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From the Service de Cardiologie B, Hôpital Cardiologique, Lille,
France.
Correspondence to Michel E. Bertrand, MD, Service de Cardiologie B, Hôpital Cardiologique, Boulevard du Professeur J. Leclercq, 59037 Lille Cedex, France. E-mail bertrandme{at}aol.com
Methods and Results—One hundred three consecutive patients (107
vessels) underwent repeat percutaneous intervention for
the treatment of in-stent restenosis and were entered in a
prospective angiographic follow-up program. Repeat balloon angioplasty
was performed at 93 lesions (87%) and additional stenting at 14
lesions (13%). The primary success rate was 98%. Six-month
angiographic follow-up was performed in 85% of eligible patients.
Restenosis was determined by quantitative angiography.
Restenosis defined as a >50% diameter stenosis at
follow-up was observed at 22% of lesions. The rate of target-lesion
revascularization at 6 months was 17%. Repeat
intervention for diffuse in-stent restenosis and severe
stenosis before repeat intervention were associated with
significantly higher rates of recurrent restenosis.
Conclusions—The overall restenosis rate after repeat
intervention for in-stent restenosis is low. The subgroup of
patients with diffuse and/or severe in-stent restenosis,
however, is at higher risk of recurrent restenosis and may
benefit from alternative therapeutic strategies.
Primary success (<50% residual stenosis with no major
complication, ie, myocardial infarction, bypass surgery during
hospitalization, or in-hospital death) was obtained in 101 (98%) of
the patients. Before hospital discharge, all patients were
prospectively asked to undergo systematic 6-month angiographic
follow-up to detect recurrent restenosis. Two patients died
during the follow-up period. Angiographic follow-up was obtained in 84
(85%) of the eligible patients at a mean (±SD) of 6.3±2.1 months
after the procedure. The 15 remaining patients were contacted by
telephone at 6 months; all were asymptomatic and refused
angiographic follow-up.
Stenting and Repeat Angioplasty
Angiographic Analysis
Quantitative computer-assisted angiographic measurements were performed
in matched projections with use of the CMS
system.9 Patients received intracoronary
isosorbide dinitrate to achieve maximal vasodilation.
Statistical Analysis
The quantitative angiographic measurements in the 87 lesions with
angiographic follow-up are shown in Table 2
As a consequence of the growing indications for CS, it is of critical
importance to assess the efficacy of the potential treatment strategies
for patients with in-stent restenosis. Previous
studies3 4 5 have reported high angiographic
restenosis rates after repeat balloon angioplasty for in-stent
restenosis. This has prompted investigation of the possible use
of nonballoon techniques (eg, rotational atherectomy, directional
atherectomy, and laser) as an alternative to repeat balloon
angioplasty.10 11 These studies reporting high
recurrent restenosis rates, however, had low angiographic
follow-up rates that may have led to an overestimation of the true
angiographic restenosis rate. Indeed, this was pointed out by
Baim et al.3 Discordant results were recently
published by Reimers et al7 showing a very low
rate of recurring clinical events in a series of 124 consecutive
patients undergoing repeat angioplasty for in-stent restenosis;
in that study, however, angiographic follow-up was not routinely
performed and was obtained in only 19% of the patients.
In the present study, the angiographic follow-up rate was 85%.
Moreover, the follow-up angiograms were analyzed by use of
quantitative coronary angiography performed by independent
observers. The overall 22% rate of angiographic restenosis is
concordant with the good long-term clinical outcome reported by Reimers
et al7 and supports the use of repeat balloon
angioplasty as primary treatment for in-stent restenosis.
Although the overall angiographic outcome was good, repeat intervention
for diffuse and severe in-stent restenosis was associated with
a high rate of recurrent restenosis; the optimal treatment for
these patients will need to be determined in randomized studies.
Because the high propensity of these patients to develop recurrent
restenosis may be related to residual plaque burden after
repeat angioplasty, additional studies are needed to investigate the
effect of debulking strategies in patients with diffuse
restenosis.10 11 Another strategy may be
repeat stent implantation. In the present study, the rate of
recurrent restenosis after repeat stent implantation was low;
the number of patients with repeat stent implantation is, however, too
small to draw definite conclusions.
There are at least two limitations to the present study.
First, despite the fact that to the best of our knowledge, this study
is the largest study with systematic angiographic follow-up reported to
date, the number of patients included was relatively modest, and larger
studies will have to be designed to confirm our findings; this will be
especially important for subgroup analyses. Second, this study
was solely focused on the 6-month angiographic end point; however, our
results are concordant with those of a study focused on long-term
clinical outcome.7
In conclusion, stent restenosis is an increasing problem.
In-stent balloon angioplasty appears to be a safe treatment strategy
associated with low restenosis rates in focal lesions. Diffuse
restenoses are at higher risk of recurrent restenosis
and may benefit from alternative therapeutic approaches.
Received November 3, 1997;
revision received December 3, 1997;
accepted December 4, 1997.
2.
Fischman DL, Leon MB, Baim DS, Schatz RA, Savage MP,
Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M, Cleman M, Heuser R,
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Shaknovich A, Hirshfeld J, Bailey S, Ellis S, Rake R, Goldberg S. A
randomized comparison of coronary-stent placement and balloon
angioplasty in the treatment of coronary artery disease.
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Reimers B, Moussa I, Akiyama T, Tucci G, Ferraro M,
Martini G, Blengino S, Di Mario C, Colombo A. Long-term clinical
follow-up after successful repeat percutaneous
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© 1998 American Heart Association, Inc.
