Background Among physicians who treat patients with acute myocardialinfarction, there is controversy about the magnitude of theclinical benefit of primary (i.e., immediate) coronary angioplastyas compared with thrombolytic therapy.
Methods As part of the Global Use of Strategies to Open OccludedCoronary Arteries in Acute Coronary Syndromes (GUSTO IIb) trial,we randomly assigned 1138 patients from 57 hospitals who presentedwithin 12 hours of acute myocardial infarction (with ST-segmentelevation on the electrocardiogram) to primary angioplasty oraccelerated thrombolytic therapy with recombinant tissue plasminogenactivator (t-PA). We also randomly assigned 1012 patients toheparin or hirudin treatment in a factorial design. The primarystudy end point was a composite outcome of death, nonfatal reinfarction,and nonfatal disabling stroke at 30 days.
Results The incidence of the primary end point in the angioplastyand t-PA groups was 9.6 percent and 13.7 percent, respectively(odds ratio, 0.67; 95 percent confidence interval, 0.47 to 0.97;P = 0.033). Death occurred in 5.7 percent of the patients assignedto angioplasty and 7.0 percent of those assigned to t-PA (P= 0.37), reinfarction in 4.5 percent and 6.5 percent (P = 0.13),and disabling stroke in 0.2 percent and 0.9 percent (P = 0.11).At six months, there was no significant difference in the incidenceof the composite outcome (14.1 percent vs. 16.1 percent, P notsignificant). The primary end point was observed in 10.6 percentof the patients in the angioplasty group assigned to heparinand 8.2 percent of those assigned to hirudin (P = 0.37).
Conclusions This trial suggests that angioplasty provides asmall-to-moderate, short-term clinical advantage over thrombolytictherapy with t-PA. Primary angioplasty, when it can be accomplishedpromptly at experienced centers, should be considered an excellentalternative method for myocardial reperfusion.
Prompt, complete restoration of coronary flow is the principalmechanism by which reperfusion therapy improves survival andother clinical outcomes in patients with acute myocardial infarctionin whom there is electrocardiographic evidence of ST-segmentelevation.1,2,3 At selected centers, coronary angioplasty canbe performed expeditiously in such patients, resulting in bettercoronary flow4,5 and 30-day survival rates2,4,5,6,7,8,9,10,11,12than are obtained with intravenous thrombolytic therapy.
Intravenous thrombolytic therapy is, however, the standard ofcare for patients with acute myocardial infarction, becauseof its widespread availability, its ability to reduce mortality,and its use in more than a million patients over the past decade.6,13,14,15Recently, two large studies of registry data16,17 raised doubtabout whether the apparent superiority of angioplasty over thrombolytictherapy would be sustained in general clinical practice, becausetreatment delays and technical failures appear to be more commonthan in the selected centers that have participated in randomizedtrials.
The use of "front-loaded" (accelerated), weight-adjusted treatmentwith recombinant tissue plasminogen activator (t-PA)6 insteadof other lytic regimens used in previous trials4,5,7,8,9,10,11,12might further reduce the differences in outcome between thesetwo therapies. Also, the adjunctive use of direct inhibitorsof thrombin, which have several potential advantages over heparinbut have not been proved beneficial in this setting,18,19 mightalso influence the outcomes of these two strategies. Therefore,we performed an international, multicenter, randomized trialcomparing primary angioplasty with thrombolytic therapy (andhirudin with heparin, in the patients treated with primary angioplasty)in the initial management of acute myocardial infarction.
Methods
Study Organization
This study was a prospective substudy of the Global Use of Strategiesto Open Occluded Coronary Arteries in Acute Coronary Syndromes(GUSTO IIb) trial.20 Fifty-seven hospitals in nine countriesparticipated (see the Appendix). To participate, each site wasrequired to perform at least 200 angioplasties yearly, to haveat least one cardiologist who had performed at least 50 angioplastiesyearly, a 24-hour on-call team, and a system for operating-roombackup if emergency bypass surgery was required. Eighty-fivepercent of sites performed more than 400 angioplasties yearly,and 85 percent of operators performed more than 75 angioplastiesyearly.
Study Patients
Patients presenting within 12 hours after the onset of symptoms(chest pain lasting at least 20 minutes, accompanied by electrocardiographicsigns of ST-segment elevation of at least 0.2 mV in two or morecontiguous leads or left bundle-branch block) were eligiblefor enrollment. The exclusion criteria were identical to thoseused in the main GUSTO IIb trial.20 All the patients gave informedconsent, and the protocol was approved by the institutionalreview board at each hospital.
Randomization and Treatment Strategies
The investigators and study coordinators telephoned or faxeda 24-hour-a-day, seven-day-a-week randomization center to reviewthe eligibility of patients and receive their assignments totreatment. Eligible patients were randomly assigned to eitherprimary coronary angioplasty or accelerated t-PA (an intravenousbolus of 15 mg, followed by an infusion of 0.75 mg per kilogramof body weight [not to exceed 50 mg] over a 30-minute periodand then 0.50 mg per kilogram [not to exceed 35 mg] over thenext 60 minutes, for a maximal total dose of 100 mg). The first1012 patients were also randomly assigned, in a two-by-two factorialdesign, to either heparin or hirudin given intravenously aspart of the GUSTO IIb trial (these patients were included inthe main trial).20 The protocol for the administration of thestudy drug in this trial has been reported previously20; inbrief, patients were assigned to receive an infusion of eitherheparin or hirudin for three to five days; the dose was adjustedto keep the activated partial-thromboplastin time within the60-to-85-second range.
At the recommendation of the Data and Safety Monitoring Boardand the GUSTO IIb Steering Committee, enrollment in this substudywas extended, without a review of the end-point data, beyondthe completion of enrollment in the GUSTO IIb trial, to January1, 1996, in order to reach the intended sample size. All thepatients enrolled thereafter were treated with heparin as thethrombin inhibitor.
All the patients were also to receive standard medical care,including chewable aspirin, at the time of enrollment.20 Othercardiac medications were administered at the discretion of thephysician. Angiography within three days of study entry wasdiscouraged in patients randomly assigned to t-PA, except tomanage refractory ischemia or hemodynamic deterioration.
Primary Angioplasty
Angioplasty was performed according to local standards, withthe intention of reestablishing blood flow in the infarct-relatedartery as soon as possible. After securing arterial access andverifying that angioplasty was indicated, we titrated the studythrombin inhibitor in a double-blind fashion in increments of3000 U of heparin or 30 mg of hirudin to reach an activatedclotting time of at least 350 seconds. The infarct-related arterywas the only target, except in patients whose hemodynamic valuesdeteriorated despite restoration of the patency of that artery.After angioplasty, the study drug was temporarily stopped topermit early removal of the sheath. The study protocol acknowledgedthat in some patients, particularly those with stenoses of theleft main artery or critical three-vessel disease, bypass surgeryshould be strongly considered instead of angioplasty. In patientswhose infarct-related arteries had Thrombolysis in MyocardialInfarction (TIMI) grade 3 flow at first angiography, whetheror not to perform angioplasty was left to the judgment of theoperator.
Angiographic Analyses
The cineangiograms obtained at study entry for all patientsrandomly assigned to angioplasty were forwarded to the AngiographicCore Laboratory for quantitative analyses by a validated edge-detectionmethod (Artrek, version 1.60, Quinton Imaging Systems, Bothell,Wash.).21 Technical success was defined as a residual stenosisof less than 50 percent and a final TIMI flow grade of 2 or3.
Data Management and Quality Assurance
Case-report forms were forwarded to either the internationalcoordinating center (Catholic University, Leuven, Belgium) orthe main coordinating center (Duke University, Durham, N.C.)for data entry and the generation of queries about missing orinconsistent data. Patient follow-up at 30 days and 6 monthswas performed by means of a self-administered questionnaire,telephone interview, or follow-up visit to the physician. Thequality of the data was ensured by auditing 10 percent of thedata forms and by having an independent Clinical Events Committeeadjudicate decisions on all possible primary-end-point events.A data-based algorithm was developed to capture all the eventsthat might constitute part of the primary end point and triggera review of chart information by this committee, whose membersremained unaware of the initial treatment assignments.
End Points
The primary end point was a composite outcome of death, nonfatalreinfarction, and nonfatal disabling stroke within 30 days,as confirmed by the Clinical Events Committee. The prespecifiedsecondary end points were mortality from all causes at 30 days;mortality from all causes and nonfatal reinfarction at 30 days;a composite end point consisting of death, reinfarction, disablingstroke, and congestive heart failure at 30 days; recurrent,medically refractory ischemia; and major bleeding.20 Follow-upelectrocardiograms and creatine kinase and MB isoenzyme levelswere to be obtained at the time of any suspected myocardialreinfarction.20 Computed tomography or magnetic resonance imagingof the brain was requested for all patients with suspected stroke.Severe bleeding was defined as intracranial hemorrhage or bleedingthat caused hemodynamic compromise. Moderate bleeding was definedas bleeding that required blood transfusion but that did notlead to hemodynamic compromise.
