Influence of Balloon Pressure During Stent Placement in

Native Coronary Arteries on Early and Late Angiographic

and Clinical Outcome
A Randomized Evaluation of High-Pressure Inflation
Josef Dirschinger, MD; Adnan Kastrati, MD; Franz-Josef Neumann, MD; Peter Boekstegers, MD;
Shpend Elezi, MD; Julinda Mehilli, MD; Helmut Schühlen, MD; Jürgen Pache, MD; Eckhard Alt, MD;
Rudolf Blasini, MD; Gerhard Steinbeck, MD; Albert Schömig, MD

Background—High-pressure dilatation is considered a better stent placement strategy, but this has not yet been proved by
appropriately designed studies. The objective of this randomized trial was to assess the role of high-pressure dilatation
in the early and late outcome of patients undergoing coronary stent placement.
Methods and Results—Consecutive patients with coronary stent placement were randomly assigned to high- (15 to 20 atm,
468 patients) or low- (8 to 13 atm, 466 patients) balloon-pressure dilatation. The primary end point of the study was the
event-free survival at 1 year. Secondary end points were the incidence of stent thrombosis at 30 days and angiographic
restenosis ($50% diameter stenosis) at 6 months. The incidence of stent thrombosis was 1.7% in the high-pressure and
1.9% in the low-pressure group (relative risk 0.89; 95% CI 0.30 to 2.56). During the first 30 days, although there was
no significant difference in the incidence of Q-wave myocardial infarction, the incidence of non–Q-wave infarction was
6.4% in the high-pressure and 3.4% in the low-pressure group (relative risk 1.87; 95% CI 1.02 to 3.42). The restenosis
rate was 30.4% in the high-pressure and 31.4% in the low-pressure group (relative risk 0.97; 95% CI 0.75 to 1.26).
Event-free survival at 1 year was not significantly different between the groups, with 78.8% in high-pressure patients
and 75.5% in patients assigned to low-pressure dilatation (hazard ratio 0.85; 95% CI 0.65 to 1.11).
Conclusions—The systematic use of high-balloon-pressure inflation (15 to 20 atm) during coronary stent placement is not
associated with any significant influence on the 1-year outcome of patients undergoing this intervention. (Circulation.
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1999;100:918-923.)
Key Words: stents n balloon n thrombosis n restenosis n trials

T he enthusiasm engendered by the initial randomized

trials demonstrating the advantages of coronary stenting
over conventional percutaneous transluminal balloon angio-
plasty (PTCA) was overshadowed by the increase in bleeding
complications associated with the anticoagulation therapy
imposed by the thrombogenic nature of the stent.1,2 Improve-
ment in the rheology of the stented coronary lumen3 was a
first logical attempt to reduce the risk of stent thrombosis and
the need for aggressive anticoagulation. Colombo and his
team4,5 were the first to propose high-pressure dilatation as a
strategy that ensures complete stent apposition, better flow
characteristics, and decreased risk of thrombosis and obviates
the anticoagulation. This strategy was rapidly embraced by
the large community of interventional cardiologists and
became an integral part of recent recommendations on coro-
nary stenting.6 The switch to the high-pressure strategy,
however, has coincided with the introduction of ticlopidine
plus aspirin as a poststenting therapy. The demonstration of
the pivotal role of platelets in stent thrombosis7,8 and of the
superiority of the combined antiplatelet therapy over antico-
agulation for its prevention9,10 necessitates specifically de-
signed studies to clarify the independent role of high-pressure
dilatation in the reduction of the risk for stent thrombosis.
High-pressure dilatation may also exert a positive influence
on restenosis as a result of the better acute lumen achieved11
and improvement in flow characteristics.12
The objective of this randomized trial was to assess the role
of high-pressure dilatation in the early and late outcome of
patients undergoing coronary stent placement.
Methods
Patients
Patients with symptomatic coronary artery disease treated with
stenting were eligible for this study. Exclusion criteria were acute

