A Randomized Trial Comparing Stenting With Balloon

Angioplasty in Small Vessels in Patients With Symptomatic

Coronary Artery Disease
Adnan Kastrati, MD; Albert Schömig, MD; Josef Dirschinger, MD; Julinda Mehilli, MD;
Franz Dotzer, MD; Nicola von Welser, MD; Franz-Josef Neumann, MD;
for the ISAR-SMART Study Investigators*

Background—More than 30% of the lesions currently treated with interventional approaches are situated in vessels smaller
in size than those representing an established indication for stenting. The objective of this randomized trial was to assess
whether compared with PTCA, stenting of small coronary vessels is associated with a reduction of restenosis.
Methods and Results—Patients with symptomatic coronary artery disease with lesions situated in native coronary vessels
between 2 and 2.8 mm in size were randomly assigned to be treated with either stenting (n⫽204) or PTCA (n⫽200).
Adjunct therapy consisted of abciximab, ticlopidine, and aspirin. Repeat angiography at 6-month follow-up was
performed in 83% of the patients. The primary end point of the study was the incidence of angiographic restenosis
(ⱖ50% diameter stenosis) at follow-up; adverse clinical events, such as death, myocardial infarction, stroke, or target
vessel revascularization, were assessed as secondary end points. After 7 months, there were no significant differences
in the infarct-free survival rates between the 2 study groups: 96.6% for stent patients, and 97.0% for PTCA patients
(P⫽0.80). Target vessel revascularization was needed in 20.1% of the stent patients and 16.5% of the PTCA patients
(P⫽0.35). The primary end point of angiographic restenosis was found in 35.7% of the stent patients and 37.4% of the
PTCA patients (P⫽0.74). The net lumen gain observed at follow-up was identical (0.76⫾0.78 in the stent group versus
0.76⫾0.63 mm in the PTCA group, P⫽0.93).
Conclusions—Stenting and PTCA are associated with equally favorable results when used for treating lesions in small
coronary vessels. (Circulation. 2000;102:2593-2598.)
Key Words: stents 䡲 angioplasty 䡲 restenosis
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more cost-effective in the long term than PTCA.12,13 A

V essel size is inversely correlated with the risk of reste-
nosis and adverse outcome after percutaneous coronary
interventions.1–3 This is because a smaller vessel is more
limited in the ability to accommodate lumen renarrowing,
which invariably occurs to some degree in most vessels after
balloon dilatation.4,5 Interventions in small coronary vessels
(⬍2.8 to 3.0 mm) constitute a considerable proportion (30%
to 50%)1–3,6 – 8 of the ⬎1 million coronary catheter-based
procedures performed worldwide each year. PTCA and stent-
ing are the 2 most frequently used interventions in patients
with coronary artery disease.9 Large coronary vessels repre-
sent an established indication for stenting because of its
superiority compared with PTCA, as shown in several ran-
domized clinical trials.10 –12 On this basis, the Food and Drug
Administration approved the Palmaz-Schatz stent for use in
large coronary arteries (ⱖ3 mm). Stenting is associated with
increased procedural costs9; however, the improved outcome,
with a reduction in the need for reinterventions, achieved
when large vessels are stented has rendered this technique
retrospective analysis has shown that stenting might also be
superior to PTCA in small coronary vessels.14 Nevertheless,
because of the absence of appropriately designed randomized
studies, there are no well-defined recommendations15 regard-
ing the intervention of choice for coronary vessels smaller
than those included in the clinical stent trials referred to
above. This is currently perceived as a limitation in interven-
tional cardiology.16
Consequently, the objective of this randomized trial was to
assess whether stenting of small coronary vessels in patients
with symptomatic coronary artery disease, compared with
PTCA, is associated with a reduction of restenosis.
Methods
Patients
Patients were considered eligible for randomization if they com-
plained of angina pectoris or had exercise-induced ischemia in the
presence of angiographically significant lesions (ⱖ70% diameter

Received May 17, 2000; revision received July 6, 2000; accepted July 7, 2000.
*The centers and investigators participating in the Intracoronary Stenting or Angioplasty for Restenosis Reduction in Small Arteries (ISAR-SMART)
Study are listed in the Appendix.
Correspondence to Dr Adnan Kastrati, Deutsches Herzzentrum, Lazarettstr. 36, 80636 München, Germany. E-mail kastrati@dhm.mhn.de
© 2000 American Heart Association, Inc.
Circulation is available at http://www.circulationaha.org

