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(Circulation. 1999;99:1548-1554.)
© 1999 American Heart Association, Inc.
Clinical Investigation and Reports |
Clinical and Angiographic Follow-Up After Primary Stenting in Acute Myocardial Infarction
The Primary Angioplasty in Myocardial Infarction (PAMI) Stent Pilot Trial
From the Washington Hospital Center, Washington, DC (G.W.S.); Moses Cone Hospital, Greensboro, NC (B.R.B.); Virginia Beach General Hospital, Virginia Beach, Va (J.J.G.); Hospital Santa Case de Misericordia, Curitiba, Brazil (C.C.); Institut Cardiovasculaire Paris Sud, Antony, France (M.C.M.); The Cardiovascular Institute, El Camino Hospital, Mountain View, Calif (F.G.S.G., J.M.); St. Mary of the Plains, Lubbock, Tex (P.A.O.); Brigham and Women's Hospital, Boston, Mass (J.J.P.); and the Division of Cardiology, William Beaumont Hospital, Royal Oak, Mich (D.J., W.W.O, C.L.G.).
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Abstract |
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Background—Restenosis has been reported in as many as 50% of patients within 6 months after PTCA in acute myocardial infarction (AMI), which necessitates repeat target-vessel revascularization (TVR) in
20% of
patients during this time period. Routine (primary) stent implantation
after PTCA has the potential to further improve late outcomes. Methods and Results—Primary stenting was performed as part of a prospective study in 236 consecutive patients without contraindications who presented with AMI of <12 hours' duration at 9 international centers. A mean of 1.4±0.7 stents were implanted per patient (97% Palmaz-Schatz) at 17.3±2.4 atm. During a clinical follow-up period of 7.4±2.6 months, death occurred in 4 patients (1.7%), reinfarction occurred in 5 patients (2.1%), and TVR was required in 26 patients (11.1%). By Cox regression analysis, small reference-vessel diameter and the number of stents implanted were the strongest determinants of TVR. Angiographic restenosis occurred in 27.5% of lesions. By multiple logistic regression analysis, the number of stents implanted and the absence of thrombus on the baseline angiogram were independent determinants of binary restenosis.
Conclusions—A strategy of routine stent implantation during mechanical reperfusion of AMI is safe and is associated with favorable event-free survival and low rates of restenosis compared with primary PTCA alone.
Key Words: angioplasty • restenosis • myocardial infarction • revascularization • stents
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Introduction |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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Although the 30-day rates of death, reinfarction, and stroke are improved after primary PTCA compared with thrombolytic therapy,1 angiographic restenosis occurs in up to 50% of patients, which necessitates target-vessel revascularization (TVR) of the infarct artery with either repeat percutaneous intervention or CABG in
20% of patients within this time
frame.2 3 4 5 6 Compared with balloon angioplasty in patients
undergoing elective coronary intervention, the implantation of
coronary stents has been shown to reduce the angiographic rate
of restenosis and improve late outcomes. Scant long-term data
exist, however, on late outcomes after stenting during acute myocardial
infarction (AMI). The Primary Angioplasty in Myocardial Infarction (PAMI) Stent Pilot Trial was a prospective, controlled, multicenter study designed to investigate the feasibility, safety, and long-term outcomes of a routine (primary) stent strategy in AMI in a large, consecutive series of patients.7 With 236 patients stented, this trial represents the largest experience with AMI stenting to date. The present report describes the major end points of this study, which were the late clinical and angiographic outcomes.
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Methods |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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Patients and Clinical Centers
The methodology has been described previously in detail.7 Nine clinical sites in the United States, Europe, and South America participated in this prospective study, which was approved by the investigational review boards of the participating hospitals. Consecutive patients of any age with symptom duration
12
hours with any ECG pattern of AMI were enrolled. Patients were excluded
for cardiogenic shock; for absolute contraindications to heparin,
aspirin, or ticlopidine; and for prior use of
thrombolytic therapy during the same hospitalization.
All patients provided informed, written consent before enrollment.
