Coronary Stenting plus Platelet Glycoprotein IIb/IIIa Blockade Compared with Tissue Plasminogen Activator in Acute Myocardial Infarction
Albert Schömig, M.D., Adnan Kastrati, M.D., Josef Dirschinger, M.D., Julinda Mehilli, M.D., Ullrich Schricke, M.D., Jürgen Pache, M.D., Stefan Martinoff, M.D., Franz-Josef Neumann, M.D., Markus Schwaiger, M.D., for The Stent versus Thrombolysis for Occluded Coronary Arteries in Patients with Acute Myocardial Infarction Study Investigators
Background Prevention of myocardial damage is the main goalof all reperfusion therapies in patients with acute myocardialinfarction. The relative efficacy of various reperfusion strategiesis under intensive investigation. We assessed whether coronarystenting combined with the blockade of platelet glycoproteinIIb/IIIa receptors produces a greater degree of myocardial salvagethan fibrinolysis with an accelerated infusion of alteplase,a tissue plasminogen activator.
Methods A total of 140 patients were enrolled in the randomizedtrial; 71 were assigned to receive a stent plus abciximab, and69 to receive intravenous alteplase. The primary end point wasthe degree of myocardial salvage, determined by means of serialscintigraphic studies with technetium Tc 99m sestamibi. Thesecondary end point was a composite of death, reinfarction,and stroke within six months after randomization.
Results In the group that received a stent plus abciximab, themedian size of the final infarct was 14.3 percent of the leftventricle (25th and 75th percentiles, 6.8 and 24.5 percent),as compared with a median of 19.4 percent (25th and 75th percentiles,7.9 and 34.2 percent) in the alteplase group (P=0.02). Thisdifference was due to the larger salvage index (the percentageof the left ventricle that was salvaged, divided by the percentagethat was compromised by the initial perfusion defect) in thestent group: 0.57 (25th and 75th percentiles, 0.35 and 0.69),as compared with 0.26 (25th and 75th percentiles, 0.09 and 0.61;P<0.001). The cumulative incidence of death, reinfarction,or stroke at six months was lower in the stent group than inthe alteplase group (8.5 vs. 23.2 percent, P=0.02; relativerisk, 0.34; 95 percent confidence interval, 0.13 to 0.88).
Conclusions In patients with acute myocardial infarction, coronarystenting plus abciximab leads to a greater degree of myocardialsalvage and a better clinical outcome than does fibrinolysiswith a tissue plasminogen activator.
Patients with acute myocardial infarction benefit markedly fromthe restoration of coronary blood flow in the infarct-relatedvessel, and myocardial salvage is the principal mechanism ofthis benefit.1 The unequivocal demonstration of the advantagesof early fibrinolysis in patients with acute myocardial infarction2,3led to the widespread use of this reperfusion strategy. Subsequently,randomized trials indicated that primary percutaneous transluminalcoronary angioplasty (PTCA) may be superior to fibrinolysiswith regard to the early4,5,6 and late7,8 clinical outcomes.However, the only randomized study that specifically assessedmyocardial salvage found a small but nonsignificant differencein favor of primary PTCA as compared with fibrinolysis.9 Onthe other hand, registry studies have called into question thesuperiority of primary PTCA in general clinical practice.10,11Because of these inconclusive findings and the broader availabilityof fibrinolysis, this strategy is actually the most common therapyfor patients with acute myocardial infarction who present withST-segment elevation within the first 12 hours after the onsetof symptoms.12
Coronary stenting is superior to conventional PTCA for the majorityof patients with stable or unstable angina pectoris,13 and coronarystenting is playing an increasing part in the treatment of patientswith acute myocardial infarction.14,15,16 Blockade of plate-let glycoprotein IIb/IIIa receptors with abciximab has improvedthe outcome of patients with acute myocardial infarction17,18as well as those with stable or unstable angina19 who are undergoingpercutaneous coronary interventions. The combination of stentingand abciximab is effective in improving both epicardial bloodflow20 and microcirculation,18 which, in turn, may increasethe extent of myocardial salvage in patients with acute myocardialinfarction.
