(Circulation. 2000;101:2484.)
© 2000 American Heart Association, Inc.
Clinical Investigation and Reports |
Treatment of In-Stent Restenosis With Excimer Laser Coronary Angioplasty Versus Rotational Atherectomy
Comparative Mechanisms and Results
From the Cardiovascular Research Foundation, Lenox Hill Heart & Vascular Institute, New York, NY (R.M., G.D., A.J.L., G.W.S., M.B.L.), and the Intravascular Ultrasound Imaging and Cardiac Catheterization Laboratory, Washington Hospital Center, Washington, DC (G.S.M., R.W., A.A., L.F.S., A.D.P., K.M.K.).
Correspondence to George Dangas, MD, PhD, Cardiovascular Research Foundation, 55 E 59th St, 6th Floor, New York, NY 10022. E-mail gdangas{at}compuserve.com
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Abstract |
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Background—Atheroablation yields improved clinical results for balloon angioplasty (percutaneous transluminal coronary angioplasty, PTCA) in the treatment of diffuse in-stent restenosis (ISR).
Methods and Results—We compared the mechanisms and clinical results of excimer laser coronary angioplasty (ELCA) versus rotational atherectomy (RA), both followed by adjunct PTCA; 119 patients (158 ISR lesions) were treated with ELCA+PTCA and 130 patients (161 ISR lesions) were treated with RA+PTCA. Quantitative coronary angiographic and planar intravascular ultrasound (IVUS) measurements were performed routinely. In addition, volumetric IVUS analysis to compare the mechanisms of lumen enlargement was performed in 28 patients with 30 lesions (16 ELCA+PTCA, 14 RA+PTCA). There were no significant between-group differences in preintervention or final postintervention quantitative coronary angiographic or planar IVUS measurements of luminal dimensions. Angiographic success and major in-hospital complications with the 2 techniques were also similar. Volumetric IVUS analysis showed significantly greater reduction in intimal hyperplasia volume after RA than after ELCA (43±14 versus 19±10 mm3, P<0.001) because of a significantly higher ablation efficiency (90±10% versus 76±12%, P=0.004). However, both interventional strategies had similar long-term clinical outcome; 1-year target lesion revascularization rate was 26% with ELCA+PTCA versus 28% with RA+PTCA (P=NS).
Conclusions—Despite certain differences in the mechanisms of lumen enlargement, both ELCA+PTCA and RA+PTCA can be used to treat diffuse ISR with similar clinical results.
Key Words: stents • restenosis • lasers • ablation • angioplasty • revascularization
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Introduction |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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Intracoronary stents reduce restenosis compared with balloon angioplasty (percutaneous transluminal coronary angioplasty, PTCA).1 2 However, in-stent restenosis (ISR) remains an important clinical problem. ISR is caused by intimal hyperplasia (IH).3 4 Intravascular ultrasound (IVUS) imaging has shown that the mechanism of lumen enlargement during PTCA of ISR is a combination of additional stent expansion and tissue extrusion outside the stent segment.5 Although ISR can be treated with PTCA, the recurrence rate, especially in diffuse ISR, is very high.5 6 In a comparative study of ISR therapy, we showed better long-term clinical outcome with excimer laser coronary angioplasty (ELCA) plus adjunct PTCA than with PTCA alone.7 The long-term outcome after rotational atherectomy (RA) has also been reported to be superior to historic controls of PTCA treatment of ISR.8 However, differences in ablation efficiency and clinical efficacy between these atheroablative techniques have not been studied.
In the present study, we compared the mechanism, atheroablative efficiency, and clinical results of ELCA versus RA (both followed by adjunct PTCA) for the treatment of diffuse ISR.