2593
 2594 Circulation November 21, 2000

stenosis) in a native coronary vessel between 2.0 and 2.8 mm in size TABLE 1. Patients’ Clinical Characteristics
(online measurement after intracoronary injection of nitroglycerin),
provided that they had given written informed consent for participa- Stent PTCA
tion in the study. Intervention in the setting of acute myocardial (n⫽204) (n⫽200) P
infarction (within the last 72 hours before the intervention), lesions Age, y 65.0⫾11.3 66.5⫾11.0 0.18
situated in the left main coronary artery, lesions produced by in-stent
Women, % 22.5 24.0 0.73
restenosis, and contraindications to the antithrombotic medication
used in the present study (see below) served as exclusion criteria. On Diabetes, % 25.0 24.5 0.91
the basis of the above criteria, the patients were randomly assigned Current smoker, % 22.5 16.5 0.13
to receive either stenting or PTCA. Immediately after successful
Cholesterol level, mg/dL 210⫾48 205⫾46 0.30
passage of the guidewire through the index stenosis, randomization
was performed by using sealed envelopes containing the randomiza- Blood pressure, mm Hg
tion sequence generated by computer before the initiation of the trial. Systolic 147⫾26 147⫾27 0.99
The present study was conducted according to the principles of the
Diastolic 72⫾12 71⫾14 0.51
Declaration of Helsinki and was approved by the ethics committees
of the participating institutions. Unstable angina, % 42.6 36.5 0.21
Previous myocardial infarction, % 34.8 39.0 0.38
Procedures and Antithrombotic Treatment Previous CABG, % 10.3 15.0 0.15
During the intervention, patients received intravenous heparin (7500
U) and aspirin (500 mg) as well as a bolus of abciximab (0.25 mg/kg Postdischarge therapy, %
body wt), followed by continuous infusion (0.125 ␮g/kg per minute ␤-blockers 94.6 94.5 0.96
for 12 hours). All patients received a combination of oral therapy ACE inhibitors 78.4 83.0 0.30
with 250 mg ticlopidine plus 100 mg aspirin twice daily for 4 weeks
after stenting or 2 weeks after plain PTCA; aspirin was taken Statins 87.3 85.5 0.61
indefinitely. Nitrates 13.7 17.0 0.36
Stent placement and balloon angioplasty procedures were per- Calcium antagonists 3.4 3.5 0.97
formed according to standard methods. The study protocol recom-
mended the achievement of a final diameter stenosis of ⬍30% and Values are mean⫾SD or percentages.
Thrombolysis in Myocardial Infarction (TIMI) flow grade 3 at the
end of procedures; it allowed the implantation of a stent(s) in patients at 30 days (phone interview in 100% of the patients) and 7 months
allocated to PTCA if there were large dissections (⬎5 mm) or TIMI (clinical visit in 90% and phone interview in 10% of the patients).
flow grade ⬍3 on the angiogram. The premounted MULTI-LINK
stent on ⱖ2.5 mm balloons (Guidant, Advanced Cardiovascular Statistical Analysis
Systems, Inc.) was the recommended stent type in this trial. The number of patients included in the present study was based on
the sample size estimation for our primary end point of angiographic
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Angiographic Evaluation
Lesions were classified by using the modified American College of
Cardiology/American Heart Association grading system.17 Digital
angiograms were analyzed offline with the automated edge detection
system CMS (Medis Medical Imaging Systems) in the Angiographic
Core Laboratory. Matched views were selected for angiograms
recorded before and immediately after the intervention and at
follow-up. Each angiographic sequence was preceded by an intracor-
onary injection of nitroglycerin. The parameters obtained were
minimal lumen diameter (MLD), reference diameter, diameter of the
stenosis, and diameter of the maximally inflated balloon during the
index 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 noted
between measurements after the procedure and at follow-up. Loss
index was calculated by dividing late lumen loss by acute lumen
gain. Net lumen gain was defined as the difference between MLD at
follow-up and MLD before balloon dilatation.
Definitions and End Points of the Study
The primary end point of the present study was angiographic
restenosis at follow-up (defined as diameter stenosis ⱖ50%). The
secondary end points of the study were the adverse clinical events,
such as all-cause death, myocardial infarction, stroke, and target
vessel revascularization (PTCA or CABG). The diagnosis of acute
myocardial infarction was based on the presence of new pathological
Q waves or a value of creatine kinase or its MB isoenzyme at least
3 times the upper limit.18 Creatine kinase was determined before and
immediately after the procedure, every 8 hours for the first 24 hours
after the procedure, and daily afterward until discharge. A diagnosis
of stroke required confirmation by CT or MRI of the head. Target
vessel revascularization was performed in the presence of angio-
graphic restenosis and symptoms or signs of ischemia. Cardiac
events were monitored throughout the follow-up period and analyzed
restenosis. On the basis of previous observations for the vessel size
range treated in the present study, we assumed a restenosis rate of
38.6% after stenting2 and 55% after PTCA.14 The assumed 30%
reduction of restenosis for stenting is comparable to that verified in
previous randomized trials for larger coronary vessels.10,11 For a
power of 80% to detect this difference at a 2-sided ␣ level of 0.05,
200 patients in each group were needed if a follow-up angiography
rate of at least 75% was assumed.
The main analysis was performed on an intention-to-treat basis,
and the results are expressed as mean⫾SD or proportions (%). The
differences between groups were assessed by the ␹2 test or Fisher
exact test for categorical data and by t test or Wilcoxon test for
continuous data. The homogeneity of the treatment effect across
strata was assessed by the test of Breslow and Day.19 Survival
analysis was made by the Kaplan-Meier method, and differences in
survival parameters were assessed by the log-rank test. Statistical
significance was accepted for 2-sided value of P⬍0.05.
Results
We enrolled 404 patients in this trial: 204 were assigned to
stenting, and 200 were assigned to PTCA. Table 1 shows the
clinical characteristics of the patients. The groups were well
matched with respect to these characteristics. Table 2 shows
the baseline angiographic characteristics of the patients, with
only a trend for PTCA patients to have a smaller vessel size
and MLD as well as a tighter diameter stenosis before the
procedure. Procedural data are displayed in Table 3. Among
patients allocated to the stent treatment arm, 4.4% received
only plain PTCA because of an inability to place the
prosthesis. On the other hand, in 16.5% of the patients
assigned to PTCA treatment, the placement of at least 1 stent
was necessary. The stented segment length in the stent group
 Kastrati et al Stenting vs PTCA in Small Coronary Vessels 2595

