Background When administered in conjunction with primary coronarystenting for the treatment of acute myocardial infarction, aplatelet glycoprotein IIb/IIIa inhibitor may provide additionalclinical benefit, but data on this combination therapy are limited.
Methods We randomly assigned 300 patients with acute myocardialinfarction in a double-blind fashion either to abciximab plusstenting (149 patients) or placebo plus stenting (151 patients)before they underwent coronary angiography. Clinical outcomeswere evaluated 30 days and 6 months after the procedure. Theangiographic patency of the infarct-related vessel and the leftventricular ejection fraction were evaluated at 24 hours and6 months.
Results At 30 days, the primary end point — a compositeof death, reinfarction, or urgent revascularization of the targetvessel — had occurred in 6.0 percent of the patients inthe abciximab group, as compared with 14.6 percent of thosein the placebo group (P=0.01); at 6 months, the correspondingfigures were 7.4 percent and 15.9 percent (P=0.02). The betterclinical outcomes in the abciximab group were related to thegreater frequency of grade 3 coronary flow (according to theclassification of the Thrombolysis in Myocardial Infarctiontrial) in this group than in the placebo group before the procedure(16.8 percent vs. 5.4 percent, P=0.01), immediately afterward(95.1 percent vs. 86.7 percent, P=0.04), and six months afterward(94.3 percent vs. 82.8 percent, P=0.04). One major bleedingevent occurred in the abciximab group (0.7 percent); none occurredin the placebo group.
Conclusions As compared with placebo, early administration ofabciximab in patients with acute myocardial infarction improvescoronary patency before stenting, the success rate of the stentingprocedure, the rate of coronary patency at six months, leftventricular function, and clinical outcomes.
Coronary stenting and antiplatelet therapy both play an importantpart in interventional cardiology,1,2,3 and the emergence anddevelopment of both therapies have been closely associated.4,5,6,7The combination of ticlopidine and aspirin enhances the benefitof coronary stenting by reducing acute stent thrombosis, andnew agents such as platelet glycoprotein IIb/IIIa inhibitors8limit ischemic complications in patients undergoing balloonangioplasty9,10,11,12 or stent implantation.13,14 However, despitethe potential link between fibrinogen and restenosis, blockadeof glycoprotein IIb/IIIa has not been shown to alter the frequencyof restenosis as determined by angiography or echocardiography.15,16
There are few data on the use of the combination of stentingand glycoprotein IIb/IIIa inhibition in patients with acutemyocardial infarction.17,18,19,20 A recent large, randomizedtrial of angioplasty with or without stent implantation showedthat stenting was beneficial in reducing the need for revascularizationbut found no reduction in the rates of death or reinfarction.20In contrast, glycoprotein IIb/IIIa inhibition decreased therate of ischemic events after balloon angioplasty but had noeffect on the need for revascularization at six months.21
This study (conducted by the Abciximab before Direct Angioplastyand Stenting in Myocardial Infarction Regarding Acute and Long-TermFollow-up [ADMIRAL] investigators) was a multicenter, double-blind,randomized trial with broad inclusion criteria, no angiographicselection criteria, and early randomization after presentation,to reflect the common practice of primary stenting in patientswith acute myocardial infarction. We hypothesized that abciximabfollowed by stenting would be superior to stenting alone.
Methods
Patients
Patients scheduled for primary percutaneous coronary revascularizationwere eligible for enrollment if they were more than 18 yearsold, had had the first symptoms of acute myocardial infarctionwithin 12 hours before enrollment, and had ST-segment elevationof more than 1 mm in at least two contiguous leads of the electrocardiogram.Exclusion criteria were bleeding diathesis, administration ofthrombolytic agents for the current episode, neoplasm, recentstroke, uncontrolled hypertension, recent surgery, oral anticoagulanttherapy, a limited life expectancy, childbearing potential,and known contraindications to therapy with aspirin, ticlopidine,or heparin. There were no angiographic selection criteria. Theethics review board of the Pitié–SalpêtrièreHospital approved the protocol, and the study was conductedin accordance with the Declaration of Helsinki. Written informedconsent was obtained from the patients.