Statistical Analysis
The primary study hypothesis was that immediate angioplastywould result in a lower incidence of death, nonfatal reinfarction,and nonfatal disabling stroke at 30 days than thrombolytic therapy.The incidence of the primary end point in the t-PA group wasexpected to be approximately 12 percent. Although studies hadsuggested that the incidence of major end points would be morethan 60 percent lower with angioplasty than with thrombolytictherapy,4,5,7,8,9,10,11,12 the size of this study populationwas chosen to ensure that a relative reduction of 40 percentcould be detected with an alpha error of 0.05 and a beta errorof 0.20.
Continuous data are presented as medians with 25th and 75thpercentiles unless otherwise stated. Selected base-line characteristicsand clinical outcomes were compared between treatment groupsby the chi-square test in the case of discrete variables andby nonparametric analysis of variance in the case of continuousvariables. Odds ratios and 95 percent confidence intervals wereused to compare treatments with regard to major clinical outcomes.KaplanMeier survival curves were used to characterizethe timing of the primary study end point and its componentsduring the follow-up period. Logistic-regression models wereused to assess prespecified interactions.
Prespecified subgroups classified according to the followingvariables were studied in relation to the primary and secondaryend points: age and time to randomization, as continuous variables;and anterior as compared with nonanterior location of the infarct,high as compared with low risk,5 and the hospital's experiencewith angioplasty (with the number of procedures dichotomizedat the median), as discrete variables.
An interim analysis of safety was performed by an independentData and Safety Monitoring Board when the enrollment reached750 patients, as specified in the protocol. Efficacy was comparedwith the use of two-sided, symmetric O'BrienFleming boundariesgenerated by the LanDeMets approach to group-sequentialtesting.22,23 All tests of significance were two-tailed, andthe treatments were compared according to the intention-to-treatprinciple.
Results
Recruitment began on July 5, 1994, and ended on January 1, 1996,after 1138 patients had been enrolled. The patients tended tobe middle-aged and male, presenting without hypotension or pulmonaryedema (Table 1). Among the patients randomly assigned to angioplasty,94 percent had angiography and 82 percent had angioplasty (5percent also received stents); among the patients randomly assignedto t-PA, 98 percent received that therapy and only 1.4 percenthad primary angioplasty. Balloon inflation was first performedin the patients undergoing angioplasty a median of 1.3 hoursafter randomization (interquartile range, 1.0 to 1.6). The activatedpartial-thromboplastin times at 6 hours were longer in the angioplastygroup because of periprocedural dosing to achieve an activatedclotting time of more than 350 seconds, but the times in thetwo groups were similar by 12 hours after the initial drug therapy.
Table 1. Characteristics of the Patients at Base Line, According to Treatment Assignment.
In the patients randomly assigned to angioplasty, 83 percentof the infarct-related arteries were initially occluded (TIMIgrade 0 or 1 flow) according to the on-site interpretation (Table 2).The median peak activated clotting time during the procedurewas 381 seconds (interquartile range, 329 to 480). TIMI grade3 flow was obtained in 73 to 88 percent of the patients (dependingon whether the angiograms were read at the core laboratory orat the site). Seventeen of 465 patients (3.7 percent) who wererandomly assigned to angioplasty and who underwent that procedurerequired bypass surgery on the same day. The results of angioplastydid not differ significantly between the patients assigned toheparin and those assigned to hirudin. The medications receivedduring hospitalization are shown in Table 3.
Table 3. Concomitant Medications and In-Hospital Procedures in the Study Groups.
As compared with t-PA, angioplasty resulted in 13 fewer deaths(95 percent confidence interval, -15 to 41; P = 0.37) and 41fewer deaths, infarctions, or disabling strokes (95 percentconfidence interval, 3 to 78; P = 0.033) at day 30 per 1000patients (Table 4 and Table 5). Most of the relative benefitof angioplasty seemed to occur between days 5 and 10 (Figure 1Aand Figure 1B). Among patients undergoing delayed electiveangioplasty, 7 of 61 (11 percent) in the t-PA group and 2 of5 (40 percent) in the angioplasty group subsequently died orhad a reinfarction or a nonfatal, disabling stroke. Angioplastywas associated with more bleeding events than t-PA, with thenotable exception of intracranial hemorrhage. Death, reinfarction,or disabling stroke occurred in 10.6 percent of patients assignedto angioplasty and heparin, as compared with 8.2 percent ofthose assigned to angioplasty and hirudin (P = 0.37). Bleedingcomplications in the hirudin and heparin groups were similar.
Figure 1. KaplanMeier Curves for Survival (Panel A) and Freedom from the Composite End Point of Death, Reinfarction, and Disabling Stroke (Panel B) in the Study Patients within the 30 Days after Randomization, According to Treatment Group.
Eighteen percent of the patients assigned to angioplasty didnot undergo that procedure. At least 9.3 percent had acceptablereasons for not undergoing primary angioplasty: 1.2 percentdied early, 6.9 percent had an open infarct-related artery,and 1.2 percent had early bypass surgery with left main or three-vesselcoronary disease. Another 3.4 percent had early catheterizationwith no reason noted for refraining from primary angioplasty;3.6 percent did not undergo early catheterization, had receivedthrombolytic therapy before catheterization (often because ofdelays in patient transfer), or both; and for the remaining1.6 percent, information about the time of catheterization wasmissing. Among the patients assigned to primary angioplastywho did not undergo the procedure, 14.1 percent died within30 days and 20.7 percent died or had a nonfatal reinfarctionor nonfatal, disabling stroke.
In the angioplasty group, the correlations between mortalitywithin 30 days and the final TIMI flow grades as determinedin the core laboratory were as follows: TIMI flow grade 0, 21.4percent mortality; grade 1, 14.3 percent; grade 2, 19.9 percent;and grade 3, 1.6 percent (P<0.001).
The relation between the risk of death within 30 days and assignmentto angioplasty or accelerated t-PA in several prospectivelydefined subgroups of patients is shown in Figure 2.
Figure 2. Point Estimates and 95 Percent Confidence Intervals for the Odds Ratios for Death within 30 Days in Several Prospectively Defined Subgroups of Patients, According to Treatment Assignment.
Odds ratios below 1 indicate that angioplasty is preferable, and odds ratios above 1 that thrombolysis is preferable. High-risk patients were those with an anterior infarction, an age of 70 years or older, or a heart rate of 100 beats per minute or higher at admission. The hospitals were subdivided according to the median annual angioplasty caseload (625 angioplasties). The size of the solid squares corresponds roughly to the number of patients studied. Complete data were not available for all the patients.
Six months after randomization, with follow-up complete in 96.9percent of the eligible patients, the incidence of the compositeadverse outcome was 15.7 percent in the t-PA group and 13.3percent in the angioplasty group (P not significant).
Discussion
In this international trial comparing primary angioplasty withthrombolytic therapy for acute myocardial infarction, therewas a relative benefit at 30 days with angioplasty with respectto all elements of the primary study end point death,reinfarction, and disabling stroke. The aggregate outcome occurredsignificantly less often in the angioplasty group in9.6 percent of patients, as compared with 13.7 percent in thet-PA group (odds ratio, 0.67; P = 0.033). The extent of thisbenefit and of the benefit with regard to mortality alone (P= 0.37) was far less than was seen in eight previous, small,randomized trials but larger than in recent data reported fromlarge registries.16,17
Previous randomized trials, albeit with considerable apparentheterogeneity, suggested that there was a significant improvementin major clinical outcomes with angioplasty, with an estimated40 lives saved (95 percent confidence interval, 2 to 63) per1000 patients treated.4,5,7,8,9,10,11,12 This benefit is largerthan the benefit of streptokinase as compared with placebo (inthe Gruppo Italiano per lo Studio della Streptochinasi nell'InfartoMiocardico trial, 23 lives saved at 21 days; in the Second InternationalStudy of Infarct Survival, 29 lives saved at 35 days) in thesame types of patients,13,15 a finding that revolutionized thecare of patients with acute myocardial infarction. However,these trials were performed at selected hospital sites, involvedfew patients, and except in one case, used thrombolytic regimensthat are suboptimal by today's standards.
Another difference in outcome between this and other trials4,5may relate to the technical results of the angioplasty itself.Technical success, with restoration of TIMI grade 3 flow, wasreported in 92 to 97 percent of patients in previous trials,5,24albeit without independent confirmation by a core angiographiclaboratory. Technical success, as determined by the core laboratory,was obtained in 93 percent of the patients in GUSTO IIb, withTIMI grade 3 flow restored in 73 percent. These differencesmay be due to the more globally representative outcome in GUSTOIIb or to the fact that even at established core angiographiclaboratories, determinations of TIMI flow are frequently discrepant.25Recent reported rates for the success of primary angioplastyin the community range from 46 to 93 percent.26,27
Although there was no significant relation between the operator'sexperience with angioplasty and the effect of treatment, 85percent of angioplasties in this study were performed by operatorswho performed more than 75 such procedures per year. In thelight of some reports of a relation between higher volume ofangioplasty and better outcome for patients,28 the results ofthis study should not be extrapolated to operators with lowerangioplasty volumes.