We conducted a randomized trial to assess whether stenting combinedwith blockade of glycoprotein IIb/IIIa receptors leads to agreater degree of myocardial salvage and better clinical outcomein patients with acute myocardial infarction than fibrinolysiswith an accelerated infusion of alteplase, a recombinant plasminogenactivator.
Methods
Patients
The study was conducted between December 1997 and August 1999.Patients eligible for this study were those who presented within12 hours after the onset of symptoms, had chest pain for atleast 20 minutes, and had ST-segment elevation of at least 0.1mV in two or more limb leads or at least 2 mV in two or morecontiguous precordial leads on the surface electrocardiogram.We excluded patients who had a recent history of stroke (withinthree months), those with active bleeding or bleeding diathesis,those with a recent history of trauma or major surgery (withina month), those with suspected aortic dissection, those withnoncompressible vascular punctures, those receiving oral anticoagulanttherapy with coumarin derivatives, and those with severe, uncontrolledhypertension (defined as a systolic blood pressure of more than180 mm Hg that was unresponsive to therapy). The study protocolwas approved by the institutional ethics committee.
Study Protocol
After providing informed consent, patients who fulfilled theentry criteria were randomly assigned to one of the treatmentstrategies — intravenous fibrinolysis or coronary stentingplus abciximab — according to a computer-generated randomizationscheme. All patients received 500 mg of aspirin and 5000 U ofheparin intravenously in the emergency room. Immediately afterrandomization but before the initiation of the assigned therapy,patients received an intravenous injection of 27 mCi (1000 MBq)of technetium Tc 99m sestamibi. Single-photon-emission computedtomography was performed within six to eight hours after theinjection of the radionuclide. A follow-up scintigraphic studywas scheduled to be performed approximately 10 days after treatment.
Patients assigned to intravenous fibrinolysis received a bolusdose of 15 mg of alteplase (Actilyse, Boehringer Ingelheim,Ingelheim, Germany) followed by a 90-minute infusion in which0.75 mg per kilogram of body weight (maximal dose, 50 mg) wasgiven over a period of 30 minutes, followed by 0.5 mg per kilogram(maximal dose, 35 mg) over a period of 60 minutes. They alsoreceived intravenous heparin for a period of 48 hours; the initialdose was 1000 U per hour, and the dose was adjusted to achievean activated partial-thromboplastin time between 60 and 85 seconds.A regimen consisting of 100 mg of aspirin twice a day was givenindefinitely.
Placement of coronary stents in patients assigned to this treatmentstrategy was carried out according to our previously describedmethod.21 The stent implanted was the Multi-link stent (Guidant,Advanced Cardiovascular Systems, Santa Clara, Calif.). Duringthe intervention the patients received an additional dose of2500 U of heparin intraarterially as well as abciximab (ReoPro,Lilly Deutschland, Bad Homburg, Germany), given as a bolus of0.25 mg per kilogram followed by a continuous infusion at arate of 10 µg per minute for 12 hours. Postinterventionalantithrombotic therapy consisted of ticlopidine, given at adose of 250 mg twice a day for four weeks, and aspirin, givenat a dose of 100 mg twice a day indefinitely.
Radionuclide Studies
Multihead camera systems with low-energy, high-resolution collimatorswere used for the radionuclide studies. Images were acquiredin a 64-by-64 matrix with an acquisition time of 40 secondsper image. Dedicated software was used to generate transverseslices. A volumetric sampling tool was applied to create polarmaps of the relative distribution of activity throughout theleft ventricle.22 Each polar map was adjusted for its own maximalvalue. The size of the defect was calculated with the use ofa threshold of 50 percent, which was derived from studies thatused a phantom, according to previously described methods.23,24This method allowed us to calculate the following: the percentageof the left ventricle that was compromised by the initial perfusiondefect; the size of the infarct (as a percentage of the leftventricle) at the time of follow-up scintigraphy; the degreeof myocardial salvage (as a percentage of the left ventricle),calculated as the size of the initial perfusion defect minusthe final size of the infarct; and the salvage index, calculatedas the percentage of the left ventricle that was salvaged, dividedby the percentage that was compromised by the initial perfusiondefect.