TABLE 2. Baseline Angiographic Data

Stent (n⫽204) PTCA (n⫽200) P
LV ejection fraction,* % 61.3⫾13.6 59.8⫾15.4 0.31
Number of diseased vessels, % 0.47
Single-vessel disease 19.6 21.0
2-vessel disease 36.3 30.5
3-vessel disease 44.1 48.5
Vessel, % 0.83
LAD 42.2 39.5
LCx 37.7 40.5
RCA 20.1 20.0
Complex lesions,† % 75.0 76.0 0.81
Total occlusions, % 6.9 7.0 0.96
Restenotic lesions, % 4.4 3.5 0.64
Lesion length, mm 12.5⫾6.9 11.8⫾7.1 0.30
Vessel size, mm 2.41⫾0.25 2.37⫾0.27 0.13
2.43 (2.27, 2.58)† 2.41 (2.18, 2.54)‡
Minimal lumen diameter, mm 0.59⫾0.38 0.51⫾0.33 0.08
DS before the procedure, % 75.8⫾16.1 78.0⫾14.4 0.14
Values are mean⫾SD or percentages.
LV indicates left ventricular; LAD, left anterior descending coronary artery; LCx, left circumflex
coronary artery; RCA, right coronary artery; and DS, diameter stenosis.
*Available in 394 patients.
†Complex lesions were defined as lesions of type B2 or C according to the modified American
College of Cardiology/American Heart Association classification.17
‡Median (25th, 75th percentiles).