Received January 14, 1999; revision received May 24, 1999; accepted June 2, 1999.
From the 1. Medizinische Klinik rechts der Isar der Technischen Universität (J.D., H.S., J.P., E.A.); the Deutsches Herzzentrum (A.K., F.J.N., S.E.,
J.M., R.B., A.S.); and the 1. Medizinische Klinik, Klinikum Großhadern der Ludwig-Maximilians-Universität (P.B., G.S.), Munich, Germany.
Correspondence to Dr Josef Dirschinger, 1. Medizinische Klinik rechts der Isar der TU, Ismaningerstraße 22, 81675 München, Germany.
© 1999 American Heart Association, Inc.
Circulation is available at http://www.circulationaha.org

918
 Dirschinger et al High- vs Low-Pressure Coronary Stenting 919

3myocardial infarction (within 48 hours before intervention), target TABLE 1. Baseline Clinical Characteristics
lesion in a venous bypass graft, prior randomization, and unwilling-
ness or inability to provide written informed consent for participation High Pressure Low Pressure
in the trial. The randomization sequence was specified before the (n5468) (n5466)
study began. All patients were randomly assigned to a balloon- Age, y 64.6610.5 64.2610.6
pressure strategy by means of sealed envelope before the interven-
tion. Patients gave informed consent for a routine control angiogra- Women 24.8 23.6
phy at 6 months. The study was conducted according to the Arterial hypertension 67.7 71.2
principles of the Declaration of Helsinki and was approved by the Diabetes 20.7 21.5
Ethics Committees at each participating center.
Smoking 30.8 32.0
Stent Placement and Poststenting Treatment Hypercholesterolemia 38.7 35.0
During the intervention, patients received intravenous heparin and Unstable angina 30.8 29.2
aspirin. Patients considered at higher risk for stent thrombosis (large
Previous PTCA 10.5 14.4
residual dissections, thrombus at the stent site) received abciximab.
Heparin infusion was continued for 12 hours after the intervention. Previous CABG 6.6 8.4
All patients received 250 mg ticlopidine started immediately after the Reduced left ventricular function 46.8 48.3
intervention and continued twice daily for 4 weeks as well as 100 mg
Number of diseased vessels
aspirin taken twice daily indefinitely.
The stents implanted were those in use in our institutions at the Single-vessel disease 31.8 29.8
time at which the study was performed. They were all composed of Two-vessel disease 32.5 32.8
stainless steel material and were multicellular in design. We used the
Three-vessel disease 35.7 37.4
Inflow stent (Inflow Dynamics), Multi-Link stent (Guidant, Ad-
vanced Cardiovascular Systems), NIR stent (Scimed, Boston Scien- Data are mean6SD or percentages.
tific), Palmaz-Schatz stent (Johnson & Johnson Interventional Sys-
tems), and Pura-A stent (Devon Medical). Lesion predilatation with prolonged chest pain and a rise in serum creatine kinase (CK) levels
conventional angioplasty balloon catheters was performed before the to at least twice the upper normal limit or the appearance of $1 new
stent placement. Except for the Multi-Link type, all stents were pathological Q waves on the ECG.14 CK was determined before and
firmly hand-crimped on conventional balloon catheters before deliv- immediately after the procedure, every 8 hours for the first 24 hours
ery. For Multi-Link stents, the delivery system provided by the after stenting, and then daily until discharge. Target vessel revascu-
manufacturer was used. The balloon size for stent deployment was larization was performed in the presence of angiographic restenosis
chosen on the basis of the estimated vessel size in a nondiseased and symptoms or signs of ischemia. Cardiac events were monitored
portion. High pressure was defined as a pressure in the range of 15 throughout the follow-up period. The assessment was made on the
to 20 atm on the basis of the values used by Colombo et al4,5 and basis of the information provided by hospital readmission records,
achieved with noncompliant or minimally compliant balloons. Low
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pressure was defined as a pressure in the range of 8 to 13 atm to
allow a safe inflation with conventional angioplasty balloons below
the rated burst pressure. The procedural results were assessed by
angiography only; no intravascular ultrasound studies were per-
formed. The procedure was considered successful when stent place-
ment was associated with a residual stenosis of ,30% and Throm-
bolysis in Myocardial Infarction (TIMI) flow grade $2.
Angiographic Evaluation
Lesion complexity and calcifications were defined according to Ellis
et al.13 Left ventricular function was assessed qualitatively on the
basis of biplane angiograms with a 7-segment division; the diagnosis
of reduced left ventricular function required the presence of hypo-
kinesia in $2 segments. Offline quantitative angiographic analysis
was performed by operators not involved in the procedure and
unaware of the pressure strategy to which the patient was assigned.
Digital angiograms were analyzed with the automated edge detection
system CMS (Medis Medical Imaging Systems). Matched views
were selected for angiograms recorded before and immediately after
the intervention and at follow-up. The parameters obtained were
minimal lumen diameter (MLD), reference diameter, diameter ste-
nosis, and diameter of the maximally inflated balloon during stent
placement. Acute elastic recoil was measured as the difference
between balloon diameter and MLD at the end of the procedure.
Acute lumen gain was the difference between MLD at the end of the
intervention and MLD before balloon dilatation. Late lumen loss was
calculated as the difference in MLD between immediately after the
procedure and follow-up.
Definitions and End Points of the Study
The primary end point of the study was event-free survival at 1 year
after the procedure. Death, myocardial infarction, and target vessel
revascularization (PTCA or aortocoronary bypass surgery) were
considered adverse events. The diagnosis of acute myocardial
infarction was established in the presence of a clinical episode of
referring physician, or phone interview with the patient. For all those
patients who showed cardiac symptoms during the interview, at least
a clinical and ECG checkup was performed at the outpatient clinic or
by the referring physician.
Secondary end points of the study were based on angiographic
outcomes after stenting. First, the incidence of stent thrombosis was
assessed during the early 30-day period. The diagnosis was made on
the basis of a TIMI flow grade of 0 or 1 at angiography. Second, the
incidence of restenosis (defined as a diameter stenosis of $50%) was
assessed from the 6-month follow-up angiography.
Statistical Analysis
The number of patients included in the study was based on the
sample size estimation for our primary end point, the occurrence of
any major adverse event during the first year after the procedure. We
assumed a 1-year event rate of 20% for patients with low-pressure
stenting and 13% for those with high-pressure dilatation. The study
was designed to have an 80% power for detecting a significant
difference between these 2 strategies with an a level of 0.05, and a
sample size of 466 patients for each group was estimated.
All analyses were performed on an intention-to-treat basis. Results
are expressed as mean6SD or as proportions (%). The differences
between groups were assessed by x2 test for categorical data and t
test for continuous data. The relative risk for an adverse event
associated with high-pressure inflation was also calculated. Survival
analysis was made by the Kaplan-Meier method. Differences in
survival parameters were assessed for significance by means of the
log-rank test, and the hazard ratio associated with high-pressure
inflation was calculated by Cox regression analysis. Statistical
significance was accepted for all values of P,0.05.
Results
Of the 934 patients enrolled in the study, 468 were assigned
to high-pressure and 466 to low-pressure dilatation. Table 1
shows the baseline clinical characteristics of the patients,
 920 Circulation August 31, 1999