The results of this study also differ from those of certainprevious trials in that the patients in the higher-risk groupsdid not appear to gain greater benefit from angioplasty. Inthe first Primary Angioplasty Myocardial Infarction Study (PAMI-I),5the patients found in a post hoc analysis to be at high risk(those older than 70, with anterior infarctions, or with heartrates greater than 100 beats per minute at admission) had afar lower in-hospital mortality with angioplasty (2.0 percent)than patients receiving thrombolytic therapy (10.4 percent),and others did not appear to benefit. No significant differentialeffect was observed in this study. It should be acknowledgedthat patients at highest risk, those in Killip class 3 or 4,are represented in very small numbers in this and other trials.4,5Subgroup analyses from small trials in particular should be interpreted with caution, and it will require furtherstudy to resolve this issue. The small but definite excess ofhemorrhagic strokes with t-PA in this study is consistent withthe findings of the PAMI-I trial,5 but the risk associated witht-PA appears to be considerably greater than what might be expectedon the basis of the findings of far larger studies6 (e.g., 1.4percent in this substudy, as compared with 0.5 percent in themain study20). This finding may be a reason to suggest thatangioplasty would be preferable in patients at highest riskfor intracranial hemorrhage.29
A further and perhaps unexpected finding was the timing of thebenefit of angioplasty (Figure 1A and Figure 1B). If the mechanismof this benefit is the early restoration of TIMI grade 3 flow,the importance of which was demonstrated in the GUSTO-I trial,then a benefit should have been evident within 24 hours.23 Thedelayed benefit, particularly with respect to reinfarction,suggests that either spontaneous or procedure-related reinfarctionbetween day 5 and day 10 in the t-PA group accounted for muchof the difference in outcome, as Stone and colleagues also suggested.30
The attenuation of the benefit of angioplasty at six monthsis notable. Smaller trials have reported mixed results afterdischarge from the hospital.31,32,33 This finding may have beena consequence of the relatively high rate of coronary reocclusionafter angioplasty, which has been noted in serial angiographicstudies.34
Given the striking reduction in adverse outcomes in patientstreated with inhibitors of the platelet glycoprotein IIb/IIIareceptor as an adjunct to angioplasty35,36 and the possiblebenefit of these agents combined with thrombolytic therapy,37the possible improvement in outcome early after infarction withprimary stenting as compared with angioplasty alone,38,39,40,41and the reduction in intermediate-term revascularization inselected patients treated with stents,42,43 this study shouldbe regarded as only a step in the continued development of optimalreperfusion strategies. The speed, completeness, and durabilityof reperfusion, and thus outcomes for patients, will probablyimprove with both angioplasty and thrombolytic therapy.
At present, physicians deciding which therapy to offer a patientwho is eligible for either treatment should return to fundamentalsestablished in multiple large studies. The rapid restorationof brisk antegrade coronary flow is critical in reducing mortality.1,2The time from presentation to angioplasty in GUSTO IIb (1.9hours) was greater than the time from randomization in the PAMIand Dutch trials (1.0 hour in each)4,5 and nearly the same asin the more broadly representative Second National Registryof Myocardial Infarction (2.0 hours).17 If a skilled cardiologistis readily available and the patient can be treated rapidly,angioplasty may be preferable. Patients with severe hypertension,advanced age, or symptomatic cerebrovascular disease shouldalso be treated with angioplasty, if available, to lower therisk of intracranial hemorrhage.29 In most situations, however,thrombolytic therapy should still be regarded as an excellentstrategy of reperfusion. The important point is not to delayin restoring myocardial reperfusion in suitable candidates withtwo attractive alternatives.
Supported in part by Guidant Corporation, Redwood City, Calif.,and by CibaGeigy, Summit, N.J.
* The investigators and centers participating in the GUSTO IIbAngioplasty Substudy are listed in the Appendix.
Source Information
Dr. Ellis assumes responsibility for the content of the article.
Address reprint requests to Dr. Stephen G. Ellis at the Cleveland Clinic Foundation, 9500 Euclid Ave., F-25, Cleveland, OH 44195.
References
Vogt A, von Essen R, Tebbe U, Feuerer W, Appel KF, Neuhaus KL. Impact of early perfusion status of the infarct-related artery on short-term mortality after thrombolysis for acute myocardial infarction: retrospective analysis of four German multicenter studies. J Am Coll Cardiol 1993;21:1391-1395. [Abstract]
The GUSTO Angiographic Investigators. The effects of tissue plasminogen activator, streptokinase, or both on coronary-artery patency, ventricular function, and survival after acute myocardial infarction. N Engl J Med 1993;329:1615-1622. [Erratum, N Engl J Med 1994;330:516.] [Free Full Text]
Simes RJ, Topol EJ, Holmes DR Jr, et al. Link between the angiographic substudy and mortality outcomes in a large randomized trial of myocardial reperfusion: importance of early and complete infarct artery reperfusion. Circulation 1995;91:1923-1928. [Free Full Text]
Zijlstra F, de Boer MJ, Hoorntje JCA, Reiffers S, Reiber JHC, Suryapranata H. A comparison of immediate coronary angioplasty with intravenous streptokinase in acute myocardial infarction. N Engl J Med 1993;328:680-684. [Free Full Text]
Grines CL, Browne KF, Marco J, et al. A comparison of immediate angioplasty with thrombolytic therapy for acute myocardial infarction.N Engl J Med 1993;328:673-9.
The GUSTO Investigators. An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. N EnglJ Med 1993;329:673-82.
Gibbons RJ, Holmes DR, Reeder GS, Bailey KR, Hopfenspirger MR, Gersh BJ. Immediate angioplasty compared with the administration of a thrombolytic agent followed by conservative treatment for myocardial infarction. N Engl J Med 1993;328:685-691. [Free Full Text]
DeWood MA. Direct PTCA vs intravenous t-PA in acute myocardial infarction: results from a prospective randomized trial. In: Abstracts of the Sixth Thrombolysis and Interventional Therapy in Acute Myocardial Infarction Symposium, November 11, 1990. Washington, D.C.: Mason Medical, 1990:28-9. abstract.
Ribeiro EE, Silva LA, Carneiro R, et al. Randomized trial of direct coronary angioplasty versus intravenous streptokinase in acute myocardial infarction. J Am Coll Cardiol 1993;22:376-380. [Abstract]
Elízaga J, García EJ, Bueno H, et al. Primary coronary angioplasty versus systemic thrombolysis in acute anterior myocardial infarction: in-hospital results from a prospective randomized trial. Eur Heart J 1993;14:Suppl:118-118.abstract
Ribichini F, Steffenino G, Dellavalle A, et al. Primary angioplasty versus thrombolysis in inferior acute myocardial infarction with anterior ST-segment depression, a single-center randomized study. J Am Coll Cardiol 1996;27:Suppl A:221A-221A.abstract
Grinfeld L, Berrocal D, Belardi J, et al. Fibrinolytics vs primary angioplasty in acute myocardial infarction (FAP): a randomized trial in a community hospital in Argentina. J Am Coll Cardiol 1996;27:Suppl A:222A-222A.abstract
Gruppo Italiano per lo Studio della Streptochinasi nell'Infarto Miocardico (GISSI). Long-term effects of intravenous thrombolysis in acute myocardial infarction: final report of the GISSI study. Lancet 1987;2:871-874. [Medline]
Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico. GISSI-2: a factorial randomised trial of alteplase versus streptokinase and heparin versus no heparin among 12 490 patients with acute myocardial infarction. Lancet 1990;336:65-71. [Medline]
ISIS-2 (Second International Study of Infarct Survival) Collaborative Group. Randomised trial of intravenous streptokinase, oral aspirin, both, or neither among 17 187 cases of suspected acute myocardial infarction: ISIS-2. Lancet 1988;2:349-360. [Medline]
Every NR, Parsons LS, Hlatky M, Martin JS, Weaver WD. A comparison of thrombolytic therapy with primary coronary angioplasty for acute myocardial infarction. N Engl J Med 1996;335:1253-1260. [Free Full Text]
Cannon CP, Lambrew CT, Tiefenbrunn AJ, et al. Influence of door-to-balloon time on mortality in primary angioplasty results in 3,648 patients in the Second National Registry of Myocardial Infarction (NRMI-2). J Am Coll Cardiol 1996;27:Suppl A:61A-61A.abstract
Lefkovits J, Topol EJ. Direct thrombin inhibitors in cardiovascular medicine. Circulation 1994;90:1522-1536. [Free Full Text]
Antman EM. Hirudin in acute myocardial infarction: safety report from the Thrombolysis and Thrombin Inhibition in Myocardial Infarction (TIMI 9A) Trial. Circulation 1994;90:1624-1630. [Free Full Text]
The Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) IIb Investigators. A comparison of recombinant hirudin with heparin for the treatment of acute coronary syndromes. N Engl J Med 1996;335:775-782. [Free Full Text]
Mancini GB, Simon SB, McGillem MJ, LeFree MT, Friedman HZ, Vogel RA. Automated quantitative coronary arteriography: morphologic and physiologic validation in vivo of a rapid digital angiographic method. Circulation 1987;75:452-460. [Erratum, Circulation 1987;75:1199.] [Free Full Text]
O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics 1979;35:549-556. [CrossRef][Medline]