was 20.8⫾10.9 mm; in only 6.4% of the stent patients did the died (P⫽0.73). Figure 1 displays the almost identical curves
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operator chose to use a hand-mounted stent on a 2.0-mm
balloon. The procedure was completed with a significantly
better acute result in the stent group.
Clinical Outcome
Clinical follow-up was complete for all patients. The adverse
events observed after 30 days are shown in Table 4. No cases
of stroke were recorded, and overall, the incidence of adverse
events was low and comparable in both groups. In addition,
bleeding complications requiring blood transfusion occurred
in 4 stent patients and 2 PTCA patients (P⫽0.70).
During the 7-month follow-up period, 2 patients in the
stent group (1.0%) and 3 patients in the PTCA group (1.5%)
of infarct-free survival: 96.6% of the patients randomly
assigned to stenting and 97.0% of the patients randomly
assigned to PTCA survived without myocardial infarction
(P⫽0.80). Also, there were no significant differences regard-
ing the reintervention rates: 7 stent patients (3.4%) and 5
PTCA patients (2.5%) needed bypass surgery (P⫽0.58), and
34 stent patients (16.7%) and 28 PTCA patients (14.0%)
required repeat balloon angioplasty (P⫽0.46). Thus, the
incidence of target vessel revascularization (either CABG or
repeat PTCA) was 20.1% among stent and 16.5% among
PTCA patients (P⫽0.35, Figure 2). At the end of the
follow-up period, 77% of the stent patients and 81% of the
PTCA patients survived without an adverse event (P⫽0.22).

TABLE 3. Procedural Data

Stent (n⫽204) PTCA (n⫽200) P
Multilesion intervention, % 34.3 33.5 0.86
Receiving assigned treatment, % 95.6 83.5 ⬍0.001
Maximal balloon pressure, atm 13.5⫾3.3 12.0⫾3.5 ⬍0.001
Balloon-to-vessel ratio 1.13⫾0.12 1.06⫾0.12 ⬍0.001
Final minimal lumen 2.35⫾0.40 1.98⫾0.41 ⬍0.001
diameter, mm
Final diameter stenosis, % 7.0⫾13.0 18.8⫾12.9 ⬍0.001
Acute lumen gain, mm 1.77⫾0.50 1.47⫾0.51 ⬍0.001
Total radiation exposure time, min 12.8 (7.7, 20.0) 10.7 (7.4, 16.4) 0.07
Values are mean⫾SD except for radiation exposure time, shown as median (25th, 75th
percentiles).
 2596 Circulation November 21, 2000

TABLE 4. Adverse Events During the First 30 Days

Stent PTCA
(n⫽204) (n⫽200) P
Death, n (%) 1 (0.5) 1 (0.5) 0.67
Nonfatal myocardial infarction, n (%) 4 (2.0) 2 (1.0) 0.70
Q wave 1 (0.5) 0 0.99
Non–Q wave 3 (1.5) 2 (1.0) 0.98
CABG, n (%) 1 (0.5) 1 (0.5) 0.67
Figure 2. Bar graphs comparing indexes of restenosis defined
Repeat PTCA, n (%) 1 (0.5) 0 0.99 as diameter stenosis ⱖ50% (left pair of bars), diameter stenosis
Any of above events, n (%) 6 (2.9) 3 (1.5) 0.52 ⱖ70% (middle pair of bars), and target vessel revascularization
(TVR, right pair of bars) at follow-up.
Values are number of patients (%).
and ⬎2.5 mm), the restenosis rates in the stent and PTCA
Angiographic Results arms were 38.9% versus 37.7%, 30.2% versus 33.3%, and
Repeat angiography at follow-up was performed in 334 36.5% versus 40.7% in the first, second, and third tertile,
patients (or 83% of the entire study population) in a compa- respectively. The homogeneity test yielded a value of
rable proportion between stent (83.8%) and PTCA (81.5%) P⫽0.90, showing no significant difference in treatment effect
patients (P⫽0.54). Our primary end point of restenosis associated with vessel size. Finally, when the analysis was
according to the conventional definition of ⱖ50% diameter confined to procedures for which a nominal balloon size of
stenosis was encountered in 35.7% of the patients assigned to ⱖ2.5 mm was chosen, the restenosis rate was 34.8% in the
stenting and 37.4% of the patients assigned to PTCA stent arm and 37.6% in the PTCA arm (P⫽0.63).
(P⫽0.74, Figure 2). Also, there was no significant difference
with respect to more severe restenosis (ⱖ70% diameter Discussion
stenosis), with 22.2% among stent patients and 18.4% among Percutaneous interventions in small coronary vessels are
PTCA patients (P⫽0.39, Figure 2). Table 5 summarizes the usually associated with an increased risk of restenosis.20 This
follow-up angiographic data. As expected, compared with represents an important limitation in the treatment of coro-
PTCA, stenting was associated with a higher late lumen loss. nary artery disease because of the frequency with which
Other quantitative indexes of restenosis, such as MLD and interventions involve small coronary arteries. Stenting has
diameter stenosis, were comparable between the 2 random- been the first successful intervention for the reduction of
restenosis10,11 since the introduction of PTCA. Using angio-
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ization arms. Despite a much better acute gain achieved in the

