes among Patients Who Received Aspirin within the First 48 Hours and Patients Who Did Not.
The number of patients at risk varied with the type of outcome, since outcomes occurring within 48 hours after surgery were excluded from the analysis. A total of 73 patients had multiple causes of death.
Figure 2. Kaplan–Meier Analysis of In-Hospital Survival According to the Use or Nonuse of Aspirin within the First 48 Hours among the 5022 Study Patients Who Survived the First 48 Hours after Coronary-Artery Bypass Grafting.
Within 48 hours after surgery, there were 43 deaths —in 2 of the 3001 patients who had received aspirin and 41 ofthe 2064 patients who had not received aspirin. However, tomitigate confounding by indication, none of these deaths wereincluded in the analysis. Multivariate analysis demonstratedthat among all potentially reversible factors, only early aspirinuse was associated with improved survival during the index hospitalization(Table 2). First use of aspirin after 48 hours was not associatedwith a significant reduction in subsequent mortality (27 percentreduction, P=0.42). The beneficial effect of aspirin therapyon fatal outcomes was significant in all subgroups tested, includingthose defined according to individual risk factors for death(such as unstable angina and previous cardiac surgery) and thosedefined according to other factors, such as sex, age (70 yearsvs. <70 years), region (United States, Europe, Asia, Canada,South America, or the Middle East), and type of insurance (government,private, or none). No aspirin dose effect was found for eitherfatal or nonfatal outcomes with total doses of 75 mg, 81 mg,100 mg, 150 mg, 162 mg, 250 mg, or 325 mg. The mean (±SD)length of hospital stay was 9.5±7.1 days among thosewho received aspirin, as compared with 11.5±9.4 daysamong those who did not receive aspirin (P<0.001).
Figure 3. Mortality Associated with Platelet Transfusion (Panel A) and Antifibrinolytic Therapy (Panel B) among Patients Who Received Aspirin and Patients Who Did Not.
Antifibrinolytic therapy entailed the use of aprotinin (in 1578 patients), aminocaproic acid (in 1258 patients), tranexamic acid (in 951 patients), or desmopressin (in 61 patients). There were 189 patients who received more than one of these drugs, and 6 patients had missing data on antifibrinolytic therapy. P values for the pairwise comparisons between subgroups are shown.
Table 3. Aspirin Use and Adverse Events in the 5022 Study Patients.
Discussion
Our findings suggest that aspirin therapy may reduce the frequencyof both fatal and nonfatal outcomes associated with coronarybypass surgery. Aspirin use that was initiated during the first48 hours after revascularization surgery was associated witha 68 percent reduction in overall mortality and similarly substantialreductions in the rates of ischemic complications affectingthe heart (44 percent reduction in fatal and nonfatal myocardialinfarction or congestive heart failure), the brain (62 percentreduction in fatal and nonfatal stroke or encephalopathy), thekidneys (60 percent reduction in renal dysfunction or failure),and the intestines (70 percent reduction in ischemia or infarction).According to multivariate analysis, no other factor, includingany other medication, was associated with reduced rates of theseoutcomes after surgery. Furthermore — and contrary tocurrent belief — aspirin therapy was safe and was notassociated with an increased risk of bleeding, gastritis, infection,or impaired wound healing. Therefore, given the fact that inexpensivegeneric formulations are readily available, our findings supportthe institution of aspirin therapy during the first 48 hoursafter revascularization.
In patients treated medically, the effectiveness of antiplatelettherapy has been demonstrated for both primary and secondaryprevention of complications of cardiovascular disease.22,23,24Despite this evidence, however, clinicians have been reluctantto recommend early antiplatelet therapy for patients undergoingcoronary bypass surgery because of two widely held beliefs —that the platelet concentration is substantially reduced duringsurgery because of sequestration and hemodilution33 and thatplatelet function is markedly impaired during and after surgerybecause of hypothermia37 and mechanical filtering.32,33,34,35Presumably, then, the addition of antiplatelet therapy wouldhave limited benefit and might, in fact, be unsafe.30,32,33,34,35As a result, concern about excessive bleeding — and notabout platelet activation and thrombosis — has dominatedthe thinking of those providing perioperative care, giving riseto the practices of discontinuation of aspirin therapy and thereversal of anticoagulant therapy before surgery,27,28,29,30pervasive use of platelet transfusion during surgery,38,39 andeven the prophylactic use of prothrombotic agents (antifibrinolyticagents) and therapies (clotting-factor transfusion) during thecritical period of reperfusion.31 Unfortunately, few large-scalestudies have attempted to determine either the efficacy or safetyof these practices.
Our findings address a number of these issues and demonstratethat aspirin use in surgical patients is not associated withincreased risk of hemorrhage, gastritis, infection, or impairedwound healing. Regarding efficacy, both the magnitude of theeffect of aspirin and its benefit in multiple organs are noteworthy.Aspirin use was associated with a reduction of 44 to 70 percentin the frequency of major adverse events — that is, atleast twice the reductions reported in studies of primary andsecondary prevention.22,23,24 However, in those studies, patientswere afforded primary protection by beta-adrenergic blockers,angiotensin-converting–enzyme inhibitors, and fibrinolyticagents, effectively diluting the effect of added antiplatelettherapy. Aside from beta-blockade during noncardiac surgery,40these therapies have never been proved effective in surgicalpatients. Therefore, the effects of aspirin as a single therapyare more apparent in this study.