Brief Rapid Communications
Six-Month Angiographic Outcome After Successful Repeat Percutaneous Intervention for In-Stent Restenosis
Abstract
Top
Abstract
Introduction
Methods
Results
Discussion
References
Background—In-stent
restenosis is an increasing clinical problem. Discordant
results have been published regarding the risk of recurrent
restenosis after repeat angioplasty for the treatment of
in-stent restenosis.
Key Words: angiography • restenosis • stents
Introduction
Top
Abstract
Introduction
Methods
Results
Discussion
References
Recent
studies1 2 have shown that coronary
stenting (CS) reduces restenosis compared with balloon
angioplasty; however, in-stent restenosis may occur in 20% to
30% of cases. Because of the extension of CS indications, the problem
of the treatment of in-stent restenosis has assumed increasing
importance. Although satisfactory short-term results have been reported
with repeat balloon angioplasty, controversy still exists regarding the
recurrent restenosis rate.3 4 5 6 7 The
present study describes the 6-month angiographic outcome, assessed
with quantitative angiography, of 103 consecutive patients who
underwent repeat percutaneous intervention for the
treatment of in-stent restenosis.
Methods
Top
Abstract
Introduction
Methods
Results
Discussion
References
Patients
As part of a systematic follow-up program to detect
restenosis 6 months after successful CS, 647 consecutive
patients underwent coronary angiography between August 1994 and
April 1997 in our institution. One hundred sixty-two patients (25%)
had restenosis by quantitative coronary angiography
(>50% diameter stenosis). Of these 162 patients with stent
restenosis, 51 (31%) were treated medically, 8 (5%) underwent
bypass surgery, and 103 (64%) underwent a repeat
percutaneous intervention; these latter 103 patients
form our study population.
CS was performed as previously described.8
High inflation pressures were used for final in-stent dilatation. The
antithrombotic regimen comprised ticlopidine (250 mg twice daily for 6
weeks) and aspirin (160 to 300 mg daily indefinitely). Repeat balloon
angioplasty was performed by use of standard techniques. Additional
stents were implanted in a minority of cases (13%); other techniques
such as rotablator or laser were not used in this series. The same
antithrombotic regimen (ticlopidine and aspirin) was given for 6 weeks
after repeat angioplasty.
Qualitative analyses were performed independently by two
experienced interventional cardiologists. Disagreements were resolved
by a further joint reading. The location of the restenotic
lesions with respect to the stented segment was classified as being
within the stent body or at the proximal or distal margin of the stent.
Stenosis within the stent or at the margins was further
classified as being either diffuse (>50% lumen narrowing >10 mm
in length) or focal.
Data are presented as mean±SD. Comparisons between
groups for continuous data were made with unpaired Student's
t tests. Differences between proportions were assessed by
2 analysis.
Results
Top
Abstract
Introduction
Methods
Results
Discussion
References
Patient and lesion characteristics at the time of the initial
stenting procedure and at the time of the repeat procedure are shown in
Table 1
. Most of the patients had
high-pressure implantation of either Palmaz-Schatz or Wiktor stents.
The repeat procedure was most frequently performed for recurrent
unstable (23%) or stable (48%) angina despite antianginal treatment;
17% of patients were asymptomatic on antianginal treatment
but had evidence of ischemia during noninvasive testing; 12%
of patients were asymptomatic on antianginal treatment,
could not perform a maximal exercise test, and underwent repeat
revascularization based on the decision of the
cardiologist who performed the angiography. The repeat procedure was
balloon angioplasty in the majority (87%) of cases and "in-stent
stenting" in the remaining cases (13%). In-stent restenosis
was most often focal (71%) and located within the body of the stent
(80%). The proportion of focal (versus diffuse) restenosis
(68%) was similar in the 59 patients who did not undergo repeat
revascularization.
View this table:
[in a new window]
Table 1. Clinical, Angiographic, and Procedural
Characteristics . Recurrent restenosis (>50%
diameter stenosis by quantitative angiography) was observed at
19 lesions (22%). The rate of target-lesion
revascularization at 6 months was 17%. As shown in
Table 3, repeat intervention for diffuse
in-stent restenosis or severe stenosis before repeat
intervention was associated with significantly higher rates of
recurrent restenosis (rate of recurrent restenosis:
diffuse=42%, focal=14%, P<.006; diameter stenosis
>70% before repeat intervention=33%, diameter stenosis
<70% before repeat intervention=11%, P<.02). The rate of
recurrent restenosis was 23% when the repeat intervention was
balloon angioplasty and 15% when it was repeat stenting
(P=NS).
View this table:
[in a new window]
Table 2. Quantitative Angiography (n=87 Lesions With
Angiographic Follow-up)
View this table:
[in a new window]
Table 3. Predictors of Recurrent In-Stent Restenosis
Discussion
Top
Abstract
Introduction
Methods
Results
Discussion
References
Our results demonstrate that repeat balloon angioplasty for the
treatment of in-stent restenosis has a high immediate success
rate and a favorable 6-month angiographic outcome.
References
Top
Abstract
Introduction
Methods
Results
Discussion
References
1.
Serruys PW, de Jaegere P, Kiemeneij F, Macaya C,
Rutsch W, Hendrickx G, Emanuelsson H, Marco J, Legrand V, Materne P,
Belardi J, Sigwart U, Colombo A, Goy JJ, Van Den Heuvel P, Delcan J,
Morel MA. A comparison of balloon-expandable stent implantation with
balloon angioplasty in patients with coronary artery disease.
N Engl J Med. 1994;331:489–495.
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