Lan KKG, DeMets DL. Discrete sequential boundaries for clinical trials. Biometrika 1983;70:659-663. [Free Full Text]
de Boer MJ, Suryapranata H, Hoorntje JC, et al. Limitation of infarct size and preservation of left ventricular function after primary coronary angioplasty compared with intravenous streptokinase in acute myocardial infarction. Circulation 1994;90:753-761. [Free Full Text]
Ross AM, Neuhaus K-L, Ellis SG. Frequent lack of concordance among core laboratories in assessing TIMI flow grade after reperfusion therapy. Circulation 1995;92:Suppl I:I-718.abstract
Jhangiani AH, Jorgensen MB, Mansukhani PW, Aharonian VJ, Mahrer PR. Community practice of primary angioplasty for myocardial infarction. J Am Coll Cardiol 1996;27:Suppl A:61A-61A.abstract
Neuhaus K-L, Vogt A, Harmjanz D, et al. Primary PTCA in acute myocardial infarction: results from a German multicenter registry. J Am Coll Cardiol 1996;27:Suppl A:62A-62A.abstract
Ritchie JL, Phillips KA, Luft HS. Coronary angioplasty: statewide experience in California. Circulation 1993;88:2735-2743. [Free Full Text]
Gore JM, Granger CB, Simoons ML, et al. Stroke after thrombolysis: mortality and functional outcomes in the GUSTO-I trial. Circulation 1995;92:2811-2818. [Free Full Text]
Stone GW, Grines CL, Browne KF, et al. Primary angioplasty reduces recurrent ischemic events compared to tPA in myocardial infarction: implications for early discharge. Circulation 1993;88:Suppl:I-105.abstract
Stone GW, Grines CL, Browne KF, et al. Predictors of in-hospital and 6-month outcome after acute myocardial infarction in the reperfusion era: the Primary Angioplasty in Myocardial Infarction (PAMI) Trial. J Am Coll Cardiol 1995;25:370-377. [Abstract]
Veen G, de Boer MJ, Zijlstra F, Verheugt FWA. Better vessel status with less reocclusion at 3 months as additional mechanism for improved outcome for primary angioplasty for acute myocardial infarction. J Am Coll Cardiol 1995;:295A-295A.abstract
Michels KB, Yusuf S. Does PTCA in acute myocardial infarction affect mortality and reinfarction rates? A quantitative overview (meta-analysis) of the randomized clinical trials. Circulation 1995;91:476-485. [Free Full Text]
Nakagawa Y, Iwasaki Y, Kimura T, et al. Serial angiographic follow-up after successful direct angioplasty for acute myocardial infarction. Am J Cardiol 1996;78:980-984. [CrossRef][Medline]
The EPIC Investigators. Use of a monoclonal antibody directed against the platelet glycoprotein IIb/IIIa receptor in high-risk coronary angioplasty. N Engl J Med 1994;330:956-961. [Free Full Text]
Lincoff AM, Tcheng JE, Miller DP, Booth JE, Montague EA, Topol EJ. Marked enhancement of clinical efficacy of platelet GP IIb/IIIa blockade with c7E3 Fab (abciximab) linked to reduction in bleeding complications: outcome in the EPILOG and EPIC trials. Circulation 1996;94:Suppl I:I-375.abstract
Ohman EM, Kleiman NS, Gacioch G, et al. Combined accelerated tissue-plasminogen activator and platelet glycoprotein IIb/IIIa integrin receptor blockade with Integrilin in acute myocardial infarction: results of a randomized, placebo-controlled, dose-ranging trial. Circulation 1997;95:846-854. [Free Full Text]
Hoorntje JC, Suryapranata H, de Boer M-J, Zijlstra F, van 't Hof AW, van den Brink L. ESCOBAR: primary stenting for acute myocardial infarction: preliminary results of a randomized trial. Circulation 1996;94:Suppl I:I-570.abstract
Saito S, Hosokawa G, Miyake S, Yamamoto S. Successful reperfusion with transradial angioplasty safely result in early ambulation and shorten hospital stay in a selected subgroup of acute myocardial infarction -- the results of the Kamakura PASTA Trial. J Am Coll Cardiol 1997;29:Suppl A:235A-235A.abstract [CrossRef]
Rodriguez A, Fernandez M, Bernardi V, et al. Coronary stents improved hospital results during coronary angioplasty in acute myocardial infarction: preliminary results of a randomized controlled study (GRAMI Trial). J Am Coll Cardiol 1997;29:Suppl A:221A-221A.abstract
Antoniucci D, Santoro GM, Bolognese L, et al. Elective stenting in acute myocardial infarction: preliminary results of the Florence Randomized Elective Stenting in Acute Coronary Occlusion (FRESCO) Study. J Am Coll Cardiol 1997;29:Suppl A:456A-456A.abstract
Fischman DL, Leon MB, Baim DS, et al. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. N Engl J Med 1994;331:496-501. [Free Full Text]
Serruys PW, de Jaegere P, Kiemeneij F, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. N Engl J Med 1994;331:489-495. [Free Full Text]
Appendix
The following centers and investigators collaborated in thisstudy (values in parentheses denote the number of patients enrolled).Principal Investigators: A. Betriu, H. Phillips, and S. Ellis.Steering Committee: E. Topol (Study Chairman), R. Califf (ClinicalDirector, Coordinating Center), F. Van der Werf (Director, IntermediateCoordinating Center), A. Betriu (International Clinical Coordinator),D. Ardissino, P.W. Armstrong, P. Aylward, E. Bates, K. Beatt,J. Cheseboro, J. Col, S. Ellis, H. Emanuelsson, V. Fuster, W.B.Gibler, J. Gore, A. Guerci, J. Hochman, D. Holmes, N. Kleiman,D. Morris, K. Neuhaus, M. Ohman, M. Pfisterer, H. Phillips,W. Rutsch, J. Simes, M. Simoons, A. Vahanian, W.D. Weaver, andH. White. Coordinating Center: Duke University Medical Center,Durham, N.C. Clinician Coordinators: C. Granger, H.Phillips, J. Hochrein, and R. Califf; Coordinators: B. Fraulo,I. Moffie, and L. Paraschos; Statisticians: A. Stebbins, L.Woodlief, K. Lee, and K. Pieper; Electrocardiographic Core Laboratory:G.S. Wagner (Director) and K. Gates. Angiographic Core Laboratory:Cleveland Clinic Foundation, Cleveland S. Ellis (Director),D. Debowey, R. Poliszczuk, and H. Vilsack. International: ClinicalCoordinator: A. Betriu, Spain; Coordinators: A. Luyten, Belgium;L. Tobback, Belgium; M. Kava, Australia; and W. Sutherland,Canada. Data Safety and Monitoring Committee: R. Frye (Chairman),M. Cheitlin, D. DeMets, L. Fisher, J. Hirsh, P. Serruys, andL. Walters.
United States (401 patients): North Memorial Hospital, Robbinsdale:G. Hanovich and A. Antolick; Maine Medical Center,Portland:M. Kellett and C. Berg; Wilson Memorial Hospital, Johnson City:N.M. Jamal and D. Whiting; Mercy Hospital of Pittsburgh, Pittsburgh:V. Krishnaswami and A. Heyl; Lahey Clinic Medical Center, Burlington:D. Gossman and M. Dorland; Duke University Medical Center, Durham:H. Phillips and E. Berrios; Presbyterian Hospital, Albuquerque:H. White and R. Sexson; Lancaster General Hospital, Lancaster:J. Ibarra and L. Frey; St. Mary's Hospital, Tucson: L. Lancasterand D. Lansman; Louisiana State University Medical Center, Shreveport:F. Sheridan and R. McRae; Cleveland Clinic Foundation, Cleveland:S. Ellis and S. Hejl; Robert W. Johnson Hospital, New Brunswick:S. Palmeri and L. Casazza; York Hospital, York: W. Schradingand N. Sonin; McLellan Memorial Veterans Affairs Hospital, LittleRock: D. Talley; University of Arkansas, Little Rock: J. Talleyand S. Ashcraft; DartmouthHitchcock Medical Center, Lebanon:N. Niles and R. Edkins; St. Joseph's Hospital, Lancaster: J.Ibarra and L. Hollywood; Cottonwood Hospital, Murray: G. Symkoviakand J. Pincock; West Florida Hospital, Pensacola: D. Mishkeland J. Lehmann; Crawford Long Hospital, Atlanta: D. Morris andR. Law-McKenzie; St. Joseph's Hospital, Savannah: P.C. Gaineyand D. Baker; FairviewSouthdale Hospital, Edina: W. Maddoxand C. Sturm; Santa Rosa Memorial Hospital, Santa Rosa: R. Millerand S. Woods; Audubon Regional Medical Center, Louisville: D.Dageford and J. Hanrahan; Hershey Medical Center, Hershey: I.Gilchrist and H. Zimmerman; E. Alabama Medical Center, Opelika:M. Williams and G. Stegall; St. Mark's Hospital, Salt Lake City:J. Perry and W. Schvaneveldt; Oakwood Hospital, Dearborn: A.Riba and C. Draus; Shadyside Hospital, Pittsburgh: J.D. O'Tooleand K. Sudina; Morton Plant Hospital, Largo: D. Spriggs andF. Schulz; Memorial Mission Hospital, Asheville: W.T. Maddoxand S. Allan; Good Samaritan Hospital, Dayton: D. Hammer andC. White; University Community Hospital, Tampa: J. Smith andL. Harrah; Proctor Hospital, Peoria: P. Schmidt and C. Ness;St. Joseph's Medical Center, Albuquerque: J. Kaplan and G. Steffans;Rochester General Hospital, Rochester: G. Gacioch and V. Chiodo;and Roper Hospital, Charleston: K. Hanger and C. Chapuseaux.Spain (239 patients): Hospital Gregorio Marañon, Madrid:E. Garcia Fernandez; Hospital Clinico y Provincial, Barcelona:A. Betriu; and Hospital Clinico Universitario, Valladolid: F.Fernadez Aviles. Belgium (166 patients): Hôpital de laCitadelle, Liège: J. Boland; Cliniques Saint-Luc, Brussels:J. Col; Clinique Saint-Jean, Brussels: M. Castadot; Centre HospitalierUniversitaire Sart Tilman, Liège: V. Legrand; and CliniquesUniversitaires de Mont-Godinne, Yvoir: E. Schroeder. Italy (121patients): Ospedale Borgo Trento, Verona: C. Vassanelli; OspedaleMaggiore, Novara: C. Cernigliaro; Ospedale de Circolo, Varese:S. Repetto; and Ospedali Riuniti, Bergamo: O. Valsecchi. Germany(64 patients): Krankenhaus am Urban, BerlinKreuzberg:H. Topp; and Freie Universität Berlin, Berlin: W. Rutsch.Sweden (62 patients): Sahlgrenska Hospital, Göteborg: H.Emanuelsson; and Mölndal Hospital, Mölndal: M. Risenfors.Switzerland (46 patients): Kantonspital, Basel: M. Pfisterer;Universitatsspital, Zurich: F.W. Amann; and Hôpital Cantonal,Geneva: P. Urban. Australia (37 patients): Flinders MedicalCentre, Adelaide: P. Aylward and S. Dolan; Royal North ShoreHospital, St. Leonards: G. Nelson and R. Scammell; and PrinceCharles Hospital, Chermside: N. Bett and C. Newitt. Canada (2patients): University of Ottawa, Ottawa: M. Labinza and S. Kearns.