Study Protocol
All the patients received aspirin and were randomly assigned,in the order in which they were enrolled, to receive eitherabciximab or placebo. The study drug was administered immediatelyafter randomization, in the mobile intensive care unit beforearrival at the hospital, in the emergency department, in theintensive cardiac care unit, or in the catheterization laboratory;in all cases it was administered before sheath insertion andcoronary angiography. The patients, investigators, and sponsorsof the study were blinded to the treatment assignments duringthe entire study. Patients received either abciximab (ReoPro,Centocor, Malvern, Pa.) as a bolus of 0.25 mg per kilogram ofbody weight, followed by a 12-hour infusion of 0.125 µgper kilogram per minute (maximum, 10 µg per minute), orplacebo.
Heparin was given as an initial bolus of 70 U per kilogram (maximum,7000 U). If necessary, additional boluses were administeredto achieve an activated clotting time of 200 seconds. Afterpercutaneous coronary revascularization, a continuous infusionof 7 U of heparin per kilogram per hour was initiated and maintaineduntil a coronary angiogram had been obtained, 24 hours afterthe procedure. The target activated partial-thromboplastin timewas between 1.5 and 2.0 times the control value. It was recommendedin the protocol that the investigators stop the administrationof heparin on completion of the 24-hour angiography study andthat they remove the sheaths 4 to 6 hours later. Ticlopidine(250 mg twice daily, without a loading dose) was given for the30 days immediately after stent implantation in both groups.Previously validated treatment algorithms for the managementof bleeding, emergency coronary-artery bypass surgery, and thrombocytopeniawere recommended in the protocol to decrease the likelihoodof hemorrhagic complications.12,13
Catheterization Procedures and Angiographic Analysis
A stent was implanted if the diameter of the infarct-relatedartery was greater than 2.5 mm, without extensive calcificationor unsuitable anatomical features. The first choice was theSaint-Côme stent (Saint-Côme-Chirurgie, Marseilles,France), a balloon-expandable, slotted tube stent, but the investigatorswere permitted to use an alternative stent if necessary.
All the patients who were randomly assigned to one of the twostudy groups were part of the angiographic analysis, which involvedfour coronary angiograms (obtained on admission, at the endof the percutaneous coronary revascularization procedure, and24 hours and 6 months after the procedure). Complete angiographicfollow-up at 6 months was carried out to evaluate the patencyof the target vessel unless the patient had died, had undergonerepeated revascularization, had had an occluded vessel at theend of the procedure or at 24 hours, had not undergone a revascularizationprocedure after the initial coronary angiography (e.g., becausethe rate of flow in the target vessel was classified as grade3 according to the classification of the Thrombolysis in MyocardialInfarction [TIMI] trial and the stenosis was judged to be lessthan 50 percent), or refused angiography at 6 months.
Cineangiograms were obtained according to standard acquisitionguidelines and submitted to an independent core angiographylaboratory, which was not one of the study centers. Analyseswere carried out on a per-lesion basis. Perfusion was gradedaccording to the TIMI classification system. Occlusion and reocclusionwere defined as a TIMI grade 0 or 1 flow in the occluded artery.Left ventricular volumes and ejection fractions were computedaccording to Simpson's rule from two orthogonal right anterioroblique and left anterior oblique views. Computerized quantitativeand qualitative analyses of angiograms were performed (Tagarno35AX Viewing Station, General Electric Medical Systems, Waukesha,Wis., and VIEW NT system with Quantitative Coronary Analysisand Ventricular Analysis software, Electromed InternationalSociety, Quebec, Que., Canada).22,23,24,25,26
End Points
The primary end point was the composite of death, reinfarction,or urgent revascularization of the target vessel at 30 daysafter randomization. The key secondary end point was the compositeof death, reinfarction, or any revascularization (percutaneouscoronary revascularization or coronary-artery bypass graftingon an urgent or elective basis) at 30 days and at 6 months.Other secondary end points were death or reinfarction at 30days and at 6 months; death, reinfarction, or urgent revascularizationof the target vessel at 6 months; the TIMI flow grade before,immediately after, 24 hours after, and 6 months after the revascularizationprocedure; and the left ventricular ejection fraction within24 hours and at 6 months after the revascularization procedure.