All measurements were performed in the scintigraphic core laboratoryby operators who were unaware of the patients' assigned therapy.The mean (±SD) intraobserver and interobserver variationsin the measurement of the size of the defect in this laboratorywere 2±3 percent and 2±3 percent of the left ventricle,respectively.
Angiographic Evaluation
In patients assigned to the stent group, initial and postproceduralflow in the infarct-related artery was graded according to theThrombolysis in Myocardial Infarction (TIMI) classification.Digital angiograms were analyzed off line in the angiographiccore laboratory with an automated edge-detection system (CMS,Medis Medical Imaging Systems, Nuenen, the Netherlands).
Study End Points and Definitions
The primary end point of the study was the salvage index. Thesecondary end point was a composite of death, reinfarction,and stroke within six months after randomization. The diagnosisof infarction was based on the findings of typical chest pain,new ST-segment changes, and an increase in the creatine kinaselevel of at least 50 percent over the trough level measuredin at least two samples in which levels were at least 240 Uper liter. The diagnosis of stroke required confirmation bycomputed tomography or magnetic resonance imaging of the head.
Other adverse events recorded were revascularization of thetarget vessel because of ischemia and major bleeding complications.Revascularization of the infarct-related artery through PTCAor coronary-artery bypass grafting was performed when symptomsor signs of ischemia were present when the patient was at restor during exercise. A major bleeding complication was definedas any bleeding that caused hemodynamic compromise or requiredblood transfusion.
Levels of creatine kinase and its MB isoenzyme, hemoglobin levels,and the platelet count were determined before and 8, 16, and24 hours after the treatment and daily thereafter until discharge.After discharge, the patients' clinical status was determinedby means of a telephone interview at 30 days and a follow-upvisit at 6 months or whenever a patient reported having symptoms.
Statistical Analysis
The number of patients included in the study was based on theestimation of the sample size needed to identify a significantdifference in the primary end point. In a pilot study of primarystenting in patients with acute myocardial infarction, we foundthat the average salvage index was 0.55±0.28. Assumingthat the salvage index would be 0.40 in the fibrinolysis group,we estimated that 60 patients would be required in each groupfor the study to have a power of 80 percent to detect an absolutedifference in the salvage index of 0.15 with a two-sided valueof 0.05.25 We allowed for the possibility that scintigraphicstudies would be incomplete in some patients by including atotal of 140 patients.
All analyses were performed according to the intention-to-treatprinciple. The data are presented as medians (with the 25thand 75th percentiles) or as counts or proportions. The differencesbetween the groups were assessed with use of a two-sided chi-squaretest or Fisher's exact test for categorical data and the nonparametricWilcoxon rank-sum test for continuous data. Survival was analyzedaccording to the Kaplan–Meier method. The relative riskof adverse events during the first six months after randomizationwas derived from proportional-hazards regression analysis. Differencesin survival were also assessed for significance by means ofthe log-rank test. A two-tailed P value of less than 0.05 wasconsidered to indicate statistical significance.