TABLE 2. Baseline Angiographic Characteristics

High Pressure Low Pressure
(n5468) (n5466)
Vessel
Left main 1.9 1.3
LAD 44.4 44.2
LCx 19.5 20.8
RCA 34.2 33.7
ACC/AHA lesion type
A 9.0 10.9
B1 25.4 29.6
B2 48.5 44.0 Figure 1. Histogram of actual balloon pressures used in each
randomization arm.
C 17.1 15.5
Calcified lesions 18.2 15.2
Chronic occlusions 7.7 5.8
considered it more appropriate to use a pressure above the
range specified in the study protocol because of suboptimal
Ostial lesions 6.6 6.9
angiographic results. In 24 of these 45 patients (53%), the
Lesion length, mm 11.565.7 10.965.5
balloon pressure used was only 1 atm above the upper limit of
Vessel size, mm 2.9860.50 2.9460.46
13 atm, ie, intermediate between low and high pressure. In 48
Preprocedural diameter stenosis, % 75.0614.2* 72.6615.0 patients of the high-pressure group, the operator used a
LAD indicates left anterior descending coronary artery; LCx, left circumflex pressure below the range specified in the study protocol
coronary artery; RCA, right coronary artery; and ACC/AHA, American College of because of increased risk or presence of a progressive
Cardiology/American Heart Association. Data are mean6SD or percentages.
*P,0.05 vs low-pressure group.
dissection or when it was impossible or hazardous to reach
the stented lesion with an additional noncompliant balloon. In
20 of these 48 patients (42%), the balloon pressure used was
which were comparable between the groups. Table 2 lists the
only 1 atm below the lower limit of 15 atm, ie, intermediate
baseline angiographic characteristics of the patients. Diame-
between low and high pressure. Thus, in 6.0% of high-
ter stenosis was higher in patients of the high-pressure group,
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pressure patients, we used a pressure within the low-pressure