Reinfarction was defined according to clinical symptoms andnew electrocardiographic changes with a new elevation of thecreatine kinase or creatine kinase MB isoenzyme levels.12,21Creatine kinase and creatine kinase MB were measured beforethe administration of abciximab or placebo; 8, 16, 24, and 48hours afterward; and whenever reinfarction was suspected. Urgenttarget-vessel revascularization was defined as a repeated coronaryrevascularization procedure or coronary-artery bypass graftingperformed within 24 hours after a new ischemic episode. Episodesof bleeding were defined as major or minor according to theTIMI classification,27 and severe thrombocytopenia was definedby a platelet count of less than 50,000 per cubic millimeter.
Data were collected on case-report forms at the clinical studycenters and checked against medical records. A blinded clinical-eventsadjudication committee evaluated each event related to the primaryend point or the secondary end point. A clinical end-pointsand safety monitoring committee continuously checked and monitoredall adverse events in a blinded manner.
Statistical Analysis
When the study was planned, the incidence of the primary endpoint in the group of patients who were assigned to placebowas expected, according to the findings of observational studies,to be between 13 percent and 20 percent. The minimal samplesize was determined to be 150 patients per group to ensure 80percent power to detect a difference between a placebo groupin which the incidence of events was 15 percent and a treatmentgroup in which the incidence of events was 5 percent, with useof the chi-square test and at a two-sided significance levelof 5 percent. The data were retained by Eli Lilly, where theanalyses were performed. Independent statistical advice wasprovided by E. Vicant (Paris VII University). All analyses wereperformed on an intention-to-treat basis. The rates (percentages)reported for demographic, procedural, efficacy, and safety dataare based on observations in patients with no missing data.The percentages in the two groups were compared with use ofPearson's chi-square test or Fisher's exact test. Kaplan–Meiercurves were constructed for the primary end point at 30 daysand at 6 months. Continuous variables are presented as means±SD and were analyzed with a linear model that includedfixed effects of treatment, the investigator, and their interaction.Analyses among subgroups of the patients were planned in advance.
In a complementary analysis based on multiple logistic-regressionmodels, none of the base-line characteristics (including thediameter of the target coronary artery, the dose of heparin,and the type of stent) were found to have a significant effecton the incidence of the primary end point or the incidence ofdeath, and there was no significant interaction between thesevariables and the treatment effect. Consequently, unadjustedestimates of the relative risk were used in the current analyses.All the tests were two-sided, with significance levels of 5percent and two-sided 95 percent confidence intervals. All thecalculations were performed with SAS statistical software (version6.12, SAS Institute, Cary, N.C.).
Results
Base-Line Characteristics of the Patients
From July 12, 1997, to December 22, 1998, 300 patients withacute myocardial infarction were enrolled at 26 centers. Thetwo study groups were well matched with respect to base-linecharacteristics and key angiographic features (Table 1). Seventy-eightpatients (26 percent) were randomly assigned to one of the twostudy groups early (in the mobile intensive care unit or emergencydepartment), with either abciximab or placebo administered beforeand during transportation to the catheterization laboratory.The other 222 patients were randomly assigned to one of thestudy groups on admission to the intensive cardiac care unitor in the catheterization laboratory. The length of time betweenthe onset of chest pain and coronary angiography did not differamong these sites. The length of time between the onset of chestpain and administration of the bolus of the study drug was shorteramong the patients who received it in the mobile intensive careunit (178±94 minutes) than among those who received itin the emergency department (266±139 minutes, P=0.02)or in the intensive cardiac care unit or catheterization laboratory(238±142 minutes, P=0.002).
Table 1. Base-Line Characteristics of the Patients.
The prevalence of congestive heart failure was similar in thetwo groups, as was the incidence of cardiogenic shock duringthe first 24 hours after randomization. Initial angiographyshowed that the infarct-related vessel was small (referencediameter, <2.5 mm) in 12.5 percent of the patients; smallvessels were more frequently found in the abciximab group thanin the placebo group (18.3 percent vs. 5.9 percent, P=0.006).