Aspirin also had a broad effect, substantially mitigating bothfatal and nonfatal damage not only to the heart, but also tothe brain, kidneys, and intestines. These findings suggest thatthe platelet has a fundamental role in orchestrating the ischemicresponse to reperfusion injury by multiple organs in patientsundergoing coronary bypass surgery. Three ancillary findingssupport this hypothesis. First, increasing the number of plateletsby transfusion was associated with similar dysfunction of allfour organs, and dysfunction was mitigated nearly uniformlyin all four organs by aspirin therapy. Second, therapies promotingcoagulation, such as transfusion of clotting factors, were associatedwith an increased risk of failure of these organs, which wasalso mitigated nearly equally in these organs by aspirin therapy.Third, medications promoting thrombosis (antifibrinolytic agents,such as aprotinin or aminocaproic acid) were associated withmultiorgan failure, and aspirin therapy had similar benefitin patients who received antifibrinolytic agents and those whodid not (Figure 3B). Thus, not only do these findings supportthe importance of the platelet in patients undergoing coronarybypass surgery — perhaps even suggesting a common finalpathway of injury to multiple diverse organs16 — but theyalso raise concern about practices involving the routine transfusionof platelets or clotting factors38,39 and the widespread useof antifibrinolytic therapy during the critical period of reperfusionin these patients.41
Our study assessed the association between the clinical useof aspirin and outcome, using prospectively defined hypothesesand methods of data collection and analysis. Although patientselection was randomized, treatment-group assignment was not,as it would be in a clinical trial. Therefore, the results maybe biased by differential prescribing of aspirin (confoundingby indication), with sicker patients being less likely to receiveaspirin or healthier patients being more likely to receive aspirin.We addressed this possibility in several ways. First, we comparedpatients who received aspirin within 48 hours after surgerywith those who did not; we did not find any substantive recordeddifferences. Second, we excluded from analysis the 43 deathsthat occurred during the first 48 hours after surgery (2 inpatients who received aspirin and 41 in patients who did not)and the 291 nonfatal complications that occurred during thatperiod (142 in patients who received aspirin and 149 in patientswho did not) and assessed only those outcomes that occurredmore than 48 hours after surgery. Third, in analyzing aspirinuse more than 48 hours after surgery, we assessed the effectof an earlier nonfatal event on subsequent prescribing of aspirinand found only a minor effect: although subsequent aspirin usewas less frequent among those with early adverse events thanamong those without such events (76 percent vs. 84 percent),the effect of the early use of aspirin on the risk of fataland nonfatal events was nearly identical in these two groups(53 percent vs. 51 percent). Most important, multivariate analysesdemonstrated that aspirin use within 48 hours after surgerywas a significant predictor of survival after 48 hours, andits effect was independent of the occurrence or nonoccurrenceof a previous nonfatal event, continuation or discontinuationof aspirin before surgery, and prescribing patterns after 48hours. We conclude that although there may have been confoundingby indication, such bias would have affected only a small proportionof patients and had no substantive effect on our findings.
The size of the effect of aspirin was unexpected: it was quitemarked as compared with that reported in secondary-preventiontrials (odds reductions of 15 to 47 percent).22,23 Unlike patientstreated in secondary-prevention trials in which aspirin is addedto a regimen of other proven therapies, thus diluting its effect,our patients were not offered such therapies, for none havebeen proved effective in patients undergoing coronary bypasssurgery. The only exception for surgical patients is perioperativebeta-adrenergic blockade with atenolol, and the effectivenessof this drug has been demonstrated only in patients undergoingnoncardiac surgery.40 We recognize, however, that our findingsmay overestimate the effect that might be achievable in clinicalpractice. Finally, our findings with regard to bleeding areconsistent with more recent studies addressing preoperativeaspirin use38,39 and probably reflect the benefit of a shorterhospital stay with fewer postoperative interventions (such ascatheterization and use of a ventricular assist device) in aspirin-treatedpatients.
Aspirin therapy, given within 48 hours after revascularization,was associated with reduced rates of death and ischemic complicationsinvolving the heart, brain, kidneys, and gastrointestinal tract.Given the safety, widespread availability, and minimal costof aspirin therapy, our data suggest that early aspirin therapymay be considered for patients undergoing coronary bypass surgeryunless its use is specifically contraindicated.
Supported by the Ischemia Research and Education Foundation.
* The investigators and centers participating in this study arelisted in the Appendix.
Source Information
From the Ischemia Research and Education Foundation, San Francisco.
Address reprint requests to Dr. Mangano at the Editorial Office, Ischemia Research and Education Foundation, 250 Executive Park Blvd., Ste. 3400, San Francisco, CA 94134, or at dtb{at}iref.org.