whereas all other data were not significantly different be-
tween the groups. Table 3 shows the procedural data. On range and in 4.5% of low-pressure patients, a pressure within
average, there was a difference of '6 atm in the actual the high-pressure range.
balloon pressure used, and the distribution of this parameter
in either group is displayed in Figure 1. In 45 patients of the Early 30-Day Outcome
low-pressure group (14 with calcified lesions), the operator There were no cases of coronary artery perforation in either
group. Table 4 indicates the number of patients with unto-
ward events within the first 30 days after the procedure and
TABLE 3. Procedural Data
the respective relative risk associated with high-pressure
High Pressure Low Pressure inflation. During this period, there was a higher incidence of
(n5468) (n5466) non–Q-wave myocardial infarction (CK or CK-MB elevation
Maximal balloon pressure, atm 16.962.0* 11.162.1 .3 times normal) in the group of high balloon pressure,
Balloon-to-vessel ratio 1.0960.10 1.0860.09 6.4%, versus 3.4% in the low-pressure group; relative risk
Number of implanted stents 1.661.0 1.661.1 1.87; 95% CI 1.02 to 3.42. Figure 2 shows the incidence of
Stent type myocardial infarction defined according to the criteria ap-
Inflow 25.9 27.7 plied in the EPISTENT trial.8
NIR 20.7 21.9
Palmaz-Schatz 20.5 18.5 TABLE 4. Adverse Events Recorded During the Early 30 Days
Pura-A 19.0 19.5 High Pressure Low Pressure Relative Risk
Multi-Link 13.9 12.4 (n5468) (n5466) [95% CI]
Residual dissection after stenting 2.4 2.6 Stent occlusion 8 (1.7) 9 (1.9) 0.89 [0.30–2.56]
Administration of abciximab 10.3 9.2 Death 2 (0.4) 4 (0.9) 0.50 [0.05–3.46]
Final diameter stenosis, % 5.468.4* 6.967.0 Nonfatal Q-wave 4 (0.9) 2 (0.4) 2.00 [0.29–21.93]
Acute elastic recoil, mm 0.3660.21 0.3760.19 myocardial infarction

Acute lumen gain, mm 2.1260.56* 1.9760.52 CABG 1 (0.2) 1 (0.2) 1.00 [0.01–78.00]

Procedural success 98.3 98.9 Repeat PTCA 9 (1.9) 11 (2.4) 0.81 [0.30–2.14]

Data are mean6SD or percentages. Any clinical event 13 (2.8) 14 (3.0) 0.92 [0.40–2.10]
*P,0.05 vs low-pressure group. Data are number of patients (%).
 Dirschinger et al High- vs Low-Pressure Coronary Stenting 921

TABLE 6. Results of the 1-Year Survival Analysis

High Low Hazard
Pressure Pressure Ratio*
(n5468) (n5466) [95% CI]
Overall survival 96.2 94.8 0.74 [0.40–1.37]
Survival free of Q-wave 94.9 93.8 0.82 [0.48–1.41]
myocardial infarction
Survival free of Q-wave myocardial 78.8 75.5 0.85 [0.65–1.11]
infarction and target lesion
revascularization
Figure 2. Bar graph presenting, for both study groups, 30-day Data are percentages.
incidence of myocardial infarction (MI) defined according to cri- *Hazard ratio indicates the risk for an adverse outcome associated with
teria used in EPISTENT trial.8 high-pressure inflation.