Study Protocol
After receiving aspirin, ticlopidine, and heparin in the emergency
room, patients were transferred to the catheterization
laboratory, and primary PTCA was performed as previously
described.7 After restoration of flow, stent implantation
was attempted in all eligible lesions. Stenting was deferred if the
reference segment was visually <3.0 or >4.0 mm in diameter, if
the lesion would require 
3 stents for coverage, if stenting would
compromise a major side branch, if the infarct lesion was a true ostial
left anterior descending coronary or left circumflex artery
lesion, or if excessive proximal tortuosity or lesion calcification was
present. Stenting was routinely performed directly into small or
moderate amounts of thrombus but was deferred in 5 patients (1.6%) for
large thrombus burden refractory to PTCA or pharmacological
treatment.
Postprocedure medications consisted of oral aspirin 325 mg/d PO indefinitely, ticlopidine 250 mg PO BID for 4 weeks, and a 60-hour tapering heparin regimen (48 hours of full dose after sheath removal to keep the activated partial thromboplastin time at 55 to 80 seconds, followed by 12 hours of half dose, a schedule empirically derived to offset the frequently present rebound hypercoagulable state8 ). Clinical follow-up visits were scheduled at 1 and 6 months. Protocol follow-up angiography was planned after the 6-month visit in all surviving patients in whom CABG was not performed before hospital discharge, provided that restenosis had not already been documented.
Definitions
The primary end point of the study was the 6-month rate of adverse
clinical events (death, reinfarction, and TVR); angiographic
restenosis was a secondary end point. Reinfarction was defined
as recurrent ischemic symptoms or ECG changes, with any
creatine kinase–MB reelevation. TVR was defined as the
performance of repeat percutaneous intervention
or CABG of the infarct vessel after the index procedure. Thrombus was
defined by the core laboratory as the presence of discrete intraluminal
filling defects or lucency outlined by contrast material or of a convex
leading edge with staining or haziness if the vessel was occluded.
Binary restenosis was defined as present when the diameter
stenosis within the axial length of the stent was >50%.
Data Collection and Statistical Analysis
Detailed in-hospital, 1-month, and 6-month follow-up case report
forms were prospectively completed for each patient. Clinical events
were confirmed and adjudicated at the coordinating center by separate
review of all catheterization reports, ECGs, laboratory
tests, and discharge summaries. Quantitative coronary
analysis of all index and follow-up films was performed by an
independent core angiographic laboratory at the Washington Hospital
Center using previously validated methodology.9
Clinical and angiographic data were entered into a computerized
database, and statistical analysis was performed with
commercially available software (JMP 3.1, SAS Institute). Categorical
variables were compared with 
2 or
Fisher's exact tests, whereas continuous variables were compared
with paired or unpaired Student t tests. Follow-up clinical
events were analyzed with actuarial methods, and Kaplan-Meier
curves were constructed. The influence of 25 baseline demographic and
angiographic variables on late clinical events during the follow-up
period was assessed with the log rank test. Cox proportional hazard
regression was then used to determine the independent predictors of
late adverse events.
Baseline, postprocedural, and follow-up angiographic core laboratory measures were displayed as a cumulative frequency distribution function. The independent correlates of angiographic binary restenosis were evaluated by multiple logistic regression analysis. The independent predictors of the follow-up diameter stenosis considered as a continuous variable were determined by stepwise forward regression analysis. A P value of <0.05 was required for statistical significance.
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Results |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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Patients and Catheterization Laboratory Course
Between June 1995 and July 1996, stenting was considered feasible and was attempted in 240 (77%) of 312 consecutive patients undergoing primary PTCA at 9 clinical centers; as previously described, the most common reasons for not stenting (72 lesions) were small vessels, excessive lesion length, proximal tortuosity, and major side-branch involvement.7 Stents were successfully implanted in 236 patients (98%), who constitute the study cohort for long-term analysis. The baseline demographic, clinical, and angiographic features of the patient population have been described previously.7 A mean of 1.4±0.7 stents (range, 1 to 7) were implanted per patient (97% JJIS, 1% AVE, 1% Cook, and 1% Schneider). The median balloon size used for post–stent-implantation expansion was 3.4±0.5 mm (mean balloon-to-artery ratio 1.10±0.17) at 17.3±2.4 atm.