stent arm, net gain at follow-up was identical in the 2 groups, graphic restenosis as a primary end point and assessing the
as graphically displayed in Figure 3. clinical results after 7 to 8 months after the intervention, 2
We performed additional analyses beyond the main anal- landmark trials unequivocally demonstrated the advantages
ysis on the basis of the intention-to-treat principle. No of stenting over PTCA for large coronary vessels ⱖ3 mm.10,11
significant differences were seen when the restenosis analysis It is conceivable to expect even a major impact of stenting in
was performed on an as-treated basis, ie, when patients who subsets with a higher likelihood of restenosis, such as small
actually received stenting were compared with those who coronary arteries. We also chose angiographic restenosis as
actually received PTCA irrespective of the randomization. the primary end point of the present study and were able to
The restenosis rate was 36.5% for those patients actually perform an angiographic restudy at follow-up in 83% of the
treated with stenting versus 36.6% for those treated with plain patients.
PTCA. Patients with single-lesion interventions had a reste- In the present trial, small coronary arteries were defined as
nosis rate of 36.2% in the stent arm and 36.8% in the PTCA vessels ⱕ2.8 mm in size according to online digital measure-
arm (P⫽0.93). When the patients were subdivided in 3
groups (tertiles) according to vessel size (⬍2.3, 2.3 to 2.5, TABLE 5. Results of 6-mo Angiographic Follow-Up
Stent PTCA
(n⫽171) (n⫽163) P
Minimal lumen 1.35⫾0.73 1.28⫾0.62 0.34
diameter, mm
Diameter stenosis, % 42.2⫾30.6 45.3⫾26.5 0.32
Late lumen loss, mm 1.04⫾0.73 0.72⫾0.71 ⬍0.001
Loss index 0.59⫾0.44 0.44⫾0.57 0.006
Net gain, mm 0.76⫾0.78 0.76⫾0.63 0.93
Incidence of restenosis 35.7 37.4 0.74
(DS ⱖ50%), %
Incidence of restenosis 22.2 18.4 0.39
(DS ⱖ70%), %
Figure 1. Kaplan-Meier curves showing survival free of myocar-
dial infarction (MI) in both study groups. Values are mean⫾SD or percentages.
 Kastrati et al
Figure 3. Cumulative curves showing greater acute lumen gain
achieved with stenting and identical net lumen gain measured at
follow-up.
ment. We aimed at creating a clear distinction from the vessel
size that characterized previous randomized trials, which
focused on lesions in large coronary arteries.10,11 In fact, mean
vessel size was ⬇3.0 mm in studies of Serruys et al10 and
Fischman et al,11 suggesting the inclusion of a considerable
number of vessels that were below the limit defined by their
study protocols. This is perhaps an inevitable consequence of
differences between visual estimates or online measurements
and quantitative evaluation based on automatic contour de-
tection techniques. With an average vessel size of 2.4 mm, the
present trial provides implications for a population that is
clearly distinct from the populations of previous clinical trials
comparing stenting with PTCA.10,11
In the present trial, we chose to use the MULTI-LINK
stent. Although there is abundant experimental evidence
about differences in stent performance, it has been difficult
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for clinicians to observe a relevant impact of stent type on
clinical outcome.21 In a randomized clinical trial comparing 5
stent designs, including the classic Palmaz-Schatz stent, the
MULTI-LINK stent was associated with the most favorable
outcome.22
Small vessel size negatively affects both early23 and late2
outcome of patients undergoing coronary interventions. Gly-
coprotein IIb/IIIa inhibition with abciximab has significantly
reduced the incidence of adverse events,18 especially in
high-risk subsets. The 30-day incidence of ischemic events
in the present trial was low (2.9% in the stent group and 1.5%
in the PTCA group) and compares favorably with early event
rates reported previously for this category of vessel size after
either PTCA8,14 or stenting.2,3,14 This is probably the result of
the routine use of abciximab in the present trial. It should be
pointed out that as in previous trials comparing these 2
approaches, a direct comparison between stenting and PTCA
with respect to the early ischemic events is hindered by the