Bonnefoy, E., Steg, P. G., Boutitie, F., Dubien, P.-Y., Lapostolle, F., Roncalli, J., Dissait, F., Vanzetto, G., Leizorowicz, A., Kirkorian, G., for the CAPTIM Investigators,
(2009). Comparison of primary angioplasty and pre-hospital fibrinolysis in acute myocardial infarction (CAPTIM) trial: a 5-year follow-up. Eur Heart J
30: 1598-1606
[Abstract][Full Text]
Donnan, G. A., Davis, S. M.
(2009). IV and IA Thrombolytic Stroke Strategies Are Complementary. Stroke
40: 2615-2615
[Full Text]
Huynh, T., Perron, S., O'Loughlin, J., Joseph, L., Labrecque, M., Tu, J. V., Theroux, P.
(2009). Comparison of Primary Percutaneous Coronary Intervention and Fibrinolytic Therapy in ST-Segment-Elevation Myocardial Infarction: Bayesian Hierarchical Meta-Analyses of Randomized Controlled Trials and Observational Studies. Circulation
119: 3101-3109
[Abstract][Full Text]
Bogaty, P.
(2009). Duration of Symptoms Is Not Always the Key Modulator of the Choice of Reperfusion for ST-Elevation Myocardial Infarction. Circulation
119: 1304-1310
[Full Text]
Terkelsen, C J, Christiansen, E H, Sorensen, J T, Kristensen, S D, Lassen, J F, Thuesen, L, Andersen, H R, Vach, W, Nielsen, T T
(2009). Primary PCI as the preferred reperfusion therapy in STEMI: it is a matter of time. Heart
95: 362-369
[Abstract][Full Text]
Glaser, R., Naidu, S. S., Selzer, F., Jacobs, A. K., Laskey, W. K., Srinivas, V. S., Slater, J. N., Wilensky, R. L.
(2008). Factors Associated With Poorer Prognosis for Patients Undergoing Primary Percutaneous Coronary Intervention During Off-Hours: Biology or Systems Failure?. J Am Coll Cardiol Intv
1: 681-688
[Abstract][Full Text]
Bates, E. R., Nallamothu, B. K.
(2008). Commentary: The Role of Percutaneous Coronary Intervention in ST-Segment-Elevation Myocardial Infarction. Circulation
118: 567-573
[Full Text]
Lindholm, M. G., Boesgaard, S., Thune, J. J., Kelbaek, H., Andersen, H. R., Kober, L., DANAMI-2 investigators,
(2008). Percutaneous coronary intervention for acute MI does not prevent in-hospital development of cardiogenic shock compared to fibrinolysis. Eur J Heart Fail
10: 668-674
[Abstract][Full Text]
Ellis, S. G., Tendera, M., de Belder, M. A., van Boven, A. J., Widimsky, P., Janssens, L., Andersen, H.R., Betriu, A., Savonitto, S., Adamus, J., Peruga, J. Z., Kosmider, M., Katz, O., Neunteufl, T., Jorgova, J., Dorobantu, M., Grinfeld, L., Armstrong, P., Brodie, B. R., Herrmann, H. C., Montalescot, G., Neumann, F.-J., Effron, M. B., Barnathan, E. S., Topol, E. J., the FINESSE Investigators,
(2008). Facilitated PCI in Patients with ST-Elevation Myocardial Infarction. NEJM
358: 2205-2217
[Abstract][Full Text]
Busk, M., Maeng, M., Rasmussen, K., Kelbaek, H., Thayssen, P., Abildgaard, U., Vigholt, E., Mortensen, L. S., Thuesen, L., Kristensen, S. D., Nielsen, T. T., Andersen, H. R., for the DANAMI-2 Investigators,
(2008). The Danish multicentre randomized study of fibrinolytic therapy vs. primary angioplasty in acute myocardial infarction (the DANAMI-2 trial): outcome after 3 years follow-up. Eur Heart J
29: 1259-1266
[Abstract][Full Text]
Ratcliffe, A T, Pepper, C
(2008). Thrombolysis or primary angioplasty? Reperfusion therapy for myocardial infarction in the UK. Postgrad. Med. J.
84: 73-77
[Abstract][Full Text]
Khan, S Q, Quinn, P, Davies, J E, Ng, L L
(2008). N-terminal pro-B-type natriuretic peptide is better than TIMI risk score at predicting death after acute myocardial infarction. Heart
94: 40-43
[Abstract][Full Text]
Dobrzycki, S., Kralisz, P., Nowak, K., Prokopczuk, P., Kochman, W., Korecki, J., Poniatowski, B., Zuk, J., Sitniewska, E., Bachorzewska-Gajewska, H., Sienkiewicz, J., Musial, W. J
(2007). Transfer with GP IIb/IIIa inhibitor tirofiban for primary percutaneous coronary intervention vs. on-site thrombolysis in patients with ST-elevation myocardial infarction (STEMI): a randomized open-label study for patients admitted to community hospitals. Eur Heart J
28: 2438-2448
[Abstract][Full Text]
Brophy, J. M
(2007). Has thrombolysis lost its mojo?. Heart
93: 1167-1169
[Full Text]
Asseburg, C., Bravo Vergel, Y., Palmer, S., Fenwick, E., de Belder, M., Abrams, K. R, Sculpher, M.
(2007). Assessing the effectiveness of primary angioplasty compared with thrombolysis and its relationship to time delay: a Bayesian evidence synthesis. Heart
93: 1244-1250
[Abstract][Full Text]
Boden, W. E., Eagle, K., Granger, C. B.
(2007). Reperfusion Strategies in Acute ST-Segment Elevation Myocardial Infarction: A Comprehensive Review of Contemporary Management Options. J Am Coll Cardiol
50: 917-929
[Abstract][Full Text]
Lin, G. A., Dudley, R. A., Redberg, R. F.
(2007). Cardiologists' Use of Percutaneous Coronary Interventions for Stable Coronary Artery Disease. Arch Intern Med
167: 1604-1609
[Abstract][Full Text]
Timmer, J. R., Ottervanger, J. P., de Boer, M.-J., Boersma, E., Grines, C. L., Westerhout, C. M., Simes, R. J., Granger, C. B., Zijlstra, F., for the Primary Coronary Angioplasty vs Thrombolys,
(2007). Primary Percutaneous Coronary Intervention Compared With Fibrinolysis for Myocardial Infarction in Diabetes Mellitus: Results From the Primary Coronary Angioplasty vs Thrombolysis-2 Trial. Arch Intern Med
167: 1353-1359
[Abstract][Full Text]
King, S. B. III, Aversano, T., Ballard, W. L., Beekman, R. H. III, Cowley, M. J., Ellis, S. G., Faxon, D. P., Hannan, E. L., Hirshfeld, J. W. Jr, Jacobs, A. K., Kellett, M. A. Jr, Kimmel, S. E., Landzberg, J. S., McKeever, L. S., Moscucci, M., Pomerantz, R. M., Smith, K. M., Vetrovec, G. W., Creager, M. A., Hirshfeld, J. W. Jr, Holmes, D. R. Jr, Newby, L. K., Weitz, H. H., Merli, G., Pina, I., Rodgers, G. P., Tracy, C. M.