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Methods |
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This study included 249 patients with diffuse (>10 mm in length) ISR in tubular slotted or multicellular stents. Interventional techniques were either ELCA+PTCA (n=119 patients, n=158 lesions) or RA+PTCA (n=130 patients, n=161 lesions). This represents a consecutive series of patients with diffuse ISR treated at our institution over a period of 3 years. The decision to perform atheroablation with ELCA versus RA was made by the operator. Exclusions were limited to patients participating in brachytherapy protocols (n=273), focal ISR (n=401), and saphenous vein graft ISR (n=83).
Procedure
In lesions treated with ELCA Vitesse catheters
(Spectranetics/Advanced Interventional Systems), the mean value of the
largest laser fiber catheter used was 1.81±0.18 mm in diameter;
the maximum catheter size was 1.4 mm in 19 (12%), 1.7 mm in
59 (37%), and 2.0 mm in 80 (51%) cases. The laser
catheter–to–artery ratio was 0.72±0.21. A single-pass technique was
used in 52%. Energy densities were 35 to 55
mJ/mm2 (mean 45.7±5.5
mJ/mm2). A "saline flush" technique was used
in all cases. Adjunct PTCA was performed with nominal balloon size
3.6±0.6 mm, balloon-to-artery ratio 1.3±0.3, and maximum
inflation pressure 17±3 atm. Additional stents were placed in 41
(25.6%) lesions.
RA was performed with the use of 1.50- to 2.15-mm diamond-coated metal burrs (Boston Scientific). The mean value of the largest burr used was 1.89±0.18 mm in diameter; maximum size was 1.5 mm in 15 (9.5%), 1.75 mm in 48 (30%), 2.0 mm in 86 (53%), and 2.15 mm in 12 (7.5%) of cases. The burr-to-artery ratio was 0.74±0.20. Adjunct PTCA was performed with nominal balloon size 3.2±0.4 mm, balloon-to-artery ratio was 1.4±0.4, and maximum inflation pressure was 14±5 atm. Additional stents were placed in 48 (26.2%) lesions.
Angiographic Analysis
Quantitative coronary angiographic analysis was
performed by a core angiographic laboratory blinded to the results of
the IVUS analysis and clinical follow-up. A previously
validated system (ARTREK, Quantitative Cardiac Systems) was used with
the contrast-filled catheter as the calibration standard. Minimal lumen
diameter, reference diameter, and percent diameter stenosis
were measured before atheroablation and after atheroablation plus
adjunct PTCA (final) from multiple projections; the results from
the single "worst" view were recorded. Ostial lesions begin at
<3 mm of the major coronary artery
ostium.9
IVUS Imaging Protocol
Studies were performed with 1 of 2 commercially available
systems. The first system (CVIS/Inter Therapy Inc) incorporated a
single-element, 25-MHz transducer and an angled mirror mounted on the
tip of a flexible shaft, which was rotated at 1800 rpm within a 3.9F
short monorail polyethylene imaging sheath to form planar
cross-sectional images in real time (used in 15 [4.7%] cases). The
second system (Boston Scientific Corp/Cardiovascular
Imaging Systems Inc) used a single-element, 30-MHz beveled transducer
mounted on the end of flexible shaft and rotated at 1800 rpm within a
3.2F short monorail imaging sheath (used in 304 [95.3%] cases). With
both systems, the transducer was withdrawn automatically at 0.5
mm/s to perform the imaging sequence.
IVUS imaging10 was performed after administration of 0.2
mg intracoronary nitroglycerin. The ultrasound
catheter was advanced 
10 mm beyond the target lesion, and an
imaging run was performed at the aorto-ostial junction. Studies were
recorded only during pullback onto half-inch, high-resolution s-VHS
for off-line analysis. IVUS imaging was routinely performed
before atheroablation and after atheroablation plus adjunct PTCA
(final).