Angiographic Follow-Up and 1-Year Discussion

Clinical Outcome
Patients without adverse events within the first 30 days after
the procedure were considered eligible for a 6-month angio-
graphic control. It was carried out in 372 (83.0%) of the
eligible patients in the high-pressure group and 370 (82.2%)
of the eligible patients in the low-pressure group.
The results of the quantitative assessment of the follow-up
angiogram are presented in Table 5. The incidence of reste-
nosis was 30.4% in the high-pressure group and 31.4% in the
low-pressure group, and the relative risk associated with
high-pressure inflation was 0.97 (95% CI 0.75 to 1.26).
As shown in Table 6, our primary end point, event-free
survival, was not significantly different between the 2 groups,
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This randomized study compared 2 strategies of balloon
dilatation pressure during stent placement in native coronary
vessels of 934 patients with coronary artery disease. It
showed that systematic use of high pressure is not associated
with any appreciable reduction in the incidence of stent
thrombosis and restenosis. Most importantly, the rate of
adverse clinical events during the 1 year after the intervention
was comparable for both treatment strategies.
High Balloon Pressure and Early Adverse Events
The overall incidence of stent thrombosis within the first 30
days after the procedure was 1.8% in the present study. This
is in the range of stent thrombosis rate reported for patients
treated with combined antiplatelet agents after stenting.4,5,15,16