After the initial angiogram, percutaneous coronary revascularizationwas attempted in 92 percent of the patients in the abciximabgroup and 95 percent of those in the placebo group; this smalldifference may reflect the more frequent presence of fully openarteries in those who received abciximab. Of the patients whounderwent balloon angioplasty, 92 percent received at leastone stent and 32 percent received more than one stent. The Saint-Cômestent was implanted in 66 percent of the patients who receiveda stent; the others received other stents (XT, Bard, MurrayHill, N.J.; Tenax, Biotronik, Bulak, Germany; NIR and NIR Primo,Boston Scientific, Natick, Mass.; Crossflex, Cordis, Miami;ACS Multi-Link and Duet Guidant, Indianapolis; Jostent, Jomed,Helsingborg, Sweden; and Bestent, GFX, and Wiktor, Medtronic,Minneapolis). Among the patients who received a stent, the incidenceof the primary end point was similar among those in whom a Saint-Cômestent was used and those in whom other stents were used (10.1percent vs. 9.9 percent, respectively; P=0.96). Ticlopidinewas given to 99 percent of the patients who received a stent.Doses of heparin and measurements of anticoagulation were similarin the study groups (activated clotting time, 316 seconds inthe abciximab group vs. 348 seconds in the placebo group; andactivated partial-thromboplastin time, 2.2 vs. 2.4 times thecontrol value, respectively, during revascularization).
Coronary Flow and Left Ventricular Function
The initial proportion of patients with TIMI grade 3 flow wassignificantly higher in the abciximab group than in the placebogroup (Table 2), and the difference between these two groupswas greater when TIMI grades 2 and 3 were considered together(rate in the abciximab group, 25.8 percent, vs. 10.8 percentin the placebo group; P=0.006). After the revascularizationprocedure, the proportion with TIMI grade 3 flow greatly increasedin both study groups and remained higher in the abciximab groupthan in the placebo group. The rate of procedural success (definedas stenosis of <50 percent and TIMI grade 3 flow) was higherwith abciximab than with placebo (95.1 percent vs. 84.3 percent,P=0.01). At six months, the frequency of both TIMI grade 3 flowand of TIMI grade 2 or 3 flow remained higher in the abciximabgroup than in the placebo group (rate of TIMI grade 2 or 3 flow,97.1 percent vs. 87.9 percent; P=0.04), with fewer angiographicallydetected reocclusions with abciximab than with placebo (2.9percent vs. 12.1 percent, P=0.04). At six months, abciximabwas also associated with a higher rate of patency in the subgroupof patients with small arteries (2.5 mm) than was placebo (TIMIgrade 2 or 3 flow, 100 percent vs. 60.0 percent; P=0.02). Abciximabwas associated with a more rapid and persistent improvementin left ventricular ejection fraction (improvement occurringwithin 24 hours and lasting at least 6 months) than placebo(Table 2).
Table 2. TIMI Flow Grades and Left Ventricular Ejection Fraction.
TIMI grade 3 flow at the end of the procedure was strongly relatedto the risk of both the 30-day and the 6-month clinical endpoints. The primary end point at 30 days had occurred in 7.4percent of the patients with TIMI grade 3 flow, as comparedwith 35.3 percent of the patients with TIMI grade 0, 1, or 2flow (P<0.001). This difference persisted at 6 months (P<0.001).Similarly, the incidence of the key secondary end point at 30days and 6 months was significantly lower in the patients withTIMI grade 3 flow than in those with a lower TIMI grade of flow.Moreover, the presence of TIMI grade 3 flow at the end of theprocedure was significantly related to the risk of death withinthe following 30 days or 6 months (6-month mortality, 2.3 percentamong patients with TIMI grade 3 flow, vs. 17.6 percent amongpatients with lower TIMI grades of flow; P=0.001), and abciximabhad a significant effect on this relation (P=0.03). The lowestmortality was seen among the patients who were assigned to abciximaband had TIMI grade 3 flow at the end of the revascularizationprocedure.
Clinical Outcomes
As compared with placebo, abciximab significantly reduced theincidence of the primary end point at 30 days, with a substantialreduction in each of the components of the end point (Table 3);the benefit was mainly observed during the first week afterstent implantation (Figure 1). When analyzed in subgroups accordingto clinical characteristics, most of the subgroups had similarbenefit with abciximab as compared with placebo (Figure 2).The incidence of the key secondary end point was also significantlylower in the abciximab group than in the placebo group at 30days. Episodes of minor bleeding occurred more frequently inthe abciximab group than in the placebo group, mainly in associationwith groin hematomas (Table 3).