(2007). ACCF/AHA/SCAI 2007 Update of the Clinical Competence Statement on Cardiac Interventional Procedures: A Report of the American College of Cardiology Foundation/American Heart Association/American College of Physicians Task Force on Clinical Competence and Training (Writing Committee to Update the 1998 Clinical Competence Statement on Recommendations for the Assessment and Maintenance of Proficiency in Coronary Interventional Procedures). J Am Coll Cardiol
50: 82-108
[Full Text]
Alexander, K. P., Newby, L. K., Cannon, C. P., Armstrong, P. W., Gibler, W. B., Rich, M. W., Van de Werf, F., White, H. D., Weaver, W. D., Naylor, M. D., Gore, J. M., Krumholz, H. M., Ohman, E. M.
(2007). Acute Coronary Care in the Elderly, Part I: Non-ST-Segment-Elevation Acute Coronary Syndromes: A Scientific Statement for Healthcare Professionals From the American Heart Association Council on Clinical Cardiology: In Collaboration With the Society of Geriatric Cardiology. Circulation
115: 2549-2569
[Abstract][Full Text]
Alexander, K. P., Newby, L. K., Armstrong, P. W., Cannon, C. P., Gibler, W. B., Rich, M. W., Van de Werf, F., White, H. D., Weaver, W. D., Naylor, M. D., Gore, J. M., Krumholz, H. M., Ohman, E. M.
(2007). Acute Coronary Care in the Elderly, Part II: ST-Segment-Elevation Myocardial Infarction: A Scientific Statement for Healthcare Professionals From the American Heart Association Council on Clinical Cardiology: In Collaboration With the Society of Geriatric Cardiology. Circulation
115: 2570-2589
[Abstract][Full Text]
Hollenbeak, C. S., Fitzgibbons, J. P., Rossi, M., Morris, D. L., Stillman, P.
(2007). The Impact of Percutaneous Coronary Interventions on Outcomes for Acute Myocardial Infarction in Pennsylvania. American Journal of Medical Quality
22: 85-94
[Abstract]
Ting, H. H., Yang, E. H., Rihal, C. S.
(2006). Narrative review: reperfusion strategies for ST-segment elevation myocardial infarction.. ANN INTERN MED
145: 610-617
[Abstract][Full Text]
Stenestrand, U., Lindback, J., Wallentin, L., for the RIKS-HIA Registry,
(2006). Long-term outcome of primary percutaneous coronary intervention vs prehospital and in-hospital thrombolysis for patients with ST-elevation myocardial infarction.. JAMA
296: 1749-1756
[Abstract][Full Text]
Laarman, G. J., Suttorp, M. J., Dirksen, M. T., van Heerebeek, L., Kiemeneij, F., Slagboom, T., van der Wieken, L. R., Tijssen, J. G.P., Rensing, B. J., Patterson, M.
(2006). Paclitaxel-Eluting versus Uncoated Stents in Primary Percutaneous Coronary Intervention. NEJM
355: 1105-1113
[Abstract][Full Text]
Idanpaan-Heikkila, U. M., Lambie, L., Mattke, S., McLaughlin, V., Palmer, H., Tu, J. V.
(2006). Selecting indicators for the quality of cardiac care at the health system level in Organization for Economic Co-operation and Development countries. Int J Qual Health Care
18: 39-44
[Abstract][Full Text]
Boersma, E., The Primary Coronary Angioplasty vs. Thrombolysis,
(2006). Does time matter? A pooled analysis of randomized clinical trials comparing primary percutaneous coronary intervention and in-hospital fibrinolysis in acute myocardial infarction patients. Eur Heart J
27: 779-788
[Abstract][Full Text]
(2005). Part 8: Stabilization of the Patient With Acute Coronary Syndromes. Circulation
112: IV-89-IV-110
[Full Text]
Dawkins, K D, Gershlick, T, de Belder, M, Chauhan, A, Venn, G, Schofield, P, Smith, D, Watkins, J, Gray, H H, Joint Working Group on Percutaneous Coronary Inter,
(2005). Percutaneous coronary intervention: recommendations for good practice and training. Heart
91: vi1-vi27
[Abstract][Full Text]
Bilge, A. K., Nisanci, Y., Yilmaz, E., Ozben, B., Oncul, A., Mercanoglu, F., Meric, M.
(2005). Effects of Percutaneous Coronary Thrombectomywith the X-Sizer Catheter on Epicardial Flow and Microvascular Function in Acute Coronary Syndromes. CLIN APPL THROMB HEMOST
11: 461-466
[Abstract]
Zeymer, U., Zahn, R., Schiele, R., Jansen, W., Girth, E., Gitt, A., Seidl, K., Schroder, R., Schneider, S., Senges, J.
(2005). Early eptifibatide improves TIMI 3 patency before primary percutaneous coronary intervention for acute ST elevation myocardial infarction: results of the randomized integrilin in acute myocardial infarction (INTAMI) pilot trial. Eur Heart J
26: 1971-1977
[Abstract][Full Text]
Huber, K., Caterina, R. D., Kristensen, S. D., Verheugt, F. W.A., Montalescot, G., Maestro, L. B., Werf, F. V. d., for the Task Force on Pre-hospital Reperfusion The,
(2005). Pre-hospital reperfusion therapy: a strategy to improve therapeutic outcome in patients with ST-elevation myocardial infarction. Eur Heart J
26: 2063-2074
[Full Text]
De Luca, G., Suryapranata, H., Grimaldi, R., Chiariello, M.
(2005). Coronary stenting and abciximab in primary angioplasty for ST-segment-elevation myocardial infarction. QJM
98: 633-641
[Abstract][Full Text]
Le May, M. R., Wells, G. A., Labinaz, M., Davies, R. F., Turek, M., Leddy, D., Maloney, J., McKibbin, T., Quinn, B., Beanlands, R. S., Glover, C., Marquis, J.-F., O'Brien, E. R., Williams, W. L., Higginson, L. A.
(2005). Combined Angioplasty and Pharmacological Intervention Versus Thrombolysis Alone in Acute Myocardial Infarction (CAPITAL AMI Study). J Am Coll Cardiol
46: 417-424
[Abstract][Full Text]
Authors/Task Force Members, , Silber, S., Albertsson, P., Aviles, F. F., Camici, P. G., Colombo, A., Hamm, C., Jorgensen, E., Marco, J., Nordrehaug, J.-E., Ruzyllo, W., Urban, P., Stone, G. W., Wijns, W.
(2005). Guidelines for Percutaneous Coronary Interventions: The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Eur Heart J
26: 804-847
[Full Text]
Mehta, R. H., Granger, C. B., Alexander, K. P., Bossone, E., White, H. D., Sketch, M. H. Jr
(2005). Reperfusion strategies for acute myocardial infarction in the elderly: Benefits and risks. J Am Coll Cardiol
45: 471-478
[Abstract][Full Text]
Machecourt, J., Bonnefoy, E., Vanzetto, G., Motreff, P., Marliere, S., Leizorovicz, A., Allenet, B., Lacroute, J. M., Cassagnes, J., Touboul, P.
(2005). Primary angioplasty is cost-minimizing compared with pre-hospital thrombolysis for patients within 60 min of a percutaneous coronary intervention center: The Comparison of Angioplasty and Pre-hospital Thrombolysis in Acute Myocardial Infarction (CAPTIM) cost-efficacy sub-study. J Am Coll Cardiol
45: 515-524
[Abstract][Full Text]
Nallamothu, B. K., Bates, E. R., Herrin, J., Wang, Y., Bradley, E. H., Krumholz, H. M., for the NRMI Investigators,
(2005). Times to Treatment in Transfer Patients Undergoing Primary Percutaneous Coronary Intervention in the United States: National Registry of Myocardial Infarction (NRMI)-3/4 Analysis. Circulation
111: 761-767
[Abstract][Full Text]
Hobbs, M S T, McCaul, K A, Knuiman, M W, Rankin, J M, Gilfillan, I
(2004). Trends in coronary artery revascularisation procedures in Western Australia, 1980-2001. Heart
90: 1036-1041
[Abstract][Full Text]
Brophy, J. M., Bogaty, P.
(2004). Primary Angioplasty and Thrombolysis Are Both Reasonable Options in Acute Myocardial Infarction. ANN INTERN MED
141: 292-297
[Abstract][Full Text]
Writing Committee Members, , Antman, E. M., Anbe, D. T., Armstrong, P. W., Bates, E. R., Green, L. A., Hand, M., Hochman, J. S., Krumholz, H. M., Kushner, F. G., Lamas, G. A., Mullany, C. J., Ornato, J. P., Pearle, D. L., Sloan, M. A., Smith, S. C. Jr, Task Force Members, , Antman, E. M., Smith, S. C. Jr, Alpert, J. S., Anderson, J. L., Faxon, D. P., Fuster, V., Gibbons, R. J., Gregoratos, G., Halperin, J. L., Hiratzka, L. F., Hunt, S. A., Jacobs, A. K., Ornato, J. P.
(2004). ACC/AHA guidelines for the management of patients with ST-Elevation myocardial infarction--executive summary: A report of the American College of Cardiology/American Heart Association Task Force on practice guidelines (writing committee to revise the 1999 guidelines for the management of patients with acute myocardial infarction) . J Am Coll Cardiol
44: 671-719
[Full Text]
Antman, E. M., Anbe, D. T., Armstrong, P. W., Bates, E. R., Green, L. A., Hand, M., Hochman, J. S., Krumholz, H. M., Kushner, F. G., Lamas, G. A., Mullany, C. J., Ornato, J. P., Pearle, D. L., Sloan, M. A., Smith, S. C. Jr, Antman, E. M., Smith, S. C. Jr, Alpert, J. S., Anderson, J. L., Faxon, D. P., Fuster, V., Gibbons, R. J., Gregoratos, G., Halperin, J. L., Hiratzka, L. F., Hunt, S. A., Jacobs, A. K., Ornato, J. P.