Quantitative Planar IVUS Measurements
Two-dimensional, cross-sectional area (CSA), and length
measurements by IVUS have been validated.11 12 13 14 15 16 17 18 Area
measurements were performed with the use of a commercially available
program for computerized planimetry (TapeMeasure, Indec Systems Inc) at
the image slice with the smallest lumen CSA and included stent, lumen,
and IH (stent minus lumen) CSA. When the plaque encompassed the
catheter, the lumen was assumed to be the physical size of the imaging
catheter. The proximal and distal references were defined as the most
normal-looking cross section (largest lumen with the least plaque)
within 10 mm proximal and distal to the ISR lesion but before side
branches. ISR length was the axial length of the stent (mm) in which IH
CSA was 
75% stent CSA. If the ISR lesion continued into the
contiguous reference segment, the ISR length included the length of the
reference segment whose lumen CSA was <25% of the adjacent stent
margin CSA. At a pullback speed of 0.5 mm/s, 2 seconds of the
videotape playback is equal to 1 mm of axial stent length.
Volumetric IVUS Analysis
This analysis included all patients who had complete
IVUS imaging before intervention, after atheroablation, and after
adjunct PTCA (final). Baseline characteristics of this subset were
similar to the entire cohort. All lesions included in this subset were
ISR within Palmaz-Schatz stents and were treated with 2.0-mm ELCA
catheters or 2.0-mm RA burrs. IVUS imaging was performed with the 3.2F
system. On playback of the recorded studies, IVUS images were
measured every 1 mm of axial ISR length. Stent, lumen, and IH
volumes were calculated by means of Simpson’s
rule.3 4 7
The impact of atheroablation on lumen enlargement was assessed by
comparing postatheroablation and preatheroablation measurements; the
effect of adjunct PTCA was evaluated by comparing final and
postatheroablation measurements.7 Ablation efficiency was
normalized to the maximum ablation catheter size and was calculated as
the ratio of the lumen volume after ablation divided by the theoretical
cylinder with CSA equal to the area of the maximum ELCA catheter or RA
burr used and with length equal to the ISR length with a preablation
lumen area smaller than the ELCA catheter or RA burr
(Figure
).
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Clinical Data and Follow-Up
Patient charts were reviewed, and clinical, demographic, and
laboratory data were entered prospectively into the database by a
dedicated Data Coordinating Center. Clinical follow-up was performed
with telephone contacts or office visits at 1, 3, 6, and 12 months.
Major late clinical events were source documented and adjudicated,
including death, Q-wave myocardial infarction, and
ischemia-driven target lesion site
revascularization (TLR;
percutaneous or surgical).
Statistical Analysis
Statistical analysis was performed with the use of
StatView 4.02 (Abacus Concepts) or SAS (Statistical Analysis
Systems, SAS Institute Inc). Categorical data were presented as
frequencies and compared with Fisher’s exact test. Continuous data
were presented as mean±SD and compared with paired and
unpaired Student’s t tests. We conducted
multivariate logistic regression analysis to
investigate a potential difference in TLR between the 2 groups,
controlling for baseline variables with significant between-group
differences. A value of P<0.05 was considered significant;
probability values >0.10 are reported as not significant.
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Results |
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Baseline characteristics are shown in Table 1
. More left anterior descending
lesions were treated with ELCA+PTCA than with RA+PTCA (38% versus
23%, P=0.01). The groups had similar percentages of lesions
>20 mm in length (60% in both groups) and of total occlusions
(7% in the ELCA+PTCA versus 5% in the RA+PTCA group,
P=NS). Each group included 58 (36%) lesions with recurrent
ISR.
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Procedural Results
We observed no perforations, 1 (0.6%) abrupt closure in the
ELCA+PTCA group, and 2 (1.1%) no-reflow cases in the RA+PTCA group
(P=NS for angiographic complications). Major in-hospital
complications were also similar in the 2 groups: 1 (0.7%) death in
each group and 4 bypass surgery operations in the ELCA+PTCA group
(3.3% versus 0%, P=NS). There were no Q-wave myocardial
infarctions in either group. We documented postprocedure elevation of
creatine kinase-MB >5x normal in 11% (n=14) with ELCA+PTCA versus
8% (n=11) with RA+PTCA (P=NS); creatine kinase-MB >2x
normal occurred 28% and 23%, respectively (P=NS).