In-Hospital and Follow-Up Clinical Events
Two patients (0.8%) died before hospital discharge, 1 after a
reinfarction 7 days after stenting and 1 of left
ventricular failure on hospital day 4 despite
angiographically successful stenting. Of 234 stented patients who were
discharged from the hospital alive, clinical follow-up was available in
100% at a mean time of 7.4±2.6 months. Adverse clinical events are
summarized in Table 1
, and
actuarial event-free survival curves are displayed in Figure 1. Of note, TVR was performed in 34 of 35
patients for clinical symptoms or recurrent ischemia; in only 1
case was TVR performed in an asymptomatic patient on the
basis of the findings of protocol follow-up angiography (the
"oculo-stenotic reflex").
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By univariate analysis, the presence of
triple-vessel disease, reference-vessel diameter <3.1 mm,
postprocedural minimal lumen diameter <2.72 mm, and the inability
to restore TIMI-3 flow correlated with the occurrence of the composite
end point of in-hospital or late death, reinfarction, or TVR after
stenting in AMI (Figure 2, left). By Cox
multivariate regression analysis, only
restoration of TIMI-3 flow was independently predictive of event-free
survival (OR [95% CI]=3.2 [1.1, 9.0]; P=0.02). Three
univariate correlates of postdischarge TVR (ie, clinical
restenosis) were identified: the number of stents implanted,
the reference-segment diameter, and the presence of triple-vessel
disease (Figure 2, right). By Cox regression analysis,
the only independent determinant for the occurrence of TVR after
hospital discharge was smaller reference-vessel diameter (OR=2.2 [1.1,
4.6]; P=0.03); the number of stents implanted retained
borderline statistical significance in this model (OR=2.0 [0.9, 4.8];
P=0.08), whereas triple-vessel disease was no longer
predictive of TVR (OR=1.7 [0.7, 3.4]; P=0.15).
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Acute and Follow-Up Angiography
Of 229 stented patients surviving to hospital discharge without
bypass surgery, angiographic follow-up was performed in 176 (77.0%) at
a mean time of 7.8±3.2 months. There were no significant differences
in baseline characteristics, initial angiographic results, or
in-hospital outcomes between eligible patients with versus without
angiographic follow-up, except for a slightly greater incidence of
diabetes in patients who underwent late angiography (Table 2). The follow-up angiograms from 1 site
were recorded on a CD-ROM format, which proved to be incompatible
with the core laboratory digital acquisition protocols; the cases from
this single site were thus excluded from further angiographic
analysis (Figure 3).
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The preprocedure, acute poststenting, and follow-up angiographic
quantitative coronary analysis measures in 142 patients
with paired core laboratory data appear in Table 3 and Figure 4. Binary restenosis was
present in 27.5% of infarct arteries, including reocclusion in
6.4% of infarct vessels. The univariate and
multivariate correlates of angiographic
restenosis appear in Table 4. By
multiple logistic regression analysis, the only independent
predictors of binary restenosis were the absence of thrombus
before stenting and the number of stents implanted. When considered as
a continuous variable in a stepwise, forward regression
analysis, the independent correlates of greater diameter
stenosis at follow-up were a smaller balloon-to-artery ratio,
the absence of thrombus before stenting, and the number of stents
implanted. The impact of the number of stents implanted on clinical and
angiographic restenosis is shown in Figure 5.
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Discussion |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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Clinical Outcomes After Primary Stenting in AMI
The principal finding from this prospective, multicenter study is that a primary stent strategy in AMI at experienced centers is safe and results in favorable intermediate-term clinical outcomes. Most events during the follow-up period consisted of repeat TVRs, with few patients dying or experiencing reinfarction. The actuarial postdischarge 6-month TVR rate of 11.7% after primary AMI stenting in this study is similar to that reported after elective stenting in the noninfarct setting10 11 and compares favorably to the 6-month TVR rates reported after primary PTCA for AMI (21.7% from the Primary Angioplasty Registry,5 17.1% from the PAMI trial,12 and 17.0% in the series by Hartzler et al13 ). It must be emphasized, however, that in addition to "stent-eligible" lesions, primary PTCA is also typically performed in stenoses not amenable to stenting (eg, in diffuse disease and in smaller vessels), which may have a higher restenosis rate. Thus, large-scale, multicenter randomized trials are necessary to confirm whether late event rates are indeed lower after primary stenting than after primary PTCA, as suggested from the present study.