(2004). ACC/AHA Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction--Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1999 Guidelines for the Management of Patients With Acute Myocardial Infarction). Circulation
110: 588-636
[Full Text]
Khan, I. A.
(2004). Initial Therapy for Acute Myocardial Infarction in the Real World. Chest
126: 331-333
[Full Text]
Costantini, C. O., Stone, G. W., Mehran, R., Aymong, E., Grines, C. L., Cox, D. A., Stuckey, T., Turco, M., Gersh, B. J., Tcheng, J. E., Garcia, E., Griffin, J. J., Guagliumi, G., Leon, M. B., Lansky, A. J.
(2004). Frequency, correlates, and clinical implications of myocardial perfusion after primary angioplasty and stenting, with and without glycoprotein IIb/IIIa inhibition, in acute myocardial infarction. J Am Coll Cardiol
44: 305-312
[Abstract][Full Text]
Simon, D. I., Sakuma, M.
(2004). Platelet disaggregation: Putting time on your side in acute myocardial infarction. J Am Coll Cardiol
44: 324-326
[Full Text]
Montalescot, G, Andersen, H R, Antoniucci, D, Betriu, A, de Boer, M J, Grip, L, Neumann, F J, Rothman, M T
(2004). Recommendations on percutaneous coronary intervention for the reperfusion of acute ST elevation myocardial infarction. Heart
90: e37-e37
[Abstract][Full Text]
Singh, M., Ting, H. H., Gersh, B. J., Berger, P. B., Lennon, R. J., Holmes, D. R. Jr, Garratt, K. N.
(2004). Percutaneous Coronary Intervention for ST-Segment and Non-ST-Segment Elevation Myocardial Infarction at Hospitals With and Without On-site Cardiac Surgical Capability. Mayo Clin Proc.
79: 738-744
[Abstract]
Mehta, R. H., Harjai, K. J., Grines, L., Stone, G. W., Boura, J., Cox, D., O'Neill, W., Grines, C. L., Primary Angioplasty in Myocardial Infarction (PAMI,
(2004). Sustained ventricular tachycardia or fibrillation in the cardiac catheterization laboratory among patients receiving primary percutaneous coronary intervention: Incidence, predictors, and outcomes. J Am Coll Cardiol
43: 1765-1772
[Abstract][Full Text]
Taylor, A. J., Al-Saadi, N., Abdel-Aty, H., Schulz-Menger, J., Messroghli, D. R., Friedrich, M. G.
(2004). Detection of Acutely Impaired Microvascular Reperfusion After Infarct Angioplasty With Magnetic Resonance Imaging. Circulation
109: 2080-2085
[Abstract][Full Text]
Bax, M., de Winter, R. J., Schotborgh, C. E., Koch, K. T., Meuwissen, M., Voskuil, M., Adams, R., Mulder, K. J. J., Tijssen, J. G. P., Piek, J. J.
(2004). Short- and Long-Term recovery of left ventricular function predicted at the time of primary percutaneous coronary intervention in anterior myocardial infarction. J Am Coll Cardiol
43: 534-541
[Abstract][Full Text]
Keeley, E. C., Grines, C. L.
(2004). Primary Coronary Intervention for Acute Myocardial Infarction. JAMA
291: 736-739
[Full Text]
Le May, M. R., Davies, R. F., Labinaz, M., Sherrard, H., Marquis, J.-F., Laramee, L. A., O'Brien, E. R., Williams, W. L., Beanlands, R. S., Nichol, G., Higginson, L. A.
(2003). Hospitalization Costs of Primary Stenting Versus Thrombolysis in Acute Myocardial Infarction: Cost Analysis of the Canadian STAT Study. Circulation
108: 2624-2630
[Abstract][Full Text]
Mehta, R. H., Harjai, K. J., Cox, D., Stone, G. W., Brodie, B., Boura, J., O'Neill, W., Grines, C. L., Primary Angioplasty in Myocardial Infarction (PAMI,
(2003). Clinical and angiographic correlates and outcomes of suboptimal coronary flow inpatients with acute myocardial infarction undergoing primary percutaneous coronary intervention. J Am Coll Cardiol
42: 1739-1746
[Abstract][Full Text]
Kernis, S. J., Harjai, K. J., Stone, G. W., Grines, L. L., Boura, J. A., Yerkey, M. W., O'Neill, W., Grines, C. L.
(2003). The incidence, predictors, and outcomes of early reinfarction after primary angioplasty for acute myocardial infarction. J Am Coll Cardiol
42: 1173-1177
[Abstract][Full Text]
Andersen, H. R., Nielsen, T. T., Rasmussen, K., Thuesen, L., Kelbaek, H., Thayssen, P., Abildgaard, U., Pedersen, F., Madsen, J. K., Grande, P., Villadsen, A. B., Krusell, L. R., Haghfelt, T., Lomholt, P., Husted, S. E., Vigholt, E., Kjaergard, H. K., Mortensen, L. S., the DANAMI-2 Investigators,
(2003). A Comparison of Coronary Angioplasty with Fibrinolytic Therapy in Acute Myocardial Infarction. NEJM
349: 733-742
[Abstract][Full Text]
Dauerman, H. L., Sobel, B. E.
(2003). Synergistic treatment of ST-segmentelevation myocardial infarction with pharmacoinvasive recanalization. J Am Coll Cardiol
42: 646-651
[Abstract][Full Text]
Eisenberg, M. J., Jamal, S.
(2003). Glycoprotein IIb/IIIa inhibition in the setting of acute ST-segment elevation myocardial infarction. J Am Coll Cardiol
42: 1-6
[Abstract][Full Text]
Topaz, O., Perin, E. C., Jesse, R. L., Mohanty, P. K., Carr, M., Rosenschein, U.
(2003). Power Thrombectomy in Acute Ischemic Coronary Syndromes. ANGIOLOGY
54: 457-468
[Abstract]
Spencer, F. A., Becker, R. C.
(2003). Circadian variations in acute myocardial infarction: Patients or health care delivery?. J Am Coll Cardiol
41: 2143-2146
[Full Text]
McAlister, F. A., Straus, S. E., Sackett, D. L., Altman, D. G.
(2003). Analysis and Reporting of Factorial Trials: A Systematic Review. JAMA
289: 2545-2553
[Abstract][Full Text]
Wallentin, L., Bergstrand, L., Dellborg, M., Fellenius, C., Granger, C. B, Lindahl, B., Lins, L.-E., Nilsson, T., Pehrsson, K., Siegbahn, A., Swahn, E., for the ASSENT PLUS Investigators,
(2003). Low molecular weight heparin (dalteparin) compared to unfractionated heparin as an adjunct to rt-PA (alteplase) for improvement of coronary artery patency in acute myocardial infarction--the ASSENT Plus study. Eur Heart J
24: 897-908
[Abstract][Full Text]
Leong, J K, Ghabrial, R, McCluskey, P J, Mulligan, S
(2003). Orbital haemorrhage complication following postoperative thrombolysis. Br. J. Ophthalmol.
87: 655-656
[Full Text]
Lee, D. P., Herity, N. A., Hiatt, B. L., Fearon, W. F., Rezaee, M., Carter, A. J., Huston, M., Schreiber, D., DiBattiste, P. M., Yeung, A. C.
(2003). Adjunctive Platelet Glycoprotein IIb/IIIa Receptor Inhibition With Tirofiban Before Primary Angioplasty Improves Angiographic Outcomes: Results of the TIrofiban Given in the Emergency Room before Primary Angioplasty (TIGER-PA) Pilot Trial. Circulation
107: 1497-1501
[Abstract][Full Text]
The Task Force on the Management of Acute Myocardi, , Van de Werf, F., Ardissino, D., Betriu, A., Cokkinos, D. V., Falk, E., Fox, K. A.A., Julian, D., Lengyel, M., Neumann, F.-J., Ruzyllo, W., Thygesen, C., Underwood, S. R., Vahanian, A., Verheugt, F. W.A., Wijns, W.
(2003). Management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J
24: 28-66
[Full Text]
Petronio, A.S, Rovai, D, Musumeci, G, Baglini, R, Nardi, C, Limbruno, U, Palagi, C, Volterrani, D, Mariani, M
(2003). Effects of abciximab on microvascular integrity and left ventricular functional recovery in patients with acute infarction treated by primary coronary angioplasty. Eur Heart J
24: 67-76
[Abstract][Full Text]
Widimsky, P., Budesinsky, T., Vorac, D., Groch, L., Zelizko, M., Aschermann, M., Branny, M., St'asek, J., Formanek, P., on behalf of the 'PRAGUE' Study Group Investigator,
(2003). Long distance transport for primary angioplasty vs immediate thrombolysis in acute myocardial infarction: Final results of the randomized national multicentre trial--PRAGUE-2. Eur Heart J
24: 94-104
[Abstract][Full Text]
Lincoff, A. M., Califf, R. M., Van de Werf, F., Willerson, J. T., White, H. D., Armstrong, P. W., Guetta, V., Gibler, W. B., Hochman, J. S., Bode, C., Vahanian, A., Steg, P. G., Ardissino, D., Savonitto, S., Bar, F., Sadowski, Z., Betriu, A., Booth, J. E., Wolski, K., Waller, M., Topol, E. J., for the GUSTO V Investigators,
(2002). Mortality at 1 Year With Combination Platelet Glycoprotein IIb/IIIa Inhibition and Reduced-Dose Fibrinolytic Therapy vs Conventional Fibrinolytic Therapy for Acute Myocardial Infarction: GUSTO V Randomized Trial. JAMA
288: 2130-2135
[Abstract][Full Text]
Mahadevan, V. S., McCarty, D., Adgey, A. A. J.