There were no differences with respect to preprocedure and final
luminal dimensions by quantitative angiography (Table 2). The acute gain was 1.50±0.38 mm
with ELCA+PTCA and 1.53±0.41 mm with RA+PTCA
(P=NS).
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Both groups had similar preatheroablation and final dimensions by
quantitative planar IVUS analysis as well (Table 3). There was a trend toward a smaller
reduction in IH CSA with ELCA+PTCA than with RA+PTCA (2.92±1.01 versus
3.38±1.08 mm2, P=0.09). The
contribution of stent expansion to the final luminal gain was 15% in
the ELCA+PTCA group versus 13% in the RA+PTCA group
(P=NS).
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Volumetric IVUS Analysis
This analysis included only those patients with routine
preatheroablation, postatheroablation, and final IVUS imaging. After
both ELCA and RA, lumen gain was entirely due to
atheroablation/extrusion; we observed no additional stent expansion. In
the ELCA subgroup, 27% of the overall luminal gain
(final-preatheroablation) was due to ELCA, and 73% was due to adjunct
PTCA (54% additional stent expansion and 46% tissue extrusion). In
the RA subgroup, 46% of the luminal gain (final-preatheroablation) was
due to RA and 54% was due to adjunct PTCA (52% additional stent
expansion and 48% tissue extrusion). Ablation efficiency was higher
with RA compared with ELCA: 90±10% versus 77±12%
(P=0.004) (Table 4). However,
adjunct PTCA was responsible for >50% of the overall lumen gain in
both groups and equalized the final lumen dimensions (by both
quantitative angiography and IVUS) in the 2 groups.
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One-Year Clinical Outcome
Long-term results are shown in Table 5. No significant difference was
documented between the 2 groups; TLR rates were almost identical
(26.2% with ELCA+PTCA versus 27.9% with RA+PTCA, P=NS).
TLR was also similar in both groups when patients with additional stent
implantation were excluded: 29.8% ELCA+PTCA versus 26.3% RA+PTCA
(P=NS). By multivariate analysis,
controlling for baseline between-group differences (lesion location),
the selection of interventional technique (ELCA+PTCA versus RA+PTCA)
still was not predictive of TLR.
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Discussion |
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Atheroablative techniques have been advocated for the treatment of diffuse ISR in response to the poor long-term results achieved with PTCA alone (restenosis rates 54% to 85%).5 6 7 The superior results reported after atheroablation plus adjunct PTCA have been attributed to the greater reduction of in-stent neointimal tissue. If atheroablation per se was a strong determinant of clinical outcome, then differences between atheroablative devices with respect to ablation efficiency and the amount of IH removed should translate into improved long-term clinical benefit. In the present study of diffuse ISR, both ELCA+PTCA and RA+PTCA improved lumen dimensions by a combination of tissue ablation, tissue extrusion, and additional stent expansion. Although RA achieved greater IH ablation, this was not accompanied by improved 1-year clinical outcome.
Mechanistic Comparison of ELCA+PTCA Versus RA+PTCA
In vitro and in vivo animal models originally suggested that
excimer lasers precisely cut through atheroma, including
calcium, without harmful thermal injury.19 20 21 22 23 24 Conversely,
IVUS has indicated that the mechanism of lumen enlargement after ELCA
of nonstented lesions was a combination of tissue ablation (76% of
lumen enlargement) and vessel expansion (24% of lumen enlargement)
with no evidence of calcium ablation.24 In the present
study, volumetric IVUS analysis showed that all of the lumen
enlargement during ELCA treatment of ISR was the result of tissue
ablation. This was probably related to the absence of calcium in ISR
lesions and to the scaffolding effects of endovascular stents that may
limit laser-induced vessel expansion. As with ELCA, we found luminal
enlargement after RA to be exclusively due to tissue ablation. This was
similar to a previous volumetric IVUS study assessing tissue ablation
after RA of nonfibrocalcific plaque.25
We found 77% ablation efficiency for ELCA, which is similar to the theoretical ablation capacity of the 2.0 Vitesse ELCA catheter and to previous in vitro data with the same catheter.26 Similar ablation efficiency has also been reported for the 1.7 Vitesse ELCA catheter.26 Newer-generation "optimally spaced" ELCA catheters have been shown in vitro to increase ablation efficiency by 20% compared with the currently approved concentric catheters,26 with a potential to equalize the difference that we observed in ablation efficiency between ELCA and RA. These catheters were not available at the time of the present study.