Figure 1. Kaplan–Meier Curves Showing the Cumulative Incidence of the Primary End Point at 30 Days and at 6 Months.
The primary end point was the composite of death, reinfarction, and urgent target-vessel revascularization within 30 days after random assignment to treatment with abciximab or placebo. In the abciximab group, there was a 59 percent relative reduction in the risk of the primary end point at 30 days (P=0.01 for the comparison between the two groups) (top panel). At six months, there was a 53 percent reduction in the risk of the primary end point in the abciximab group (P=0.02 for the comparison between the two groups) (bottom panel).
Figure 2. Relative Risks of the Primary End Point at 30 Days and 6 Months, According to Subgroup.
The primary end point was death, reinfarction, or urgent target-vessel revascularization. Asterisks denote a significant difference between the two treatment groups (P<0.05). CI denotes confidence interval, MICU mobile intensive care unit, ER emergency room, ICCU intensive cardiac care unit, and CL catheterization laboratory.
The incidence of the primary end point at six months was significantlylower in the abciximab group than in the placebo group, withan absolute reduction of 8.5 percent (relative reduction, 53percent) and preservation of the early benefit (Figure 1). Anonsignificant, 55 percent reduction in mortality with abciximabas compared with placebo also persisted at six months. A consistentbenefit with abciximab was seen in all the subgroups of patients;the patients who received their randomly assigned treatmentwith abciximab early had a greater benefit with respect to theprimary end point at both 30 days and 6 months than did thosetreated with abciximab in the intensive cardiac care unit orcatheterization laboratory (Figure 2). At six months, the incidenceof the key secondary end point and the rates of target-vesselrevascularization were lower with abciximab than with placebo,suggesting that the drug had an effect on clinical restenosis(Table 3). Patients with diabetes who received abciximab hada significant reduction in the six-month mortality rate as comparedwith patients with diabetes who received placebo (0 percentvs. 16.7 percent, P=0.02), as well as a reduction in the incidenceof death, reinfarction, or any revascularization (20.7 percentvs. 50.0 percent, P=0.02), a reduction in the need for urgenttarget-vessel revascularization (0 percent vs. 12.5 percent,P=0.049), and a reduction in the need for any target-vesselrevascularization (13.8 percent vs. 37.5 percent, P=0.046).
Discussion
The complementary effects of platelet glycoprotein IIb/IIIainhibition and stenting have been previously shown in scheduled(i.e., elective) percutaneous coronary revascularization, butnot in primary revascularization for acute myocardial infarction.The results of this trial show that, as compared with placebo,abciximab therapy initiated before catheterization improvesoutcomes in patients with acute myocardial infarction who aretreated with primary stenting. Abciximab in combination withstent placement reduces both the incidence of acute ischemicevents and the incidence of end points related to clinical restenosis.This study also shows that in comparison with stenting alone,the addition of abciximab (along with aspirin) as a first-linetreatment for acute myocardial infarction more frequently opensthe occluded artery, improves the success of stenting, reducesthe rate of reocclusion, and more frequently restores an optimalflow for up to six months, with concomitant improvements inboth left ventricular ejection fraction and prognosis.
To reflect as closely as possible the real practice of primarypercutaneous coronary revascularization, patients were selectedfor the study only on the basis of typical chest pain with ST-segmentelevation on the electrocardiogram; there were few clinicalexclusion criteria and no angiographic criteria for the selectionof patients. In this high-risk population, the benefits seenwith abciximab are consistent with those in a recent open-labeltrial of stenting that included patients with Q-wave or non–Q-wavemyocardial infarction within 48 hours after the onset of pain.17
The benefit of abciximab, as compared with placebo, was observedeven in specific subgroups of patients with acute myocardialinfarction who are usually excluded from trials of stenting— namely, those with small arteries or with cardiogenicshock. In patients with diabetes, abciximab reduced the six-monthrates of death and clinical restenosis, confirming previousresults in patients undergoing elective stenting.28 Althoughthey constituted a prespecified subgroup, the patients withdiabetes were few in number, and there was no specific stratificationfor diabetes. Therefore, caution is required in the interpretationof these results; whether abciximab has specific effects indiabetic patients remains to be fully explored. In addition,the number of women in the trial was small, and there was inadequatepower to allow us to draw meaningful conclusions about thistherapeutic approach in women.