(2002). Platelet GPIIb/IIIa receptor blockers for failed thrombolysis in acute myocardial infarction, alone or as adjunct to other rescue therapies. Eur Heart J
23: 1490-1491
[Full Text]
Rimar, D, Crystal, E, Battler, A, Gottlieb, S, Freimark, D, Hod, H, Boyko, V, Mandelzweig, L, Behar, S, Leor, J
(2002). Improved prognosis of patients presenting with clinical markers of spontaneous reperfusion during acute myocardial infarction. Heart
88: 352-356
[Abstract][Full Text]
Mehta, R. H., Criger, D. A., Granger, C. B., Pieper, K. K., Califf, R. M., Topol, E. J., Bates, E. R.
(2002). Patient outcomes after fibrinolytic therapy for acute myocardial infarction at hospitals with and without coronary revascularization capability. J Am Coll Cardiol
40: 1034-1040
[Abstract][Full Text]
Hsu, L F, Mak, K H, Lau, K W, Sim, L L, Chan, C, Koh, T H, Chuah, S C, Kam, R, Ding, Z P, Teo, W S, Lim, Y L
(2002). Clinical outcomes of patients with diabetes mellitus and acute myocardial infarction treated with primary angioplasty or fibrinolysis. Heart
88: 260-265
[Abstract][Full Text]
Selker, H. P., Beshansky, J. R., Griffith, J. L., for the TPI Trial Investigators*,
(2002). Use of the Electrocardiograph-Based Thrombolytic Predictive Instrument To Assist Thrombolytic and Reperfusion Therapy for Acute Myocardial Infarction: A Multicenter, Randomized, Controlled, Clinical Effectiveness Trial. ANN INTERN MED
137: 87-95
[Abstract][Full Text]
Widimsky, P.
(2002). Reperfusion damage or no-reflow damage in primary coronary interventions in acute myocardial infarction?. Eur Heart J
23: 1076-1078
[Full Text]
Goswami, N. J., Moody, J. M. Jr, Bailey, S. R.
(2002). Percutaneous Mechanical Reperfusion During Acute Myocardial Infarction. J Intensive Care Med
17: 162-173
[Abstract]
Grines, C. L., Westerhausen, D. R. Jr, Grines, L. L., Hanlon, J. T., Logemann, T. L., Niemela, M., Weaver, W. D., Graham, M., Boura, J., O'Neill, W. W., Balestrini, C., Air PAMI Study Group,
(2002). A randomized trial of transfer for primary angioplasty versus on-site thrombolysis in patients with high-risk myocardial infarction: The air primary angioplasty in myocardial infarction study. J Am Coll Cardiol
39: 1713-1719
[Abstract][Full Text]
Thiemann, D. R.
(2002). Primary angioplasty for elderly patients with myocardial infarction: Theory, practice and possibilities. J Am Coll Cardiol
39: 1729-1732
[Full Text]
Cohen, V., Murphy, D. G., Williams, J.
(2002). Review of the Current ACS Practice Guideline to Develop an Ischemic Chest Pain Protocol. Journal of Pharmacy Practice
15: 250-266
[Abstract]
Aversano, T., Aversano, L. T., Passamani, E., Knatterud, G. L., Terrin, M. L., Williams, D. O., Forman, S. A., for the Atlantic Cardiovascular Patient Outcomes R,
(2002). Thrombolytic Therapy vs Primary Percutaneous Coronary Intervention for Myocardial Infarction in Patients Presenting to Hospitals Without On-site Cardiac Surgery: A Randomized Controlled Trial. JAMA
287: 1943-1951
[Abstract][Full Text]
Zijlstra, F, Patel, A, Jones, M, Grines, C.L, Ellis, S, Garcia, E, Grinfeld, L, Gibbons, R.J, Ribeiro, E.E, Ribichini, F, Granger, C, Akhras, F, Weaver, W.D, Simes, R.J
(2002). Clinical characteristics and outcome of patients with early (<2h), intermediate (2-4h) and late (>4h) presentation treated by primary coronary angioplasty or thrombolytic therapy for acute myocardial infarction. Eur Heart J
23: 550-557
[Abstract][Full Text]
Luciardi, H., Berman, S., Muntaner, J., De La Serna, F., Altman, R.
(2002). Facilitated Thrombolysis: Dethrombosis?. CLIN APPL THROMB HEMOST
8: 133-138
[Abstract]
Estess, J M, Topol, E J
(2002). Fibrinolytic treatment for elderly patients with acute myocardial infarction. Heart
87: 308-311
[Full Text]
Elad, Y., French, W. J., Shavelle, D. M., Parsons, L. S., Sada, M. J., Every, N. R., Participants in the National Registry of Myocardia,
(2002). Primary angioplasty and selection bias inpatients presenting late (>12 h) after onset of chest pain and ST elevation myocardial infarction. J Am Coll Cardiol
39: 826-833
[Abstract][Full Text]
van den Brand, M. J. B. M., Rensing, B. J. W. M., Morel, M.-a. M., Foley, D. P., de Valk, V., Breeman, A., Suryapranata, H., Haalebos, M. M. P., Wijns, W., Wellens, F., Balcon, R., Magee, P., Ribeiro, E., Buffolo, E., Unger, F., Serruys, P. W.
(2002). The effect of completeness of revascularization on event-free survival at one year in the arts trial. J Am Coll Cardiol
39: 559-564
[Abstract][Full Text]
Moreno, R., Lopez-Sendon, J., Garcia, E., de Isla, L. P.e., de Sa, E. L.o., Ortega, A., Moreno, M., Rubio, R., Soriano, J., Abeytua, M., Garcia-Fernandez, M.-A.
(2002). Primary angioplasty reduces the risk of left ventricular free wall rupture compared with thrombolysis in patients with acute myocardial infarction. J Am Coll Cardiol
39: 598-603
[Abstract][Full Text]
Brener, S. J., Zeymer, U., Adgey, A. A. J., Vrobel, T. R., Ellis, S. G., Neuhaus, K.-L., Juran, N., Ivanc, T. B., Ohman, E. M., Strony, J., Kitt, M., Topol, E. J., for the INTRO AMI Investigators,
(2002). Eptifibatide and low-dose tissue plasminogen activator in acute myocardial infarction: The integrilin and low-dose thrombolysis in acute myocardial infarction (INTRO AMI) trial. J Am Coll Cardiol
39: 377-386
[Abstract][Full Text]
Corti, R., Fuster, V., Badimon, J.J.
(2002). Strategy for ensuring a better future for the vessel wall. Eur Heart J Suppl
4: A31-A41
[Abstract]
Loubeyre, C., Morice, M.-C., Lefevre, T., Piechaud, J.-F., Louvard, Y., Dumas, P.
(2002). A randomized comparison of direct stenting with conventional stent implantation in selected patients with acute myocardial infarction. J Am Coll Cardiol
39: 15-21
[Abstract][Full Text]
Savonitto, S., Granger, C. B., Ardissino, D., Gardner, L., Cavallini, C., Galvani, M., Ottani, F., White, H. D., Armstrong, P. W., Ohman, E. M., Pieper, K. S., Califf, R. M., Topol, E. J., GUSTO-IIb Investigators,
(2002). The prognostic value of creatine kinase elevations extends across the whole spectrum of acute coronary syndromes. J Am Coll Cardiol
39: 22-29
[Abstract][Full Text]
Buller, C. E., Carere, R. G.
(2002). New advances in the management of acute coronary syndromes: 3. The role of catheter-based procedures. CMAJ
166: 51-61
[Full Text]
Sciagra, R., Sestini, S., Bolognese, L., Cerisano, G., Buonamici, P., Pupi, A.
(2002). Comparison of Dobutamine Echocardiography and 99mTc-Sestamibi Tomography for Prediction of Left Ventricular Ejection Fraction Outcome After Acute Myocardial Infarction Treated with Successful Primary Coronary Angioplasty. JNM
43: 8-14
[Abstract][Full Text]
Taylor, A. J., Bobik, A., Berndt, M. C., Ramsay, D., Jennings, G.
(2002). Experimental Rupture of Atherosclerotic Lesions Increases Distal Vascular Resistance: A Limiting Factor to the Success of Infarct Angioplasty. Arterioscler. Thromb. Vasc. Bio.
22: 153-160
[Abstract][Full Text]
McNeil, B. J.
(2001). Hidden Barriers to Improvement in the Quality of Care. NEJM
345: 1612-1620
[Full Text]