The 90% ablation efficiency we found for RA was similar to previous reports in non-ISR lesions.27 28 29 The marginal differences may reflect different elastic properties of lesions within a stent as compared with the previous reports on RA in de novo lesions.29 In the present volumetric IVUS analysis, only 2.0-mm burrs were studied. Ablation efficiency has not been shown to differ among different burr sizes in experimental conditions (D. Dillard, Boston Scientific Engineering Department, Seattle, Wash; personal communication).
The mechanism of adjunct PTCA was similar in both groups, through an almost equal magnitude of tissue extrusion and stent expansion. The magnitude of additional stent expansion during adjunct PTCA (15% and 19% in the 2 groups) was similar to stand-alone PTCA in previous volumetric IVUS studies as reported by us and others.5 7
Short-Term Clinical Results
Despite these mechanistic observations, both ELCA+PTCA and
RA+PTCA achieved similar final lumen dimensions by angiography and
planar IVUS analysis. Thus, the greater ablation efficiency of
RA was balanced by a relatively smaller contribution of adjunct PTCA to
the final lumen dimensions. However, the current study also showed the
limitations of these techniques. First, the mean final angiographic
residual diameter stenosis measured 18% to 22%. Second,
despite ablation with both ELCA and RA, there was still significant
residual neointimal tissue within the stent (27% after
ELCA+PTCA and 29% after RA+PTCA.
Long-Term Clinical Results
In a previous study comparing ELCA+PTCA versus PTCA alone, we
reported superior long-term results with ELCA+PTCA, but the use of ELCA
per se was not an independent predictor of TLR.7 The
independent determinant of late outcome was the final procedural
luminal gain, whether by ablation, by tissue extrusion, or by
additional stent expansion.7 In the present study, the
similar final lumen dimensions after ELCA+PTCA and RA+PTCA were
accompanied by similar long-term results (Table 5
).
Atheroablation per se may not offer a specific long-term advantage over
tissue extrusion or stent expansion as long as final lumen dimensions
were maximized. One possible explanation is that diffuse ISR may, in
some patients, represent a biologically aggressive response
that cannot be counteracted by the simple approach of atheroablation
regardless of the efficiency. On the other hand, we cannot exclude the
possibility that catheters with greater ablation efficiency might have
yielded greater reduction in IH hyperplasia and possibly incur an
additional clinical benefit.