provisional use of stents in 16.5% of PTCA patients who
were considered at a higher risk for early complications.
We also found no significant difference in adverse event
rates during the entire follow-up period, with 23% in the stent
group and 19% in the PTCA group. These data seem to
compare favorably with previously published findings from
nonrandomized studies, although the comparison is difficult
because of differences in adjunct antithrombotic therapy. Past
retrospective large-scale reports with stenting in small coro-
nary vessels have shown adverse event rates of 30%2 to 37%.3
Stenting vs PTCA in Small Coronary Vessels 2597
Savage et al14 found an event rate of 22% among 163 patients
who received stenting in vessels with an average diameter of
2.7 mm and who were selected for a subgroup analysis from
a prior randomized trial.11 Fewer data are available about
restenosis-driven clinical events in patients undergoing
PTCA in small coronary arteries. Among 168 patients with
small-vessel lesions treated with PTCA, the adverse event
rate was 33%.14 The reason for the difference with the results
achieved in our group with PTCA probably resides not only
in the different antithrombotic therapy but also in the differ-
ent acute results immediately after the procedure: residual
diameter stenosis was only 19% in the PTCA arm of the
present trial, which was markedly lower than that of 34% in
the report mentioned above.14 This also indicates that the
availability of stents may currently allow a more aggressive
dilation strategy during PTCA.
The lack of significant differences in our primary end
point, restenosis, explains the similarity in clinical results
achieved with stenting and PTCA in the present trial. Despite
a much greater acute lumen gain obtained with stenting, it
was offset by an excess in lumen loss occurring during
follow-up, and the net gain result was strikingly similar in
both groups. These findings as well as the differences in loss
index suggest that “the bigger, the better” may not be a valid
criterion for comparing stenting with PTCA for lesions in
small coronary arteries. The acute gain achievable with
stenting is limited by the smaller vessel size, and this seems
to reduce the accommodation potential for subsequent neo-
intimal hyperplasia. The present restenosis findings for both
stent and PTCA reveal our limited ability to mechanically
attenuate the excess risk connected with smaller vessel size
and underscore the need of rendering smaller coronary
vessels a specific target of antirestenotic approaches.
In conclusion, stenting and PTCA with optimized anti-
platelet therapy are associated with equally favorable results
when used for treating lesions in small coronary vessels.
Therefore, for lesions in small coronary arteries, no additional
benefit in outcome is provided by systematic stenting com-
pared with a strategy based on plain PTCA and provisional
stenting in ⬍20% of the cases.
Appendix
The following centers and investigators participated in the Intracor-
onary Stenting or Angioplasty for Restenosis Reduction in Small
Arteries (ISAR-SMART) Study:
Steering Committee
A. Schömig (chairman), A. Kastrati, J. Dirschinger, and
F.-J. Neumann.
Data Coordinating Center
A. Kastrati, M. Hadamitzky, and H. Kreuzberg, Deutsches Herzzen-
trum, Munich.
Angiographic Core Laboratory
J. Mehilli, A. Redl, and D. Kiemoser, Deutsches Herzzentrum,
Munich.
Clinical Follow-Up Center
N. von Welser, D. Hall, H. Holle, K. Hösl, and W. Krämer,
Deutsches Herzzentrum, Munich.
 2598 Circulation November 21, 2000
Clinical Centers
Deutsches Herzzentrum, Munich: J. Dirschinger (principal investi-
gator), R. Blasini, C. Schmitt, and M. Gawaz; 1. Medizinische Klinik
rechts der Isar, Munich: F.-J. Neumann (principal investigator), E.
Alt, M. Seyfarth, and H. Schühlen; Medizinische Klinik I, Garmisch-
Partenkirchen: F. Dotzer (principal investigator) and M.
Fleckenstein.
Acknowledgments
This trial was supported by grants from the Technische Universität
München, Munich; Lilly Deutschland GmbH, Bad Homburg; and
Guidant GmbH & Co, Isernhagen, Germany. We highly appreciate
the invaluable contribution of the medical and technical staffs
operating in the catheterization laboratories and wards of the