Results
Of the 140 patients enrolled, 71 were randomly assigned to undergostenting and receive abciximab and 69 to receive intravenousalteplase. Only one patient in the stent group did not receivethe assigned therapy; in this patient, the occluded left anteriordescending artery opened during injection of the contrast medium,and no angiographically significant residual stenosis was visible.Table 1 shows the base-line characteristics of the two groups.Killip class 3 or 4 was found at presentation in 8.4 percentof the patients in the stent group and 2.9 percent of thosein the alteplase group (P=0.29). There was no significant differencebetween groups in the time from the onset of symptoms to admission,but there was a significant delay in providing the assignedtherapy in the stent group. There were no significant differencesbetween the groups in the proportions of patients who were receivingconcomitant medications. Table 2 shows the initial and postproceduralangiographic characteristics of the patients who were assignedto undergo coronary stenting. Antegrade blood flow was fullyrestored (TIMI flow grade 3) in 95.8 percent of the patientswho received a stent plus abciximab.
Table 2. Angiographic Characteristics of the 71 Patients in the Stent Group at Base Line and after Stenting.
Myocardial Salvage
The initial radionuclide study could not be performed in sixpatients in the stent group and seven in the alteplase groupbecause of hemodynamic instability or for technical reasons.Of the six such patients in the stent group, three died soonafter the procedure (one on day 1, one on day 3, and one onday 5), two underwent the follow-up radionuclide study (finalinfarct size, 29.7 percent and 3.0 percent of the left ventricle),and one did not undergo the follow-up study. Of the seven suchpatients in the alteplase group, three died soon after receivingthe fibrinolytic therapy (two on day 1 and one on day 3), twounderwent the follow-up radionuclide study (final infarct size,20.9 percent and 15.7 percent of the left ventricle), and theother two did not undergo the follow-up study. Of the 127 patientswho underwent the initial radionuclide study, 2 patients ineach group did not undergo the follow-up study. Thus, 63 patientsin the stent group (88.7 percent) and 60 patients in the alteplasegroup (87.0 percent, P=0.75) underwent both the initial andthe follow-up radionuclide studies that were required for thecalculation of the primary end point. Only three of the patientsin the stent group and four in the alteplase group underwentrevascularization of the infarct-related artery between theinitial and follow-up radionuclide studies.
Table 3 shows the results of scintigraphy. Although the sizeof the initial perfusion defect was similar in the two groups,the final size of the infarct was significantly smaller amongpatients in the stent group than among those in the alteplasegroup (14.3 percent vs. 19.4 percent of the left ventricle,P=0.02). This difference was the result of a greater degreeof myocardial salvage in the stent group (16.1 percent vs. 7.4percent of the left ventricle, P<0.001). Therefore, the primaryend point of the trial — the salvage index — wassignificantly greater with stenting than with alteplase (0.57vs. 0.26, P<0.001).
Three patients in the stent group (4.2 percent) and five inthe alteplase group (7.2 percent) died during the first 30 daysafter randomization. There were also two cases of nonfatal reinfarctionsamong patients in the stent group and four cases among patientsin the alteplase group. Thus, the composite end point of death,reinfarction, or stroke at 30 days was reached in five patientsin the stent group (7.0 percent) and nine patients in the alteplasegroup (13.0 percent). One patient in each group required urgentcoronary-artery bypass grafting during this period. Major bleedingcomplications were observed in three patients in the stent groupand two in the alteplase group.
At six months, the incidence of death, reinfarction, or stroke(no cases of stroke were observed during follow-up) was 8.5percent in the stent group, as compared with 23.2 percent inthe alteplase group (relative risk, 0.34; 95 percent confidenceinterval, 0.13 to 0.88) (Figure 1). The cumulative incidenceof death during this period was 4.2 percent in the stent groupand 13.0 percent in the alteplase group (relative risk, 0.31;95 percent confidence interval, 0.08 to 1.16). Revascularizationof the infarct-related artery was needed in 10.0 percent ofthe patients in the stent group and 34.9 percent of the patientsin the alteplase group (relative risk, 0.24; 95 percent confidenceinterval, 0.11 to 0.57).
Figure 1. Kaplan–Meier Estimates of the Cumulative Incidence of Death, Reinfarction, or Stroke during the First Six Months after Randomization.