As with thrombolytic agents,29 the administration of abciximabearly after presentation resulted in a higher initial frequencyof TIMI grade 3 flow than that achieved with placebo. As comparedwith placebo, it led to a better rate of procedural successwith stenting, which translated into a better 24-hour left ventricularejection fraction (a change that may have involved other mechanisms,such as less distal emboli, less side-branch closure,13 or improvementsin microcirculation).17 Treatment during the first few hoursafter acute myocardial infarction is critical to the long-termprognosis,30,31,32,33 and early TIMI grade 3 flow is importantin reducing the risk of death, as shown in the Global Utilizationof Streptokinase and Tissue Plasminogen Activator for OccludedCoronary Arteries (GUSTO) trial.29 The relation found in thecurrent study between the presence of TIMI grade 3 flow andrisk of death at both 30 days and 6 months is consistent withthe idea that platelet glycoprotein IIb/IIIa inhibition helpsboth to achieve coronary-artery patency and to improve the prognosis(and thus supports the "open-artery" hypothesis).
Although low doses of heparin were recommended,12,13 the investigatorsmay have given higher doses in the context of the double-blindstudy design. The activated clotting time or activated partial-thromboplastintime measured during the procedure in the placebo group wasin agreement with a consensus statement34 and recent studiesof stenting.20,35 However, in the abciximab group, these dosesof heparin resulted in excessively high activated clotting times,leading to an increase in the incidence of groin hematomas (whichmay also be related to the use of a sheath that is left in placefor 24 hours). To limit the risk of hematomas with powerfulantiplatelet agents, leaving the sheath in for prolonged periodsmust be strongly discouraged, whereas low doses of heparin andcareful management of the femoral access site are advisable.12Oral antiplatelet therapy in the current study was based onthe ticlopidine regimen that has been tested and approved forstent implantation.5,6,7 Although most intervention centershave recently switched from ticlopidine to clopidogrel withor without a loading dose, recent data showed no differencebetween these two drugs in the prevention of major cardiac events,36and the results presented here probably apply equally to patientsreceiving clopidogrel.
In acute myocardial infarction, the administration of both aspirinand a glycoprotein platelet IIb/IIIa inhibitor at presentationfacilitates acute reperfusion. In addition, we found that arapid and aggressive antiplatelet strategy, in generally unselectedpatients with acute myocardial infarction who were treated withprimary stenting, led to improved outcomes. This strategy isfeasible, effective, and safe. The results thus add supportto the "open-artery" hypothesis with IIb/IIIa inhibition inprimary coronary stenting.
Supported by Eli Lilly, Saint-Cloud, France, and Indianapolis,and by Saint-Côme-Chirurgie, Marseilles, France.
Dr. Pinton is an employee of and stockholder in Eli Lilly. Dr.Montalescot has served as a consultant to Eli Lilly.
We are indebted to Eric Topol, M.D. (Cleveland Clinic Foundation,Cleveland), for expert editorial assistance; to Eric Vicaut,M.D., Ph.D. (Fernand Widal Hospital, Paris), for statisticalassistance; to Valérie Moreau, Isabelle Bouvard, andNathalie Berkani (Eli Lilly, Saint-Cloud, France) for assistancein coordinating the study and for data management and analysis;and to Marcel Mazéas for enthusiastic support in initiatingthe study.
* The members of the ADMIRAL (Abciximab before Direct Angioplastyand Stenting in Myocardial Infarction Regarding Acute and Long-TermFollow-up) study group are listed in the Appendix.