participating institutions.
References
1. Foley DP, Melkert R, Serruys PW. Influence of coronary vessel size on
renarrowing process and late angiographic outcome after successful
balloon angioplasty. Circulation. 1994;90:1239 –1251.
2. Elezi S, Kastrati A, Neumann FJ, et al. Vessel size and long-term
outcome after coronary stent placement. Circulation. 1998;98:
1875–1880.
3. Akiyama T, Moussa I, Reimers B, et al. Angiographic and clinical
outcome following coronary stenting of small vessels: a comparison with
coronary stenting of large vessels. J Am Coll Cardiol. 1998;32:
1610 –1618.
4. Lehmann KG, Melkert R, Serruys PW. Contributions of frequency dis-
tribution analysis to the understanding of coronary restenosis: a reap-
praisal of the gaussian curve. Circulation. 1996;93:1123–1132.
5. Schömig A, Kastrati A, Elezi S, et al. Bimodal distribution of angio-
graphic measures of restenosis six months after coronary stent placement.
Circulation. 1997;96:3880 –3887.
6. Hirshfeld JW, Jr, Schwartz JS, Jugo R, et al. Restenosis after coronary
angioplasty: a multivariate statistical model to relate lesion and procedure
variables to restenosis. J Am Coll Cardiol. 1991;18:647– 656.
7. Bourassa MG, Lespérance J, Eastwood C, et al. Clinical, physiologic,
Downloaded from http://ahajournals.org by on June 18, 2020
anatomic and procedural factors predictive of restenosis after percutaneous
transluminal coronary angioplasty. J Am Coll Cardiol. 1991;18:368–376.
8. Schunkert H, Harrell L, Palacios IF. Implications of small reference
vessel diameter in patients undergoing percutaneous coronary revascu-
larization. J Am Coll Cardiol. 1999;34:40 – 48.
9. Topol EJ. Coronary-artery stents: gauging, gorging, and gouging. N Engl
J Med. 1998;339:1702–1704.
10. 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.
11. 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.
12. Serruys PW, van Hout B, Bonnier H, et al. Randomised comparison of
implantation of heparin-coated stents with balloon angioplasty in selected
patients with coronary artery disease (Benestent II). Lancet. 1998;352:
673– 681.
13. Peterson ED, Cowper PA, DeLong ER, et al. Acute and long-term cost
implications of coronary stenting. J Am Coll Cardiol. 1999;33:
1610 –1618.
14. Savage MP, Fischman DL, Rake R, et al. Efficacy of coronary stenting
versus balloon angioplasty in small coronary arteries: Stent Restenosis
Study (STRESS) Investigators J Am Coll Cardiol. 1998;31:307–311.
15. Holmes DR Jr, Hirshfeld J Jr, Faxon D, et al. ACC Expert Consensus
document on coronary artery stents: document of the American College
of Cardiology J Am Coll Cardiol. 1998;32:1471–1482.
16. Topol EJ, Serruys PW. Frontiers in interventional cardiology. Circu-
lation. 1998;98:1802–1820.
17. Ellis SG, Vandormael MG, Cowley MJ, et al. Coronary morphologic and
clinical determinants of procedural outcome with angioplasty for mul-
tivessel coronary disease: implications for patient selection. Circulation.
1990;82:1193–1202.
18. Topol EJ, Mark DB, Lincoff AM, et al. Outcomes at 1 year and economic
implications of platelet glycoprotein IIb/IIIa blockade in patients
undergoing coronary stenting: results from a multicentre randomised trial:
EPISTENT Investigators Evaluation of Platelet IIb/IIIa Inhibitor for
Stenting. Lancet. 1999;354:2019 –2024.
19. Breslow NE, Day NE. Statistical methods in cancer research. Vol 1.
Lyon, France: International Agency for Research on Cancer; 1980.
20. Keane D, Azar AJ, de Jaegere P, et al. Clinical and angiographic outcome
of elective stent implantation in small coronary vessels: an analysis of the
BENESTENT trial. Semin Interv Cardiol. 1996;1:255–262.
21. Edelman ER, Rogers C. Stent-versus-stent equivalency trials: are some
stents more equal than others? Circulation. 1999;100:896 – 898.
22. Kastrati A, Dirschinger J, Boeckstegers P, et al. Influence of stent design
on one-year outcome after coronary stent placement: a randomized com-
parison of 5 stent types in 1147 unselected patients. Catheter Cardiovasc
Interv. 2000;50:290 –297.
23. Schühlen H, Kastrati A, Dirschinger J, et al. Intracoronary stenting and
risk for major adverse cardiac events during the first month. Circulation.
1998;98:104 –111.