Reference-vessel diameter and number of stents implanted were
found to be the predominant determinants of freedom from late TVR
(clinical restenosis) after primary stenting in AMI (Figure 2
, right). Small vessel size14 15 and multiple
stent implantation15 16 are also well-recognized risk
factors for clinical and angiographic restenosis after elective
coronary stenting. When total late composite outcomes were
considered, including in-hospital death, reinfarction, and TVR,
restoration of TIMI-3 flow proved to be the strongest determinant of
event-free survival (Figure 2, left). The fundamental
relationship between the establishment of TIMI-3 flow and reduced
short-term mortality17 18 and reinfarction12
after primary PTCA in AMI has been described previously and appears to
be equally important after a primary stent strategy.
Angiographic Restenosis After Primary Stenting in
AMI
Five prior studies (with 85 to 154 patients each) have reported
the 6-month angiographic rates of restenosis and reocclusion
after primary PTCA.5 19 20 21 22 With angiographic follow-up
performed in 70% to 89% of patients in these series,
restenosis was documented in 37% to 49% of vessels, including
infarct artery reocclusion in 9% to 14%. In contrast,
restenosis was found in 27.5% of vessels after primary
stenting in the present study, including infarct artery reocclusion
in 6.4%. Thus, these data support the contention that routine stenting
of the infarct vessel during AMI may improve long-term vessel patency
and reduce restenosis compared with primary PTCA alone.
However, given differing baseline lesion characteristics and vessel
eligibility between the primary stent and primary PTCA populations,
randomized trials are necessary before this issue can be considered
resolved.
In addition to being predictive of the need for late clinical TVR, the number of stents implanted was identified as an independent correlate of angiographic restenosis, consistent with previous studies of elective stenting.15 16 However, given the high percentage of patients with occluded coronary vessels, it was impossible to accurately quantify baseline lesion length in 40% of the patients in the present study. It therefore cannot be differentiated whether the number of stents implanted is truly an independent risk factor for TVR and restenosis after AMI stenting or merely represents a surrogate for lesion length. The only other variable related to restenosis was the absence of angiographically visible thrombus before intervention. To the best of our knowledge, this finding has not been described before with elective stenting (possibly because of the rarity of stenting thrombotic lesions in most prior studies). It is well known that thrombus is present in the majority of infarct-related lesions, although it is angiographically evident in only a minority of cases.23 Although it remains speculative why angiographically visible thrombus was protective against restenosis in the present study, it is possible that the presence of abundant angiographic thrombus may signify lesser underlying plaque burden, thereby engendering greater long-term freedom from restenosis after stenting.24
Comparison With Previous Primary Stent Studies
Three smaller single-center studies (72 to 124 patients each) have
been published examining late clinical and angiographic outcomes after
Palmaz-Schatz stenting in AMI,25 26 27 none of which were
adequately powered to analyze the multivariate
correlates of late TVR and restenosis. Considering only the
patients in these studies treated with aspirin and ticlopidine, the
6-month reported composite rates of death, reinfarction or TVR ranged
between 13.5% and 18.0%. Two of these studies25 26
incorporated routine angiographic follow-up at 6 months and documented
restenosis rates ranging from 19.0% to 26.5% and
infarct-artery reocclusion rates of 1.0% to 1.6%. Thus, the 17.4%
incidence of late clinical events and 27.5% restenosis rate
(including 6.4% vessel reocclusion) from the present multicenter
PAMI Stent Pilot Trial are at the high end of the prior reports and
probably accurately reflect the late clinical and angiographic outcomes
that can be expected when primary stenting is performed by multiple
operators at various institutions in a largely unselected patient
population.