with 78.8% in patients assigned to high-pressure dilatation We could not show any significant difference in the incidence
and 75.5% in patients assigned to low-pressure dilatation, of this complication between high- and low-pressure infla-
with a hazard ratio of 0.85 (0.65 to 1.11). Repeat PTCA was tion, but we should also take into account that this study was
required in 77 patients (16.4%) of the high-pressure arm, not sufficiently powered for the analysis of the secondary end
compared with 78 patients (16.7%) in the low-pressure arm; point of stent thrombosis. Earlier observational studies re-
relative risk of 0.98 (0.72 to 1.35). Primary end-point analysis ported a low incidence of stent thrombosis with high-pressure
performed in different subgroups defined by the stent model inflation and dual antiplatelet therapy with ticlopidine plus
used, the presence of complex or calcified lesions, or lesions aspirin.5,16 More recently, 2 randomized trials demonstrated
located in small vessels did not show any significant influ- the independent preventive effect of ticlopidine plus aspirin
ence of high-pressure dilatation (Table 7). against stent thrombosis.9,10 This therapy was particularly
Table 8 shows the main findings in subgroups defined by beneficial in patients with high risk for stent thrombosis.17
the random assignment and actual pressure used. For both
study groups, the results achieved in patients in whom a TABLE 7. Risk for an Adverse 1-Year Outcome (Death,
Q-Wave Myocardial Infarction or Target Vessel
pressure outside the assigned range was applied were not Revascularization) Associated With High-Pressure Inflation in
significantly different from those achieved in patients in Different Subgroups
whom a pressure within the limits specified by the protocol
Hazard Ratio
was used.
[95% CI]
Patients with Inflow stent 0.89 [0.55–1.42]
TABLE 5. Results of the 6-Month Angiographic Follow-Up
Patients with Multi-Link stent 1.16 [0.37–3.69]
High Pressure Low Pressure Relative Risk Patients with NIR stent 1.00 [0.60–1.65]
(n5372) (n5370) [95% CI]
Patients with Plamaz-Schatz stent 0.84 [0.42–1.67]
Diameter stenosis, % 41.4625.8 43.5628.1 zzz Patients with Pura-A stent 0.70 [0.36–1.34]
Late lumen loss, mm 1.1360.79 1.1060.79 zzz Patients with ACC/AHA type B2/C lesions 0.79 [0.57–1.09]
Loss index 0.5560.39 0.5960.47 zzz Patients with calcified lesions 1.25 [0.65–2.40]
Incidence of restenosis 30.4 31.4 0.97 [0.75–1.26]
Patients with stents in vessels 0.78 [0.52–1.15]
Stenoses 26.6 25.5 1.05 [0.79–1.39] #2.8 mm
Total occlusions 3.8 5.9 0.63 [0.32–1.24] ACC/AHA indicates American College of Cardiology/American Heart
Data are mean6SD or percentages. Association.
 922 Circulation August 31, 1999
TABLE 8. Main Findings in Subgroups Defined by the Random Assignment and Actual
Pressure Used
High Pressure
(n5468)
Actual Pressure
15–20 atm
(n5420)
Actual balloon pressure, atm 17.461.3
Stent occlusion 1.7
Incidence of restenosis 30.8
Survival free of myocardial 78.8
infarction and target lesion
revascularization
Data are mean6SD or percentages.
The rates of early clinical events such as death, Q-wave
myocardial infarction, and reintervention were also compa-
rable between the 2 groups with different pressure inflation
strategies. Another important finding of this study is the
higher incidence of CK elevation after stenting with high-
pressure inflation, which may be of concern considering the
most recent data about its clinical significance.18 Our results,
however, should not be interpreted as contradicting a positive
role conceived for optimal stent expansion. Bermejo et al19
recently demonstrated with intravascular ultrasound investi-
gation that despite high-pressure deployment, lumen dimen-
sions after stenting are only 57% of the maximum achievable
because of inadequate balloon expansion and elastic recoil.
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These issues were not the focus of the present study, and it
remains to be demonstrated which is the best strategy to
achieve an optimal stent expansion.
High Balloon Pressure and Restenosis
Final lumen achieved after stenting is one of the most
powerful predictors of restenosis at follow-up.20 High-
pressure inflation is expected to afford a better lumen at the
end of the intervention. In fact, a slight yet significant
difference in residual stenosis was verified in the present
study in favor of the high-pressure strategy. Conversely, the
use of high balloon pressure may engender concerns about a
potential exacerbation of the hyperplastic response from the
injured vessel wall. The present randomized trial demon-
strated that restenosis after coronary stent placement is not a
function of the balloon pressure strategy used. All angio-
graphic and clinical indexes of restenosis were comparable
between the high- and low-pressure arms. Conversely, our
findings did not justify the concerns that this approach may
serve as a stimulus for excessive neointimal hyperplasia after
stenting.
Limitations of the Study
Studies that assess the role of various pressure inflation
strategies during coronary stent placement suffer from the
lack of a clear-cut definition of high pressure. The pressure
used in the high-pressure arm of the present study complies
well with the values applied by the team that proposed this
strategy for the first time4,5 and also corresponds to the recent
recommendations of the American College of Cardiology
Low Pressure
(n5466)
Actual Pressure Actual Pressure Actual Pressure
,15 atm 8 –13 atm .13 atm
(n548) (n5421) (n545)
12.561.7 10.661.5 15.361.9
2.1 1.9 2.2
26.5 31.9 26.3
79.2 75.1 79.9
Expert Consensus Document.6 Similarly, there is no clear
definition of low pressure. In their initial experience, Schatz
et al used pressure ranges of 6 to 10 atm21 or 9 to 12 atm.22
Our average inflation pressure of 11.1 atm in the low-pressure
group is also comparable to that of 1068 atm used in the
BENESTENT trial1 before the advent of high-pressure
strategy.
Even with minimally compliant balloons, balloon size and
consequently balloon-to-vessel ratio are not completely inde-
pendent from the inflation pressure. If both pressure and
balloon-to-vessel ratio vary concomitantly, it may be difficult
to estimate the independent role of inflation pressure. The
results presented here should not be extrapolated to proce-
dures in which the combination of high-pressure inflation
with compliant balloons may significantly increase the
balloon-to-vessel ratio. Our primary goal was to keep a
comparable balloon-to-vessel ratio between the 2 groups and
to test the independent role of inflation pressure. Appropri-
ately designed studies are required to evaluate which is the
best balloon-to-vessel ratio to be used during coronary stent
deployment to achieve an optimal result.
Another limitation of the study is that not all patients have
been treated with an inflation pressure within the assigned
range. However, the deviation from the predefined range was
mostly minimal, and only 6.0% of the high-pressure patients
and 4.5% of low-pressure patients crossed over to the
opposite inflation pressure range. These data also indicate
that a unique inflation pressure strategy may not be applied
for all kinds of lesions.
Conclusions
The systematic use of high-pressure inflation during coronary
stent placement is not associated with any significant influ-
ence on the 1-year outcome of patients undergoing this
intervention. Depending on lesion characteristics, the opera-
tor may take advantage of a wider range of balloon inflation
pressures that may be used to achieve optimal results.
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