The log-rank test was used to calculate the P value.
The primary and secondary end points were also analyzed in severalsubgroups. These results are given in Figure 2 and show theconsistency of scintigraphic and clinical findings among thesubgroups.
Figure 2. Differences in the Salvage Index and the Relative Risk of Death, Reinfarction, or Stroke at Six Months in the Stent Group as Compared with the Alteplase Group, According to Various Characteristics.
Horizontal bars indicate the 95 percent confidence intervals.
Discussion
Our findings demonstrate that primary stenting combined withabciximab therapy results in a significantly greater degreeof myocardial salvage than does fibrinolysis with an acceleratedinfusion of alteplase in patients with acute myocardial infarction.Although the base-line characteristics were similar in the twogroups, patients who underwent stenting had a smaller finalinfarct size and a lower risk of major adverse clinical eventsduring the six months after the primary treatment.
We used a sensitive, reliable, and practical technique to assessthe degree of myocardial salvage. Because of its insignificantredistribution26 after initial extraction, 99mTc-sestamibi canbe injected before the reperfusion treatment and imaging canbe postponed until after the treatment, avoiding any delay inthe treatment of patients with acute myocardial infarction.The accuracy of this method for the assessment of both the sizeof the initial defect and the size of the infarct after reperfusionhas been validated in several studies.23,27 The use of myocardialsalvage as an end point in reperfusion trials is being advocatedbecause of its potential prognostic value.28,29
The base-line characteristics of the patients in the alteplasegroup were representative of those treated with fibrinolysisin recent reperfusion trials, except for a slightly greaterproportion of patients in Killip class 4 in our population.The 30-day mortality rate of 7.2 percent among the patientstreated with alteplase is within the range of 6.2 to 7.5 percentreported in previous clinical trials of the same fibrinolyticagent.6,30,31,32,33 The size of the initial perfusion defectis also similar to that quantified in the randomized trial conductedby Gibbons et al.9 The use of alteplase in that study led, however,to a greater degree of myocardial salvage than in our study.Two factors may account for this difference. First, the characteristicsof the patients may have differed, since none of the patientsenrolled in the fibrinolysis group in the study by Gibbons etal.9 died during the six-month follow-up period. Second, 21of the 56 patients (38 percent) who were assigned to fibrinolysisin the study by Gibbons et al.9 underwent angioplasty of theinfarct-related vessel during hospitalization, a procedure thatmay have increased the degree of myocardial salvage, which wasassessed before discharge.
In our study, patients assigned to stenting had base-line clinicalcharacteristics that were similar to those of patients in thealteplase group. The 30-day mortality rate (4.2 percent) didnot differ significantly from that of 3.5 percent reported ina recent comparison of stenting with PTCA.34 In our patients,most of whom had an initial TIMI flow grade of 0 or 1, stentingplus blockade of platelet glycoprotein IIb/IIIa receptors wasassociated with the full restoration of antegrade blood flow(TIMI grade 3) in 96 percent. This value is 6 percentage pointshigher than that achieved recently with primary stenting withoutfibrinogen-receptor blockade.34 Similar results in favor ofabciximab use were also recently reported.20 In addition, abciximabalso substantially improves flow in the microvascular bed,18in part because of its antiinflammatory effect of interferingwith platelet–leukocyte interactions.35
At six months, the clinical results favored the combinationof stenting with abciximab. Parallel to the benefit in clinicaloutcome at six months was the significantly greater degree ofmyocardial salvage after stenting plus platelet glycoproteinIIb/IIIa blockade in this trial. Although assessing myocardialsalvage with 99mTc-sestamibi scintigraphy is very attractive,supportive evidence of its value in prognosis from clinicaltrials with mortality as an end point is still lacking.28 However,the advantages afforded by increasing the extent of myocardialsalvage take time to become clinically apparent, because ofthe persistence of myocardial stunning with reperfusion therapy.36On the basis of our findings, a new reperfusion strategy suchas combining stenting with abciximab yields a significantlygreater degree of myocardial salvage and a better clinical outcomeat six months than does a conventional strategy of fibrinolytictherapy in patients with acute myocardial infarction.