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Appendix
The following institutions and persons coordinated the MulticenterStudy of Perioperative Ischemia Epidemiology II: Study Chairman— D. Mangano; Senior Editor — L. Saidman; SeniorHematologist — J. Levin; Study Design and Analysis Center,Ischemia Research and Education Foundation — P. Barash,C. Dietzel, A. Herskowitz, C. Ley, P. Hsu, D. Kardatzke, S.Wang, I.C. Tudor; Editorial and Administrative Group —D. Beatty, B. Xavier, S. Kerkela.
The following institutions and persons participated in the study:United States: University of Chicago, Weiss Memorial Hospital— S. Aronson; Beth Israel Hospital, Boston — M.Comunale; Massachusetts General Hospital — M. D'Ambra;University of Rochester — M. Eaton; Baystate Medical Center— R. Engelman; Baylor College of Medicine — J. Fitch;Duke Medical Center — K. Grichnik; University of TexasHealth Science Center at San Antonio–Audie Murphy VeteransAffairs and University Hospital — C.B. Hantler; St. Luke's–RooseveltHospital — Z. Hillel; New York University Medical Center— M. Kanchuger, J. Ostrowski; Stanford University MedicalCenter — C.M. Mangano; Yale University School of Medicine— J. Mathew, M. Fontes, P. Barash; University of Wisconsin— M. McSweeney, R. Wolman; University of Arkansas forMedical Sciences — C.A. Napolitano; Discovery Alliance— L.A. Nesbitt; Veterans Affairs Medical Center, Milwaukee— N. Nijhawan; Texas Heart Institute, Mercy Medical Center— N. Nussmeier; University of Texas Medical School, Houston— E.G. Pivalizza; University of Arizona — S. Polson;Emory University Hospital — J. Ramsay; Kaiser FoundationHospital — G. Roach; Thomas Jefferson University Hospital,Medical College of Pennsylvania–Hahnemann University Hospital— N. Schwann; Veterans Affairs Medical Center, Houston— S. Shenaq; Maimonides Medical Center — K. Shevde;Mt. Sinai Medical Center — L. Shore-Lesserson, D. Bronheim;University of Michigan — J. Wahr; University of Washington— B. Spiess; Veterans Affairs Medical Center, San Francisco— A. Wallace; Austria: University of Graz — H. Metzler;Canada: University of British Columbia — D. Ansley, J.P.O'Connor; Toronto Hospital — D. Cheng; Laval Hospital,Quebec — D. Côte; Health Sciences Centre–Universityof Manitoba — P. Duke; University of Ottawa Heart Institute— J.Y. Dupuis, M. Hynes; University of Alberta Hospital— B. Finnegan; Montreal Heart Institute — R. Martineau,P. Couture; St. Michael's Hospital, University of Toronto —D. Mazer; Colombia: Fundacion Clinico Shaio — J.C. Villalba,M.E. Colmenares; France: Centre Hospitalier RégionalUniversitaire Le Bocage — C. Girard; Hospital Pasteur— C. Isetta; Germany: Universität Würzburg —C.A. Greim, N. Roewer; Universität Bonn — A. Hoeft;University of Halle — R. Loeb, J. Radke; WestfalischeWilhelms–Universität Munster — T. Mollhoff;Universität Heidelberg — J. Motsch, E. Martin; Ludwig-Maximilians-Universität— E. Ott, P. Ueberfuhr; Universität Krankenhaus Eppendorf— J. Scholz, P. Tonner; Georg-August UniversitätGöttingen — H. Sonntag; Hungary: Orszagos KardiologiaiIntezet — A. Szekely; India: Escorts Heart Institute —R. Juneja; Apollo Hospital — G. Mani; Indonesia: NationalCardiac Center — E. Siregar; Israel: Hadassah UniversityHospital — B. Drenger, Y. Gozal, E. Elami; Italy: SanRaffaele Hospital, Universita de Milano — C. Tommasino;Mexico: Instituto Nacional de Cardiologia — P. Luna; theNetherlands: University Hospital Maastricht — P. Roekaerts,S. DeLange; Poland: Institute of Cardiology — R. Pfitzner;Romania: Institute of Cardiology — D. Filipescu; Thailand:Siriraj Hospital — U. Prakanrattana; United Kingdom: GlenfieldHospital — D.J.R. Duthie; St. Thomas' Hospital —R.O. Feneck; the Cardiothoracic Centre, Liverpool — M.A.Fox; South Cleveland Hospital — J.D. Park; SouthhamptonGeneral Hospital — D. Smith; Manchester Royal Infirmary— A. Vohra; Papworth Hospital — A. Vuylsteke, R.D.Latimer.
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70 years vs. <70 years), region (United States, Europe, Asia, Canada, South America, or the Middle East), and type of insurance (government, private, or none). No aspirin dose effect was found for either fatal or nonfatal outcomes with total doses of 75 mg, 81 mg, 100 mg, 150 mg, 162 mg, 250 mg, or 325 mg. The mean (±SD) length of hospital stay was 9.5±7.1 days among those who received aspirin, as compared with 11.5±9.4 days among those who did not receive aspirin (P<0.001). 
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