In contrast, the 6-month cardiac event-free rate after primary stenting in 115 patients with AMI was 95% in the recently published single-center randomized trial by Suryapranata and colleagues,28 with a separately reported restenosis rate of only 11%. However, only 50% of screened patients were enrolled in that trial, compared with 77% of patients in the PAMI Stent Pilot Trial.7 The improved results in the study by Suryapranata et al28 may therefore represent selective enrollment of a lower-risk patient cohort, as well as the possible play of chance, reemphasizing the importance of large-scale, multicenter randomized trials.
Study Limitations and Clinical Caveats
First, although the present trial, with 236 consecutive
eligible patients stented, represents the largest experience to
date of stenting during evolving AMI, an expanded patient population
might have allowed the elucidation of other variables related to
clinical and angiographic restenosis. Second, the favorable
results of this study cannot be generalized to patient or lesion
subtypes excluded from randomization, including patients in cardiogenic
shock and infarct-related lesions >25 mm in length or in vessels
2.5 mm in diameter. Similarly, the clinical and angiographic
outcomes reported from this trial apply primarily to the
balloon-expandable Palmaz-Schatz stent; whether newer, more flexible
designs (without a central articulation) can surpass these event rates
will require independent appraisal. Furthermore, the optimal
postprocedural pharmacological regimen after primary infarct stenting
has not been determined; it is unresolved, for example, whether the
60-hour tapering heparin regimen routinely used in all the recent PAMI
studies is beneficial or necessary. Third, intravascular ultrasound was
not routinely used to guide stent implantation in the present
study. It is unknown whether the regular use of intravascular
ultrasound would have identified additional predictive determinants of
clinical or angiographic outcomes or would have led to improved
results. Fourth, although the actual rate of completed angiographic
follow-up was 77%, fewer films were available for paired acute and
late angiographic core laboratory analysis. Because most of the
nonexamined films were systematically not analyzable for technical
reasons (despite completion of angiographic follow-up), the remainder
should be representative of the entire population.
Furthermore, the primary end point of the study was the incidence of
late clinical adverse events, and clinical follow-up was obtained in
100% of patients; the secondary angiographic data are
consistent with and support the clinical outcomes end
point.
Finally, given the hazards of comparing registry experiences with
historical controls and the lack of data regarding the
cost-effectiveness of a primary stent approach relative to PTCA, it is
prudent to currently reserve stenting during AMI for suboptimal
procedural PTCA outcomes (ie, a residual stenosis >30% or
dissection type B), despite the encouraging results of this trial.
Ongoing large-scale, international, multicenter randomized trials,
including the 900-patient PAMI Stent Randomized Trial and the
2000-patient Controlled Abciximab and Device Evaluation to Lower
Late Angioplasty Complications (CADILLAC) trial, should provide
additional meaningful insight as to whether primary stenting indeed
represents a major breakthrough in the reperfusion therapy of
patients with AMI.
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Acknowledgments |
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Funding for this study was provided in part by an unrestricted grant from Johnson and Johnson Interventional Systems, Warren, NJ.
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Footnotes |
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Reprint requests to Dr Gregg W. Stone, Cardiology Research Foundation, Washington Hospital Center, 110 Irving St NW, Suite 4B-1, Washington DC, 20010.
A complete list of contributors appears in Reference 7.
Received August 6, 1998; revision received December 7, 1998; accepted December 18, 1998.