This trial had sufficient statistical power only to assess myocardialsalvage. Therefore, the difference observed in clinical outcomeneeds to be confirmed by larger trials.
We compared a combined strategy of stenting plus abciximab withalteplase alone; we do not know how much of the benefit canbe ascribed to stenting and how much to fibrinogen-receptorblockade. The extent of the benefit appears to be greater thanthat observed in prior comparisons of tissue plasminogen activatorwith percutaneous coronary interventions without the adjunctiveuse of platelet glycoprotein IIb/IIIa blockade for myocardialinfarction. Therefore, abciximab may have contributed importantlyto our results. The promotion of embolization by either fibrinolytictherapy or catheter-based reperfusion therapy has recently beenunderscored as a major problem in the treatment of acute myocardialinfarction; this problem can largely be surmounted by adjunctiveblockade of glycoprotein IIb/IIIa receptors.37 Our study wasdesigned before the announcement of the results of the TIMI14 trial, which showed that the addition of abciximab to intravenoustherapy with tissue plasminogen activator increased the rateof successful flow restoration.38 Therefore, further studiesare needed to test whether this combined regimen also leadsto a greater degree of myocardial salvage than fibrinolytictherapy alone.
Our results were achieved at institutions with high volumesof interventional procedures. Therefore, these results may notbe directly applicable to the entire medical community responsiblefor treating patients with acute myocardial infarction. Theymay be helpful, nonetheless, in designing future treatment guidelinesfor these patients.
Supported in part by grants from the Technische UniversitätMünchen in Munich, Boehringer Ingelheim Pharma in Ingelheim,and Lilly Deutschland, Bad Homburg, Germany.
We are indebted to the members of the medical and technicalstaffs in the coronary care units, nuclear medicine, and catheterizationlaboratories of the participating institutions for their invaluablecontribution and to Kurt Ulm, Ph.D., for his expert statisticaladvice.
* The investigators participating in the study are listed in theAppendix.
Source Information
From the Deutsches Herzzentrum (A.S., A.K., J.D., J.M., S.M.), the 1. Medizinische Klinik rechts der Isar (A.S., J.P., F.-J.N.), and the Klinik und Poliklinik für Nuklearmedizin rechts der Isar (U.S., M.S.), Technische Universität, Munich, Germany.
Address reprint requests to Dr. Schömig at Deutsches Herzzentrum, Lazarettstr. 36, 80636 Munich, Germany, or at aschoemig{at}dhm.mhn.de.
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Appendix
The following investigators participated in the Stent versusThrombolysis for Occluded Coronary Arteries in Patients withAcute Myocardial Infarction (STOPAMI) Study: Steering Committee— A. Schömig (chairman), M. Schwaiger (cochairman),A. Kastrati, J. Dirschinger, F.-J. Neumann; Data CoordinatingCenter — A. Kastrati, U. Schricke, M. Hadamitzky, H. Kreuzberg;Scintigraphic Core Laboratory — U. Schricke, S. Martinoff,J. Neverve, D. Wetzel, S. Nekolla; Angiographic Core Laboratory— J. Mehilli, A. Redl, H. Bollwein; Clinical Follow-upCenter — J. Pache, D. Hall, H. Holle, K. Hösl, K.Stein, F. Albrecht, M. Ibrahim; Clinical Investigators —F.-J. Neumann, E. Alt, M. Seyfarth, H. Schühlen, J. Dirschinger,R. Blasini, C. Schmitt, M. Gawaz, N. von Beckerath.
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value of 0.05.25 We allowed for the possibility that scintigraphic studies would be incomplete in some patients by including a total of 140 patients. 
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