Source Information
From the Division of Cardiology (G.M., R.C.), the Department of Anesthesiology, and the Mobile Intensive Care Unit (P.E.), Pitié–Salpêtrière Hospital, Paris; the Divisions of Cardiology, Beauregard Clinic, Marseilles (P.B.), Des Franciscaines Clinic, Nîmes (O.W.), Lagny–Marne-la-Vallée Hospital, Lagny-sur-Marne (S.E.), Les Fleurs Clinic, Ollioules (P.V.), Saint-Joseph Clinic, Colmar (J.-M.B.), Institut Cardiovasculaire Paris Sud, Antony (M.-C.M.), Trousseau Hospital, Tours (L.M.), and Henri Duffaut Hospital, Avignon (M.P.); and the Cardiovascular Therapeutic Unit, Eli Lilly, Saint-Cloud (P.P.) — all in France.
Address reprint requests to Dr. Montalescot at the Service de Cardiologie, Centre Hospitalier Universitaire Pitié–Salpêtrière, 47 Blvd. de l'Hôpital, 75013, Paris, France, or at gilles.montalescot{at}psl.ap-hop-paris.fr.
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Appendix
The following persons participated in the trial: Trial Organization:Steering Committee: G. Montalescot (chairperson) (Groupe HospitalierPitié–Salpêtrière, Paris), P. Barragan(Clinique Beauregard, Marseilles), and P. Pinton (Eli Lilly,Saint-Cloud); Clinical End Points and Safety Monitoring Committee:A. Leizorovicz (chairperson) (Hôpital Louis Pradel, Lyons),A. Cribier (Hôpital Charles Nicolle, Rouen), and M. MeyerSamama (Hôpital Hôtel Dieu, Paris); Clinical EventsAdjudication Committee: J.L. Dubois Randé (chairperson)(Hôpital Henri Mondor, Créteil), M. Slama (HôpitalAntoine Béclère, Clamart), and K. Boughalem (HôpitalBroussais, Paris); Angiographic Core Laboratory: I. Azancot(chairperson) and V. Stratiev (Hôpital Lariboisière,Paris); Trial Investigators:Pitié–SalpêtrièreHospital, Paris: G. Montalescot, Cardiology Division (42 patientsenrolled), and P. Ecollan, mobile intensive care unit (26);Des Franciscaines Clinic, Nîmes: O. Wittenberg, CardiologyDivision (44), and J.E. De La Coussaye, University Hospitaland mobile intensive care unit (4); Lagny-Marne-la-ValléeHospital, Lagny-sur-Marne: S. Elhadad (28); Les Fleurs Clinic,Ollioules: P. Villain (24); Saint-Joseph Clinic, Colmar: J.M.Boulenc (20); Institut Cardiovasculaire Paris Sud, Antony: M.-C.Morice (18); Trousseau Hospital, Tours: L. Maillard (12); HenriDuffaut Hospital, Avignon: M. Pansieri, Cardiology Division(8), and J. Vaque, mobile intensive care unit (3); Les AlpillesClinic,Marseilles: P. Barragan (10); La Valette Clinic, Montpellier:X. De Boisgelin (10); Centre Hospitalier Intercommunal, Eaubonne-Montmorency,Montmorency: A. Akesbi (8); Pays d'Aix Hospital, Aix-en-Provence:C. Barnay (7); Essey-Les-Nancy Clinic, Essey-Les-Nancy: M. Amor(6) and P.E. Bollaert, Hôpital Central, Nancy, and mobileintensive care unit (1); René Dubos Hospital, Pontoise:F. Funck (5); Boucicaut Hospital, Paris: A. Lafont (4); CentreMedico Chirurgical Obstetrical, Schiltigheim: M. Zupan (4);Hôpital Nord, Marseilles: F. Paganelli (4); Saint-JosephHospital, Marseilles: F. Dhoudain (3); Necker Hospital, Paris:J.P. Metzger (3); Rhône-Durance Clinic,Avignon: J. Sainsous(3); Haut Lévesque Hospital, Pessac: P. Coste (2); andLa Cavale Blanche Hospital, Brest: J.P. Boschat (1) —all in France.
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2.5 mm) than was placebo (TIMI grade 2 or 3 flow, 100 percent vs. 60.0 percent; P=0.02). Abciximab was associated with a more rapid and persistent improvement in left ventricular ejection fraction (improvement occurring within 24 hours and lasting at least 6 months) than placebo (Table 2). 
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