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P. Garot, T. Lefevre, H. Eltchaninoff, M.-C. Morice, F. Tamion, B. Abry, P.-F. Lesault, J.-Y. Le Tarnec, C. Pouges, A. Margenet, et al. Six-Month Outcome of Emergency Percutaneous Coronary Intervention in Resuscitated Patients After Cardiac Arrest Complicating ST-Elevation Myocardial Infarction Circulation, March 20, 2007; 115(11): 1354 - 1362. [Abstract] [Full Text] [PDF]
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A-A Fassa, P Urban, D Radovanovic, N Duvoisin, J-M Gaspoz, J-C Stauffer, P Erne, and for the AMIS Plus Investigators Trends in reperfusion therapy of ST segment elevation myocardial infarction in Switzerland: six year results from a nationwide registry Heart, July 1, 2005; 91(7): 882 - 888. [Abstract] [Full Text] [PDF]
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P. S. Heggunje, K. J. Harjai, G. W. Stone, R. H. Mehta, D. L. Marsalese, J. A. Boura, W. W. O'Neill, and C. L. Grines Procedural success versus clinical risk status in determining discharge of patients after primary angioplasty for acute myocardial infarction J. Am. Coll. Cardiol., October 6, 2004; 44(7): 1400 - 1407. [Abstract] [Full Text] [PDF]
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C. O. Costantini, G. W. Stone, R. Mehran, E. Aymong, C. L. Grines, D. A. Cox, T. Stuckey, M. Turco, B. J. Gersh, J. E. Tcheng, et al. 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., July 21, 2004; 44(2): 305 - 312. [Abstract] [Full Text] [PDF]
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G Montalescot, H R Andersen, D Antoniucci, A Betriu, M J de Boer, L Grip, F J Neumann, and M T Rothman Recommendations on percutaneous coronary intervention for the reperfusion of acute ST elevation myocardial infarction Heart, June 1, 2004; 90(6): e37 - e37. [Abstract] [Full Text] [PDF]
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R. H. Mehta, K. J. Harjai, L. Grines, G. W. Stone, J. Boura, D. Cox, W. O'Neill, C. L. Grines, and Primary Angioplasty in Myocardial Infarction (PAMI 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., May 19, 2004; 43(10): 1765 - 1772. [Abstract] [Full Text] [PDF]
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R. H. Mehta, K. J. Harjai, D. Cox, G. W. Stone, B. Brodie, J. Boura, W. O'Neill, C. L. Grines, and Primary Angioplasty in Myocardial Infarction (PAMI Clinical and angiographic correlates and outcomes of suboptimal coronary flow inpatients with acute myocardial infarction undergoing primary percutaneous coronary intervention J. Am. Coll. Cardiol., November 19, 2003; 42(10): 1739 - 1746. [Abstract] [Full Text] [PDF]
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D. J. Moliterno and A. W. Chan Glycoprotein IIb/IIIa inhibition in early intent-to-stent treatment of acute coronary syndromes: EPISTENT, ADMIRAL, CADILLAC, and TARGET J. Am. Coll. Cardiol., February 19, 2003; 41(4_Suppl_S): 49S - 54S. [Abstract] [Full Text] [PDF]
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M. N. Babapulle and M. J. Eisenberg Coated Stents for the Prevention of Restenosis: Part II Circulation, November 26, 2002; 106(22): 2859 - 2866. [Full Text] [PDF]
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A. Colombo, G. Stankovic, and J. W. Moses Selection of coronary stents J. Am. Coll. Cardiol., September 18, 2002; 40(6): 1021 - 1033. [Abstract] [Full Text] [PDF]
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H. Sasao, A. Endo, T. Hasegawa, Y. Ichikawa, R. Noda, H. Oimatsu, and T. Takada Long-Term Follow-up After Coronary Stent Implantation in Patients with Coronary Artery Disease Angiology, March 1, 2002; 53(2): 149 - 156. [Abstract] [PDF]
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G. W. Stone, D. Cox, E. Garcia, B. R. Brodie, M.-C. Morice, J. Griffin, L. Mattos, A. J. Lansky, W. W. O'Neill, and C. L. Grines Normal Flow (TIMI-3) Before Mechanical Reperfusion Therapy Is an Independent Determinant of Survival in Acute Myocardial Infarction: Analysis From the Primary Angioplasty in Myocardial Infarction Trials Circulation, August 7, 2001; 104(6): 636 - 641. [Abstract] [Full Text] [PDF]
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C. Stefanadis, K. Toutouzas, E. Tsiamis, C. Stratos, M. Vavuranakis, I. Kallikazaros, D. Panagiotakos, and P. Toutouzas Increased local temperature in human coronary atherosclerotic plaques: an independent predictor of clinical outcome in patients undergoing a percutaneous coronary intervention J. Am. Coll. Cardiol., April 1, 2001; 37(5): 1277 - 1283. [Abstract] [Full Text] [PDF]
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K.-H. Mak and E. J. Topol Emerging concepts in the management of acute myocardial infarction in patients with diabetes mellitus J. Am. Coll. Cardiol., March 1, 2000; 35(3): 563 - 568. [Abstract] [Full Text] [PDF]
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