The 2 interventional techniques had a 26% to 28% TLR rate. This
"relatively" low TLR may be explained by 2 factors. (1) The 1-year
mortality rate was 5% to 8%; these patients might otherwise have
presented with recurrence. (2) A significant number
of patients were excluded from this analysis because of
participation in vascular brachytherapy protocols; these patients may
have represented a higher-risk group. The placebo arm of
the Washington Radiation In-Stent Restenosis Trial had a
clinical recurrence rate of 60%, whereas the active
treatment arm (192Ir) had a markedly lower
recurrence rate.30
Study Limitations
This study was a retrospective analysis of lesions treated
with ELCA+PTCA or RA+PTCA; lesions were not randomized to the 2
treatment strategies. The operators were not blinded to any of the IVUS
imaging runs. The volumetric IVUS methods used to separate IH tissue
ablation from extrusion was available only in the subset of patients
with IVUS imaging after atheroablation (before PTCA). Since final IVUS
imaging was routinely performed immediately after completion the
intervention, this study was unable to investigate the recently
reported time-dependent effect of tissue reintrusion within the treated
segment.31 Although the type and length of the initially
restenosed stents were unavailable, we have previously documented that
the length of IH (measured by IVUS) rather than the stent length is a
predictor of recurrent ISR.32 We do not believe that stent
recoil contributed significantly to the results because tubular-slotted
and multicellular stents do not recoil.33 34 It is
possible that with more aggressive tissue ablation, the final
procedural result might have been improved in both groups. However, the
anticipated (but not yet proven) clinical benefit from even more
aggressive atheroablation should be carefully evaluated against the
risk of procedural complications, which were very small with the
present approach.
Conclusions
Despite the higher ablation efficiency of RA compared with ELCA,
ELCA+PTCA and RA+PTCA yield similar long-term clinical results in the
treatment of diffuse ISR in native coronary arteries.
Received August 5, 1999; revision received November 22, 1999; accepted December 12, 1999.
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V. Spanos, G. Stankovic, J. Tobis, and A. Colombo The challenge of in-stent restenosis: insights from intravascular ultrasound Eur. Heart J., January 2, 2003; 24(2): 138 - 150. [Full Text] [PDF]
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R. Prpic, P. S. Teirstein, J. P. Reilly, J. W. Moses, P. Tripuraneni, A. J. Lansky, J.-A. Giorgianni, S. Jani, S. C. Wong, R. D. Fish, et al. Long-Term Outcome of Patients Treated With Repeat Percutaneous Coronary Intervention After Failure of {gamma}-Brachytherapy for the Treatment of In-Stent Restenosis Circulation, October 29, 2002; 106(18): 2340 - 2345. [Abstract] [Full Text] [PDF]
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J. vom Dahl, U. Dietz, P. K. Haager, S. Silber, L. Niccoli, H. J. Buettner, F. Schiele, M. Thomas, P. Commeau, D. R. Ramsdale, et al. Rotational Atherectomy Does Not Reduce Recurrent In-Stent Restenosis: Results of the Angioplasty Versus Rotational Atherectomy for Treatment of Diffuse In-Stent Restenosis Trial (ARTIST) Circulation, February 5, 2002; 105(5): 583 - 588. [Abstract] [Full Text] [PDF]
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M. T. Castagna, G. S. Mintz, R. Waksman, J. M. Ahmed, A. Maehara, A. E. Ajani, A. B. Bui, L. F. Satler, W. O. Suddath, K. M. Kent, et al. Comparative Efficacy of {gamma}-Irradiation for Treatment of In-Stent Restenosis in Saphenous Vein Graft Versus Native Coronary Artery In-Stent Restenosis: An Intravascular Ultrasound Study Circulation, December 18, 2001; 104(25): 3020 - 3022. [Abstract] [Full Text] [PDF]
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S.-W. Park, M.-K. Hong, D. H. Moon, S. J. Oh, C. W. Lee, J.-J. Kim, and S.-J. Park Treatment of diffuse in-stent restenosis with rotational atherectomy followed by radiation therapy with a rhenium-188-mercaptoacetyltriglycine-filled balloon J. Am. Coll. Cardiol., September 1, 2001; 38(3): 631 - 637. [Abstract] [Full Text] [PDF]
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M. Adamian, A. Colombo, C. Briguori, T. Nishida, F. Marsico, C. Di Mario, R. Albiero, I. Moussa, and J. W. Moses Cutting balloon angioplasty for the treatment of in-stent restenosis: a matched comparison with rotational atherectomy, additional stent implantation and balloon angioplasty J. Am. Coll. Cardiol., September 1, 2001; 38(3): 672 - 679. [Abstract] [Full Text] [PDF]
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